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Sleeping well with cancer: a systematic review of cognitive behavioral therapy for insomnia in cancer patients

Sleeping well with cancer: a systematic review of cognitive behavioral therapy for insomnia in... Neuropsychiatric Disease and Treatment Dovepress open access to scientific and medical research Open Access Full Text Article Review Sleeping well with cancer: a systematic review of cognitive behavioral therapy for insomnia in cancer patients Sheila N Garland Abstract: Individuals with cancer are disproportionately affected by sleep disturbance and insomnia relative to the general population. These problems can be a consequence of the Jillian A Johnson psychological, behavioral, and physical effects of a cancer diagnosis and treatment. Insomnia Josee Savard 4 often persists for years and, when combined with already high levels of cancer-related distress, Philip Gehrman may place cancer survivors at a higher risk of future physical and mental health problems and Michael Perlis poorer quality of life. The recommended first-line treatment for insomnia is cognitive behavioral Linda Carlson therapy for insomnia (CBT-I), a non-pharmacological treatment that incorporates cognitive and Tavis Campbell behavior-change techniques and targets dysfunctional attitudes, beliefs, and habits involving Department of Family Medicine sleep. This article presents a comprehensive review of the literature examining the efficacy of and Community Health, University CBT-I on sleep and psychological outcomes in cancer patients and survivors. The search revealed of Pennsylvania, Philadelphia, PA, USA; Department of Psychology, 12 studies (four uncontrolled, eight controlled) that evaluated the effects of CBT-I in cancer University of Calgary, Calgary, AB, patients or survivors. Results suggest that CBT-I is associated with statistically and clinically Canada; School of Psychology, Laval significant improvements in subjective sleep outcomes in patients with cancer. CBT-I may also University, Quebec City, QC, Canada; Department of Psychiatry, University improve mood, fatigue, and overall quality of life, and can be successfully delivered through of Pennsylvania, Philadelphia, PA, USA; a variety of treatment modalities, making it possible to reach a broader range of patients who Department of Oncology, University may not have access to more traditional programs. Future research in this area should focus on of Calgary, Calgary, AB, Canada the translation of evidence into clinical practice in order to increase awareness and access to effective insomnia treatment in cancer care. Keywords: CBT-I, cancer, insomnia, sleep, systematic review, quality of life, survivors Background Prevalence of sleep disturbances and insomnia in cancer Cancer is one of the leading causes of global morbidity and mortality, second only to heart disease. The global burden of cancer is expected to reach 21.4 million individu- als by 2030. Since the early 1990s, early detection and improved treatment methods have led to an overall reduction in cancer death rates and the prevention of approxi- mately 1,024,400 cancer deaths. Improved survival rates mean that more people will require ongoing treatment for the persistent physical and psychological side effects of a cancer diagnosis. An important but often overlooked side effect of cancer diagnosis 4–7 and treatment is sleep disturbance and insomnia. Prevalence rates for insomnia in individuals with cancer range from 30% to 60%, depending on the definition, time of 8–10 assessment, and measurement tool used. According to the most recent Diagnostic Correspondence: Tavis Campbell Department of Psychology, University and Statistical Manual of Mental Disorders, fifth edition, nosology, “insomnia” is of Calgary, 2500 University Drive Nw, defined as dissatisfaction with sleep quality or quantity characterized by difficulty Calgary, AB, T2N 1N4, Canada email t.s.campbell@ucalgary.ca initiating sleep, maintaining sleep, or early morning awakenings that cause significant submit your manuscript | www.dovepress.com Neuropsychiatric Disease and Treatment 2014:10 1113–1124 Dovepress © 2014 Garland et al. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License. The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further http://dx.doi.org/10.2147/NDT.S47790 permission from Dove Medical Press Limited, provided the work is properly attributed. Permissions beyond the scope of the License are administered by Dove Medical Press Limited. Information on how to request permission may be found at: http://www.dovepress.com/permissions.php Garland et al Dovepress distress or impairment in daytime functioning and occur experience sleep difficulty than those without pain, whereas at least three nights per week for at least 3 months despite people with higher levels of emotional distress were 4.5 times adequate opportunity for sleep. The presence of persistent more likely to report problems with sleep than those with low insomnia places patients at a higher risk for psychological distress levels. Considering that sleep disturbance co-occurs 12,13 and physical morbidity and reduced quality of life. with, and significantly contributes to, other cancer-related symptoms, it may be important for interventions to address Chemotherapy as a contributor symptom clusters or to focus on the symptom most associated to disturbed sleep and insomnia with the other conditions. The greater rate of insomnia experienced by cancer patients Disturbed sleep, insomnia, has not only been attributed to the emotional consequences of being diagnosed with cancer but also to the direct effects and quality of life of cancer treatments and their side effects, particularly Not only are cancer-related sleep disturbances widespread – 7,14–16 chemotherapy. In a prospective study of 823 patients representing a major concern for people irrespective of their undergoing chemotherapy, 39.8% reported moderate or stage in the cancer trajectory – they can also negatively severe insomnia symptoms after their first chemotherapy impact overall quality of life and cancer-therapy outcomes. treatment, with symptoms persisting throughout subsequent The relationship between insomnia and quality of life was cycles in two-thirds of patients. A systematic review of 21 explored in a cross-sectional analysis of 954 people with a articles further suggested that sleep disturbances can persist variety of cancer diagnoses. Regardless of age and treat- for up to 1 year post-chemotherapy. The most commonly ment status, higher self-reported insomnia symptoms were reported sleep problem by patients undergoing chemotherapy associated with lower overall quality of life, with particularly is the inability to maintain sleep (63.3%), with disruptions strong associations with poorer subjective health/physical and being attributed to the anxiety and worry related to the cancer psychological/spiritual well-being. Although not conclusive, diagnosis/treatments and the effects of cancer treatments there is also evidence that impaired sleep can have a negative themselves (ie, postsurgical pain/discomfort, overall fatigue, impact on objective health outcomes. Mormont et al reported nausea, nocturnal hot flashes, increased bathroom use, and that metastatic colorectal cancer patients with dysregulated 18–20 steroid-induced agitation). As such, it appears that can- sleep/wake patterns (ie, poorly differentiated activity levels cer treatments, particularly chemotherapy and surgery, may during wake and sleep) were five times more likely to die contribute to an increased risk for developing clinically within 5 years than patients with a more distinguishable cir- significant sleep disturbances and partially account for the cadian rhythm. When assessed using actigraphy, people with higher than average prevalence rates demonstrated in this a dampened circadian rhythm, characterized by flat profiles population. with less activity during the day and more activity during the night, reported more depressive symptoms and worse Disturbed sleep, insomnia, overall quality of life than those with more robust circadian and other cancer consequences rhythms. Together, these studies suggest that the mainte- Sleep disturbances and insomnia frequently co-occur in nance of robust circadian rhythms and consistent and distin- symptom clusters with other commonly reported cancer side guishable sleep and wake patterns have the potential to reduce effects, such as pain, fatigue, psychological distress, and depressive symptomatology, improve overall perception of 21–23 depression. Although the mechanisms involved are not quality of life, and potentially translate into better physical completely understood, the presence of symptom comorbid- outcomes and survival. Although the directionality of these ity in cancer patients might relate to underlying ina fl mmatory effects is not clear, it is possible that intervening anywhere processes common to many of these concerns. This may in the cycle (eg, targeting sleep) may subsequently positively partially explain why these symptoms have demonstrated effect other symptoms and longer-term outcomes. both indirect and direct reciprocal effects; that is, the presence Cognitive behavioral therapy of one influences the incidence and severity of the others. A recent study investigated the relationship between sleep for insomnia (CBT-i) difficulty, self-reported pain, and emotional distress in a Compared with good sleepers, individuals with insom- sample of 2,862 cancer outpatients. Individuals reporting n i a ex h i b i t c og n i t ive , p hy s i o l og i c a l , a n d c o r t i c a l 29,30 clinically significant pain were 2.7 times more likely to hyperarousal; demonstrate particular cognitive patterns submit your manuscript | www.dovepress.com Neuropsychiatric Disease and Treatment 2014:10 Dovepress Dovepress CBT for insomnia in cancer survivors 31,32 and attentional biases; and strongly endorse problematic insomnia comorbid with psychiatric or medical disorders is 33,34 sleep-related beliefs. Cognitive behavioral therapy for as responsive, if not more so, to CBT-I than so-called primary 52,59 insomnia (CBT-I) is a multicomponent intervention devel- insomnia. Several of these trials have also shown that oped to address these interrelated components. Essentially, CBT-I also produces improvements in the comorbid condi- CBT-I has five potential components: sleep restriction, tion. For example, in the context of major depression, CBT-I stimulus control, sleep hygiene, cognitive restructuring, and nearly doubles response and remission rates when added to 35 60 relaxation training. Most modern studies of CBT-I include standard antidepressant therapies. sleep restriction and stimulus control. “Sleep restriction” CBT-I in the context of cancer is thought to be particu- addresses what is believed to be the primary perpetuating larly challenging because of the overlap and chronicity of factor for chronic insomnia – the mismatch between sleep cancer-related side effects that may influence the develop - opportunity and sleep ability. “Stimulus control” targets ment, severity, and persistence of insomnia symptoms. The stimulus “dyscontrol” (the occurrence of a diversity of purpose of the present report is to summarize the effect of non-sleep behaviors in the bedroom) and sets the stage CBT-I in cancer patients and present recommendations for for counterconditioning (ie, the reconditioning of sleep- future research. related stimuli to elicit the physiology of sleep as opposed Methods to the physiology of wakefulness). “Sleep hygiene”, while An independent review of the literature was performed ineffective as a monotherapy, serves to promote behaviors separately by the first and second authors using PubMed, and practices that facilitate sleep and to discourage those MEDLINE , and PsycINFO databases from the earliest that are thought to contribute to insomnia. “Cognitive date available until January 2014. Only studies published restructuring” is used to identify and address thoughts in English were eligible for review. Search terms included and beliefs that may contribute to the development of, or “cancer/neoplasms”, “insomnia”, “cognitive”, “behavioral”, reinforce, behaviors that produce pre-sleep arousal and/ “cognitive behavioral therapy”, “cognitive therapy”, “behav- or performance anxiety. Relaxation training (the original ioral therapy”, “CBT-I”, “CBT”, “treatment”, “intervention”, behavioral intervention for insomnia) is no longer regu- and “sleep disturbances”. Reference lists of the retrieved larly incorporated into CBT-I but is sometimes utilized to articles were reviewed and articles in press were identie fi d by reduce peripheral autonomic arousal and facilitate mental contacting the authors directly. An article was included if it de-arousal. met the following three criteria: 1) cognitive behavior therapy or behavior therapy tailored for insomnia was used as the Evidence for the overall efficacy of CBT-I primary treatment, 2) the target population were people diag- CBT-I, with or without relaxation therapy, is recommended nosed with cancer (either undergoing or having completed by the American Association of Sleep Medicine, is con- primary treatment), and 3) a subjective or objective measure sidered a well-established intervention by the American of sleep was included as a treatment outcome. Once the Psychiatric Association, and has demonstrated efficacy for 40,41 independent search results were compared, any discrepancies treating primary insomnia. In non-cancer groups, CBT-I were resolved through consultation with the final author and has produced larger effects than treatment as usual (TAU), 43,44 consensus was achieved. A total of 12 intervention studies waitlist control groups, pharmacotherapy +/– medication 45–49 50,51 met the inclusion criteria: four were quasi-experimental placebo, relaxation therapy and behavioral placebo, studies (ie, no random assignment to treatment or a control and sleep-hygiene education. Of the studies with long-term condition) and eight were randomized controlled trials follow-ups, the effects of CBT-I have been remarkably dura- (RCTs). We did not identify any articles of CBT-I in cancer ble (up to 2 years time) in a substantial proportion of partici- patients published in non-English journals. pants, and, on several measures, patients continue to improve (if not reach remission) long after treatment is discontinued. Results While most of the treatment evaluation investigations utilize Quasi-experimental studies a form of CBT-I that is in person, one-on-one, and extends over five to ten sessions, there is evidence that CBT-I can of CBT-i in cancer patients 54,55 56 be successfully delivered to groups, by telephone, over Four uncontrolled studies investigating CBT-I in cancer 57 58 the Internet, and with self-help manuals. Finally, there is patients were identified for inclusion ( Table 1). All of these an emerging literature providing clear demonstrations that studies were conducted with non-metastatic cancer patients submit your manuscript | www.dovepress.com Neuropsychiatric Disease and Treatment 2014:10 Dovepress Garland et al Dovepress submit your manuscript | www.dovepress.com Neuropsychiatric Disease and Treatment 2014:10 Dovepress Table 1 Uncontrolled trials of cognitive behavioral therapy for insomnia (CBT-i) in cancer patients Study Year Sample/ Diagnosis/ Tx status Design Assessment Tx description Intervention Outcome Main results sex stage times details measures Davidson 2001 12/males Mixed/no Posttreatment Single group T1 – week 0 SC, RT, SH, CR Group SD: SL, NwAK, ↓ NwAK (0.002), wASO (0.001) et al and females active T2 – week 4 Six session wASO, TST, Se ↑ TST (0.03), Se (,0.001) disease T3 – week 8 weekly ×5, then Sii ↓ sleep-related impairment (,0.001) monthly ×1 HADS, QLQ-C30 No significant ↓ in depression, 60–90 minutes anxiety or ↑ quality of life at T3 Quesnel 2003 10/females Breast/i–iii Posttreatment Multiple- T1 – week 0 SC, SR, CR, SH fatigue Group wASO, TST (PSG) PSG: ↓ wASO (0.02); ↑ Se (0.04) et al baseline T2 – week 8 management, RP eight session iSi 86% clinically significant ↓ in iSi at T3 Single subject T3 – week 32 weekly BDi, STAi, MFi, No significant ↓ in depression, anxiety, 90 minutes QLQ-C30 fatigue or ↑ quality of life at T3 Simeit 2004 229/males Mixed/no Posttreatment Three group T1 – week 0 Patients chose PMR Group PSQi Both Tx groups: et al and females active (PMR, AT, T2 – week 4 or AT. Tx groups Three session QLQ-C30 ↓ SL (,0.001), sleep disturbance disease or UC) T3 – week 10 were provided with weekly (,0.001) T4 – week 34 information on SC, SR, 60 minutes ↑ sleep duration (,0.001), Se (,0.001), CR, SH (not formal sleep quality (,0.001), daytime function CBT-i) (,0.001) All groups ↑ quality of life at T4 Savard 2011 11/females Breast/i–iii Post-radiation Single group T1 – week 0 SC, SR, CR, SH, RP Self-administered SD: SL, wASO, ↓ SL (0.01), wASO ( ,0.001) et al T2 – week 6 DvD/booklet TST, Se ↑ Se (,0.001), TST (ns) T3 – week 18 Six modules iSi ↓ insomnia severity (,0.001) weekly HADS, MFi, Significant ↓ depression (0.03), 60 minutes QLQ-C30, DBAS dysfunctional beliefs (0.001) and ↑ quality of life (0.03). No significant ↓ anxiety or fatigue at T3 Abbreviations: AT, autogenic training; BDi, Beck Depression inventory; CR, cognitive restructuring; DBAS, Dysfunctional Beliefs and Attitudes about Sleep; HADS, Hospital Anxiety and Depression Scale; iSi, insomnia Severity index; MFi, Multidimensional Fatigue inventory; NwAK, number of awakenings; PMR, progressive muscle relaxation; PSG, polysomnography; PSQi, Pittsburgh Sleep Quality index; QLQ-C30, Quality of Life Questionnaire – Cancer; RP, relapse prevention; RT, relaxation training; SC, stimulus control; SE, sleep efficiency; SD, sleep diary; SH, sleep hygiene; SII, Sleep Impairment Index; SL, sleep latency; SR, sleep restriction; STAI, State-Trait Anxiety Inventory; TST, total sleep time; Tx, treatment; UC, usual care; WASO, wake after sleep onset; ns, non-significant; ↑, increase; ↓, decrease. Dovepress CBT for insomnia in cancer survivors (50% breast and 50% mixed diagnoses) who were post- den fi itive prevention trials are required to adequately address treatment. Davidson et al published the first pre-post study this possibility. of a 6-week non-pharmacological sleep therapy program Controlled studies of CBT-i using CBT-I components (stimulus control, relaxation, “worry time”, and sleep hygiene) to improve sleep quality in cancer patients of a heterogeneous group of 12 breast-cancer patients with Eight RCTs of CBT-I in cancer patients were available for insomnia. Pre- to posttreatment effect sizes ranged from review. Two of these trials are reported in separate publica- 0.58 for total sleep time to 2.0 for sleep efficiency, indicat - tions, bringing the number of papers to ten (Table 2). Five ing a statistically and clinically significant improvement in of these studies were conducted in samples of women with patient functioning. Quesnel et al were the next to investigate breast cancer and the remaining three included men and a CBT-I intervention in a sample of ten women with breast women with mixed cancer diagnoses. The majority of studies cancer in a multiple-baseline design. At the end of the (80%) were conducted with patients who had completed treat- study, 50% of the participants met the classification cutoff ment. Half of the studies consisted of in-person group-based for “good sleepers”, designated as 85% sleep efficiency. interventions while the other half were individual-based This percentage increased to 71% at the 6-month follow-up. interventions, of which one delivered CBT-I to individuals Although both of these studies were limited by small sample via the Internet. The intervention length ranged from 5 to 9 sizes and no comparison groups, they provided impetus for weeks, and observed effects tended to be larger in studies larger efficacy trials. that used waitlist or TAU groups rather than attention control In-person psychological therapies, like CBT-I, may groups. Two studies compared CBT-I with another active not always be readily accessible, especially within cancer treatment group. care. Hence, Savard et al investigated the feasibility of The largest trial to date of standard CBT-I for insomnia self-administering CBT-I via 6-weekly DVD/booklets in in cancer was conducted in 2008 by Espie et al. This eleven women with breast cancer. The treatment consisted study assigned 150 heterogeneous posttreatment cancer of standard CBT-I components and was designed to match patients to either a 5-week CBT-I intervention or TAU. what would be delivered via face-to-face treatment. Insomnia The TAU group was intended to represent normal clinical severity and all sleep-diary variables (except total sleep time) practice, whereby physicians were free to offer appoint- demonstrated significant improvements at posttreatment, ments and prescribe sedative medications. Statistically and and these gains were maintained at the 3-month follow-up. clinically significant improvements in subjective measures This preliminary study was followed by a three-arm RCT of sleep were demonstrated for sleep onset latency, wake comparing video-delivered and professionally administered after sleep onset, and sleep efficiency in the CBT-I group, CBT-I to a no-treatment control group; the results of this are with large between-group effect sizes of –0.86, –0.97, and described in the next section. 1.09, respectively. These results translated into a reduction While CBT-I has largely been standardized in its delivery, of approximately 1 hour in sleep onset latency and time important questions remain about the adequate “dose” or nec- spent awake during the night compared with no change essary delivery required to produce treatment effects. Simeit in the TAU group. These improvements in sleep outcomes et al incorporated components of CBT-I into a multimodal were significantly related to increased quality of life and psychological intervention for 229 inpatients at a cancer reha- reduced daytime fatigue. bilitation clinic. The two intervention groups chose a pre- Savard et al investigated the efficacy of CBT-I in a wait - ferred relaxation technique (progressive muscle relaxation or list-controlled trial of 57 women who had received treatment 67,68 autogenic training) and received three standardized psycho- for breast cancer. Outcomes included sleep quantity/ educational sessions that provided information about sleep quality (assessed with sleep diaries and polysomnography), 67 68 hygiene, stimulus control, and cognitive restructuring. Both psychological distress, and immune functioning. Pre- of the intervention groups showed durable improvements post program sleep diaries revealed significant reductions in sleep variables compared with the usual care comparison in sleep onset latency and time spent awake at night, and group. These results suggest that providing a modest sleep- improvements in sleep efficiency. These improvements were education intervention and relaxation training while patients mirrored on the polysomnography assessment of sleep. receive treatment may be an effective way to address acute Total sleep time steadily increased over the 12-month study insomnia and ward off future sleep disturbances; however, period, with participants averaging an additional 38 minutes submit your manuscript | www.dovepress.com Neuropsychiatric Disease and Treatment 2014:10 Dovepress Garland et al Dovepress submit your manuscript | www.dovepress.com Neuropsychiatric Disease and Treatment 2014:10 Dovepress Table 2 Controlled studies of cognitive behavioral therapy for insomnia (CBT-i) in cancer patients Study Year Sample/ Diagnosis/ Tx status Tx – treatment(s) Intervention Assessment Outcome Main results* sex stage C – control details times measures Savard 2005 57/females Breast/i–iii Posttreatment Tx – SC, SR, CR, Group T1 – week 0 SL, wASO, TST, SD: ↓ SL, wASO, ↑ Se, TST (all ,0.01) et al SH, fatigue and eight sessions T2 – week 8 Se (SD and PSG) PSG: ↓ SL (0.001), wASO (0.05), ↑ Se (0.05) stress management weekly T3 – week 20 iSi ↓ insomnia severity (,0.001) C – waitlist 90 minutes T4 – week 32 HADS, MFi, Significant ↓ depression (0.001), anxiety (0.001), T5 – week 52 QLQ-C30 fatigue (0.001) and ↑ quality of life (0.0001) Savard 2005 Blood-cell counts ↑ iFN-γ, iL1β, wBC, lymphocytes et al and cytokines epstein and 2007 72/females Breast/i–iii Posttreatment Tx – SC, SR, SH Group T1 – week 0 SL, wASO, TST, Both groups: Dirksen C – sleep education Six sessions T2 – week 6 Se (SD and SD: ↓ SL, wASO, ↑ Se, TST (all ,0.001) and hygiene weekly ×4, phone ×2 actigraphy) Actigraphy: ↓ SL (0.03), wASO (0.03), 30–120 minutes ↑ TST (0.02) espie 2008 150/males Mixed/no Posttreatment Tx – SC, SR, CR Group T1 – week 0 SL, wASO, SD: ↓ SL (∼16 min), wASO ( ∼38 min), et al and females active C – treatment Five sessions T2 – week 6 TST, Se (SD ↑ Se (∼10%), all ,0.001 disease as usual weekly T3 – week 30 and actigraphy) Actigraphy: significant ↓ at T2 but not T3 50 minutes HADS, FACT-G, Significant ↓ depression (0.004), anxiety (0.011), FSi fatigue (0.001) and ↑ quality of life (0.001) at T3 Berger 2009 219/females Breast/ Pre-, during, Tx – modified SC, individual T1 – pre-chemo SL, wASO, SD: ↓ wASO (0.03), ↑ Se (0.001) et al i–iiiA and post- modified SR, RT, SH Before, biweekly T2-T8 – during TST, Se (SD Actigraphy: significant ↓ wASO (0.03) chemo C – diet education during, 30 days chemo and actigraphy) ↓ sleep disturbance (0.05) after chemo T9 – 30 days PSQi Fatigue ↓ in both groups at T6 15–30 minutes post-Tx PFS Berger 2009 T1 – 30 days SL, wASO, No significant sleep diff between groups at T4 et al post-chemo TST, Se (SD Significant ↓ sleep disturbance (0.02) in Tx group T2 – 60 days and actigraphy) at T4 post-chemo PSQi Both groups significantly improved at T4 T3 – 90 days PFS, SeS, HADS, post-chemo MOS-SF-36 T4 – 1 year post-chemo Fiorentino 2010 14/females Breast/i–iii Posttreatment Tx – SR, SC, SH, individual T1 – week 0 SL, wASO, SD: ↓ wASO (0.002), ↑ Se (0.01), NwAK (0.02) et al RT, CR Six sessions T2 – week 6 TST, Se (SD Actigraphy: ↓ NwAK (0.05), wASO (0.009), C – waitlist weekly T3 – week 13 and actigraphy) ↑ TST (0.03), 60 minutes PSQi, iSi Significant ↓ insomnia severity (0.001), eS =10.4; ↓ sleep disturbance (0.002), eS =0.8 at T3 Ritterband 2012 28/males Mixed/no Posttreatment Tx – SR, SC, SH, CR, individual T1 – week 0 SD: SL, NwAK, ↓ SL (0.03), ↑ Se (0.01), et al and females active RP (internet based) Six sessions over T2 – week 10 wASO, TST, Se NwAK, wASO, TST (all ns) disease C – waitlist 9 weeks iSi Significant ↓ insomnia severity (0.01), eS =1.85 45–60 minutes HADS, MFSi, ↓ fatigue (0.01), no significant change in MOS-SF-12 depression, anxiety or quality of life Dovepress CBT for insomnia in cancer survivors of sleep per night by study completion. The proportion of individuals experiencing clinically significant change was 70% at 12-month follow-up. Study participation was also related to some alterations of immune function, as demon- strated by increases in cytokine secretion (interferon gamma and interleukin-1 beta); however, the clinical relevance of these changes remain unclear. Epstein and Dirksen examined the efficacy of a six- session CBT intervention for the treatment of insomnia in a sample of breast-cancer survivors. A total of 72 women were randomized to either CBT-I or a control group that also received sleep education and information on sleep hygiene. Both groups showed similar decreases in sleep onset latency, wake after sleep onset, and time in bed, and increases in total sleep time, sleep efc fi iency, and sleep quality after treatment. However, these results may underrepresent the effects of CBT-I given that the control group received recommenda- tions that overlapped with the CBT-I intervention – namely, to establish a regular wake time, reduce time spent in bed, and reserve time in the evening to relax. Regardless, the results suggest that addressing sleep disturbance, even at a low intensity, can produce meaningful improvements for individuals with cancer. Considering that insomnia symptoms tend to be exac- erbated during chemotherapy, Berger et al investigated whether sleep could be improved with an individualized sleep-promotion plan including the CBT-I components of stimulus control, sleep restriction, relaxation therapy, and sleep-hygiene counseling in a group of women undergoing 70,71 chemotherapy for breast cancer. The women were not required to have disturbed sleep upon enrolling in the trial, and the stimulus control and sleep restriction components were modified to be more lenient than would typically be recommended, because the authors felt this would be easier for participants to adhere to during treatment. Prior to beginning chemotherapy, 219 women were randomly assigned to the treatment group or a healthy-eating control condition. The individual plans were reviewed, revised, and reinforced during chemotherapy; at 30, 60, and 90 days after the last chemotherapy treatment; and at 1 year posttreatment. Between-group differences were observed for sleep quality and sleep efficiency, as well as a decrease in the number of awakenings and minutes awake after sleep onset at 30 days posttreatment. Only sleep quality, however, remained significantly improved at the 1-year follow-up. This study is novel in its demonstration that behavioral interventions for sleep can be successfully delivered during chemotherapy treatment. submit your manuscript | www.dovepress.com Neuropsychiatric Disease and Treatment 2014:10 Dovepress Garland 2014 111/males Mixed/no Posttreatment Tx1 – SR, SC, Group T1 – week 0 SL, wASO, TST, SD: Tx1 ↓ SL (0.004), ↑ Se (0.008) et al and females active SH, CR, RT, RP eight session T2 – week 8 Se (SD and Both groups: ↓ wASO (0.001) ↑ Se (0.001) disease Tx2 – MBSR weekly T3 – week 32 actigraphy) Actigraphy: SL (ns), ↓ wASO (0.001), ↑ TST, 90 minutes iSi, PSQi, DBAS Se (0.001) in both groups POMS-SF, CSOSi Tx1: significant ↓ insomnia severity, sleep disturbance, dysfunctional beliefs at T3 Both groups significant ↓ stress and mood symptoms Savard 2014 260/females Breast/i–iii Posttreatment Tx1 – SR, SC, CR, SH individual T1 – week 0 SL, wASO, SD: no diff between Tx1 and Tx2 on ↓ SL (0.13), et al (clinician delivered) Six session T2 – week 6 TST, Se (SD wASO (0.24), ↑ Se (0.13) Tx2 – SR, SC, CR, weekly and actigraphy) Actigraphy: TST increased in Tx1 only (0.04) SH (video based) 50–60 minutes iSi, DBAS Significant ↓ insomnia severity (0.03), C – treatment MFi, HADS, dysfunctional beliefs (for Tx1 only) as usual eORTC QLQ- Greater ↓ in fatigue, anxiety and depression in C30 Tx1. Quality of life ↑ in all three groups Note: *Group by time interactions are presented unless otherwise specified. Abbreviations: C, control; CR, cognitive restructuring; CSOSi, Calgary Symptoms of Stress inventory; DBAS, Dysfunctional Beliefs and Attitudes About Sleep; eORTC QLQ-C30, european Organization for Research and Treatment of Cancer Quality of Life Questionnaire; eS, effect size; FACT-G, Functional Assessment of Cancer Therapy – General; FSi, Fatigue Symptom inventory; HADS, Hospital Anxiety and Depression Scale; iFN-γ, interferon gamma; iL1β, interleukin-1-beta; iSi, insomnia Severity index; MBSR, mindfulness-based stress reduction; MFi, Multidimensional Fatigue inventory; MFSi, Multidimensional Fatigue Symptom inventory; MOS-SF-36, Medical Outcomes Study Short-Form General Health Survey; MOS-SF-12, Medical Outcomes Study Short-Form General Health Survey (Short version); NWAK, number of awakenings; PFS, Piper Fatigue Scale; POMS-SF, Profile of Mood States, Short Form; PSG, polysomnography; PSQI, Pittsburgh Sleep Quality Index; QLQ-C30, Quality of Life Questionnaire – Cancer; RP, relapse prevention; RT, relaxation training; SC, stimulus control; SE, sleep efficiency; SD, sleep diary; SES, Symptom experience Scale; SH, sleep hygiene; SL, sleep onset latency; SR, sleep restriction; T, time effect; TST, total sleep time; Tx, treatment; wASO, wake after sleep onset; wBC, white blood cells; chemo, chemotherapy; diff, difference; min, minutes; ns, non-significant; ↑, increase; ↓, decrease. Garland et al Dovepress Many CBT-I interventions for cancer patients are may not otherwise have access to professionally delivered delivered in group formats, making these a time and cost- treatment. effective treatment option; however, this format may not Considering the evidence for the efficacy of CBT-I in suit all patients or may not be available in all settings. cancer patients, research is moving toward comparative Hence, Fiorentino et al conducted a randomized controlled effectiveness trials. Garland et al conducted a randomized crossover pilot trial to determine the effects of a 6-week non-inferiority trial comparing CBT-I with Mindfulness- individual CBT-I program in 14 breast-cancer survivors. based Cancer Recovery (MBCR), an adaptation of Mindful- Patients reported improved insomnia symptom severity and ness Based Stress Reduction (MBSR) in a heterogeneous better sleep quality, and decreased total sleep time, wake sample of 111 posttreatment cancer patients. MBSR is an after sleep onset, and number of awakenings compared increasingly popular, evidence-based intervention designed 78–80 with waitlist control. Overall, insomnia was completely to reduce overall distress in cancer patients. Preliminary resolved in 43% of the participants and sleep disturbance evidence has shown that MBCR/MBSR participation is also was resolved in 71%, demonstrating the effectiveness of associated with improved sleep outcomes in cancer 81–83 this individual format. patients. Using a non-inferiority margin of four points on 73 84 Given the overall limited availability of CBT-I programs, the Insomnia Severity Index, MBCR demonstrated inferior- Ritterband et al examined whether an Internet-based CBT-I ity to CBT-I when assessed immediately after the program program could improve symptoms of insomnia in a sample but was within the non-inferiority margin at the 3-month of cancer survivors. A sample of 28 men and women were follow-up. For specic fi sleep variables, CBT-I produced larger randomized to either an Internet-based CBT-I intervention improvements in diary-measured sleep latency and sleep group or a waitlist control group. Participants in the inter- efficiency, but both interventions significantly reduced the vention group were given access to an online program called amount of time spent awake after sleep onset and increased “Sleep Healthy Using The Internet” (SHUTi) for 9 weeks. total sleep time. Significant improvements in symptoms of The SHUTi program includes sleep restriction, stimulus stress and psychological functioning were also reported, control, sleep hygiene, cognitive restructuring, and relapse regardless of assigned treatment. Considering that CBT-I was prevention. Compared with the control group, intervention associated with faster effects than MBCR, it remains the treat- participants demonstrated signic fi antly greater improvements ment of choice for most cancer patients with insomnia. With in insomnia severity, sleep efficiency, sleep onset latency, that in mind, however, MBCR/MBSR should be considered and sleep quality. The results of this study provide initial a viable alternative for patients who may be interested in an feasibility data for using Internet-based CBT-I as a method acceptance-based treatment approach. of improving the provision of evidence-based interventions for cancer survivors who may not have regular access to Discussion such programs. This article has reviewed the literature and examined Based on their promising preliminary data presented the efficacy of CBT-I in people diagnosed with cancer. earlier in this article, Savard et al conducted a three-armed trial Consistent with research in the broader population, CBT-I comparing video-based and professionally delivered CBT-I has been found to be associated with clinically and statisti- to a no-treatment control group in 242 women posttreat- cally significant improvements in subjective sleep outcomes ment for breast cancer. Both the video and professionally in patients with cancer. There is also some evidence to administered CBT-I groups were associated with sig- suggest that improving sleep may produce concomitant nificantly greater improvements in diary-measured sleep improvements in mood disturbance, cancer-related fatigue, variables compared with the control; however, the patients and overall quality of life. There were a variety of treatment in the professionally administered treatment group expe- modalities offered, including self-administration by video; rienced greater remission rates (71.3% versus 44.3%) and professional administration of CBT-I to individuals in per- reported larger improvements in overall insomnia severity, son, by telephone or over the Internet; and individual and dysfunctional sleep beliefs, fatigue, and depression levels group programs delivered face-to-face – all of which have than the video group. The findings of this study suggest the potential to increase patient access to evidence-based that while face-to-face administration may be optimal, treatment. Despite the encouraging findings of this review, video-based delivery can also produce clinically meaning- there are several limitations and identie fi d priorities for future ful improvements and increases options for patients who investigation. submit your manuscript | www.dovepress.com Neuropsychiatric Disease and Treatment 2014:10 Dovepress Dovepress CBT for insomnia in cancer survivors First, while several of the studies reviewed provide or with modifications – can be successfully delivered to support for the efficacy of face-to-face group-based CBT-I patients with aggressive, complex, or late-stage cancers, in interventions as a method of improving sleep in cancer order to expand treatment options for these often overlooked 91–93 survivors with insomnia, there is still an identified lack of populations. 73 64,76 access to such treatments. The studies by Savard et al and Ritterband et al highlight the potential for self-administered Conclusion and/or Internet-based interventions to fill in treatment gaps Insomnia has a profound impact on a cancer patient’s quality and target underserved populations, but larger implementa- of life and can add to the symptom burden already exacted by tion trials are needed. Future research should investigate the the disease. With the prevalence rates of insomnia higher in most effective methods for translating the current evidence cancer patients than in the general population, insomnia treat- for interventions like CBT-I into practice, and investigate ments that can be delivered in conjunction with traditional policy change to improve access and coverage for behavioral cancer treatments are necessary. The research examining sleep medicine services in cancer care. Considering that CBT-I in patients with cancer suggests that it is a generally insomnia in cancer patients is often chronic once it develops, acceptable treatment that is both efc fi acious and durable, both it is important to investigate the most appropriate screening, during and after cancer treatment. Future research in this area assessment, and intervention schedule to efficiently prevent should focus on expanding the populations of patients studied and treat insomnia in this group. and translating evidence into clinical practice. It remains a Second, although CBT-I has demonstrated eff icacy health care priority to expand available treatment options and in the cancer context, there is a significant proportion of increase awareness and access to CBT-I in cancer care. patients who do not consistently adhere to the treatment recommendations. Given that greater adherence to pre- Disclosure scribed treatment regimens (eg, prescribed wake times) The authors declare no conflicts of interest in this work. is associated with greater improvements in sleep, future research should investigate the potential of motivational References enhancement techniques to improve compliance and hence 1. Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006;3(11):e442. response and remittance rates. Patient preference is another 2. American Cancer Society. Global Cancer Facts and Figures. particularly important contributor to patient adherence 2nd ed. Atlanta, GA: American Cancer Society; 2011. Available and outcomes for behavioral interventions like CBT-I, from: http://www.cancer.org/Research/CancerFactsFigures/ GlobalCancerFactsFigures/global-cancer-facts-fig ures-2nd-edition. which require a significant investment of time and active pdf. Accessed April 2, 2014. participation. 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Sleeping well with cancer: a systematic review of cognitive behavioral therapy for insomnia in cancer patients

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Abstract

Neuropsychiatric Disease and Treatment Dovepress open access to scientific and medical research Open Access Full Text Article Review Sleeping well with cancer: a systematic review of cognitive behavioral therapy for insomnia in cancer patients Sheila N Garland Abstract: Individuals with cancer are disproportionately affected by sleep disturbance and insomnia relative to the general population. These problems can be a consequence of the Jillian A Johnson psychological, behavioral, and physical effects of a cancer diagnosis and treatment. Insomnia Josee Savard 4 often persists for years and, when combined with already high levels of cancer-related distress, Philip Gehrman may place cancer survivors at a higher risk of future physical and mental health problems and Michael Perlis poorer quality of life. The recommended first-line treatment for insomnia is cognitive behavioral Linda Carlson therapy for insomnia (CBT-I), a non-pharmacological treatment that incorporates cognitive and Tavis Campbell behavior-change techniques and targets dysfunctional attitudes, beliefs, and habits involving Department of Family Medicine sleep. This article presents a comprehensive review of the literature examining the efficacy of and Community Health, University CBT-I on sleep and psychological outcomes in cancer patients and survivors. The search revealed of Pennsylvania, Philadelphia, PA, USA; Department of Psychology, 12 studies (four uncontrolled, eight controlled) that evaluated the effects of CBT-I in cancer University of Calgary, Calgary, AB, patients or survivors. Results suggest that CBT-I is associated with statistically and clinically Canada; School of Psychology, Laval significant improvements in subjective sleep outcomes in patients with cancer. CBT-I may also University, Quebec City, QC, Canada; Department of Psychiatry, University improve mood, fatigue, and overall quality of life, and can be successfully delivered through of Pennsylvania, Philadelphia, PA, USA; a variety of treatment modalities, making it possible to reach a broader range of patients who Department of Oncology, University may not have access to more traditional programs. Future research in this area should focus on of Calgary, Calgary, AB, Canada the translation of evidence into clinical practice in order to increase awareness and access to effective insomnia treatment in cancer care. Keywords: CBT-I, cancer, insomnia, sleep, systematic review, quality of life, survivors Background Prevalence of sleep disturbances and insomnia in cancer Cancer is one of the leading causes of global morbidity and mortality, second only to heart disease. The global burden of cancer is expected to reach 21.4 million individu- als by 2030. Since the early 1990s, early detection and improved treatment methods have led to an overall reduction in cancer death rates and the prevention of approxi- mately 1,024,400 cancer deaths. Improved survival rates mean that more people will require ongoing treatment for the persistent physical and psychological side effects of a cancer diagnosis. An important but often overlooked side effect of cancer diagnosis 4–7 and treatment is sleep disturbance and insomnia. Prevalence rates for insomnia in individuals with cancer range from 30% to 60%, depending on the definition, time of 8–10 assessment, and measurement tool used. According to the most recent Diagnostic Correspondence: Tavis Campbell Department of Psychology, University and Statistical Manual of Mental Disorders, fifth edition, nosology, “insomnia” is of Calgary, 2500 University Drive Nw, defined as dissatisfaction with sleep quality or quantity characterized by difficulty Calgary, AB, T2N 1N4, Canada email t.s.campbell@ucalgary.ca initiating sleep, maintaining sleep, or early morning awakenings that cause significant submit your manuscript | www.dovepress.com Neuropsychiatric Disease and Treatment 2014:10 1113–1124 Dovepress © 2014 Garland et al. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License. The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further http://dx.doi.org/10.2147/NDT.S47790 permission from Dove Medical Press Limited, provided the work is properly attributed. Permissions beyond the scope of the License are administered by Dove Medical Press Limited. Information on how to request permission may be found at: http://www.dovepress.com/permissions.php Garland et al Dovepress distress or impairment in daytime functioning and occur experience sleep difficulty than those without pain, whereas at least three nights per week for at least 3 months despite people with higher levels of emotional distress were 4.5 times adequate opportunity for sleep. The presence of persistent more likely to report problems with sleep than those with low insomnia places patients at a higher risk for psychological distress levels. Considering that sleep disturbance co-occurs 12,13 and physical morbidity and reduced quality of life. with, and significantly contributes to, other cancer-related symptoms, it may be important for interventions to address Chemotherapy as a contributor symptom clusters or to focus on the symptom most associated to disturbed sleep and insomnia with the other conditions. The greater rate of insomnia experienced by cancer patients Disturbed sleep, insomnia, has not only been attributed to the emotional consequences of being diagnosed with cancer but also to the direct effects and quality of life of cancer treatments and their side effects, particularly Not only are cancer-related sleep disturbances widespread – 7,14–16 chemotherapy. In a prospective study of 823 patients representing a major concern for people irrespective of their undergoing chemotherapy, 39.8% reported moderate or stage in the cancer trajectory – they can also negatively severe insomnia symptoms after their first chemotherapy impact overall quality of life and cancer-therapy outcomes. treatment, with symptoms persisting throughout subsequent The relationship between insomnia and quality of life was cycles in two-thirds of patients. A systematic review of 21 explored in a cross-sectional analysis of 954 people with a articles further suggested that sleep disturbances can persist variety of cancer diagnoses. Regardless of age and treat- for up to 1 year post-chemotherapy. The most commonly ment status, higher self-reported insomnia symptoms were reported sleep problem by patients undergoing chemotherapy associated with lower overall quality of life, with particularly is the inability to maintain sleep (63.3%), with disruptions strong associations with poorer subjective health/physical and being attributed to the anxiety and worry related to the cancer psychological/spiritual well-being. Although not conclusive, diagnosis/treatments and the effects of cancer treatments there is also evidence that impaired sleep can have a negative themselves (ie, postsurgical pain/discomfort, overall fatigue, impact on objective health outcomes. Mormont et al reported nausea, nocturnal hot flashes, increased bathroom use, and that metastatic colorectal cancer patients with dysregulated 18–20 steroid-induced agitation). As such, it appears that can- sleep/wake patterns (ie, poorly differentiated activity levels cer treatments, particularly chemotherapy and surgery, may during wake and sleep) were five times more likely to die contribute to an increased risk for developing clinically within 5 years than patients with a more distinguishable cir- significant sleep disturbances and partially account for the cadian rhythm. When assessed using actigraphy, people with higher than average prevalence rates demonstrated in this a dampened circadian rhythm, characterized by flat profiles population. with less activity during the day and more activity during the night, reported more depressive symptoms and worse Disturbed sleep, insomnia, overall quality of life than those with more robust circadian and other cancer consequences rhythms. Together, these studies suggest that the mainte- Sleep disturbances and insomnia frequently co-occur in nance of robust circadian rhythms and consistent and distin- symptom clusters with other commonly reported cancer side guishable sleep and wake patterns have the potential to reduce effects, such as pain, fatigue, psychological distress, and depressive symptomatology, improve overall perception of 21–23 depression. Although the mechanisms involved are not quality of life, and potentially translate into better physical completely understood, the presence of symptom comorbid- outcomes and survival. Although the directionality of these ity in cancer patients might relate to underlying ina fl mmatory effects is not clear, it is possible that intervening anywhere processes common to many of these concerns. This may in the cycle (eg, targeting sleep) may subsequently positively partially explain why these symptoms have demonstrated effect other symptoms and longer-term outcomes. both indirect and direct reciprocal effects; that is, the presence Cognitive behavioral therapy of one influences the incidence and severity of the others. A recent study investigated the relationship between sleep for insomnia (CBT-i) difficulty, self-reported pain, and emotional distress in a Compared with good sleepers, individuals with insom- sample of 2,862 cancer outpatients. Individuals reporting n i a ex h i b i t c og n i t ive , p hy s i o l og i c a l , a n d c o r t i c a l 29,30 clinically significant pain were 2.7 times more likely to hyperarousal; demonstrate particular cognitive patterns submit your manuscript | www.dovepress.com Neuropsychiatric Disease and Treatment 2014:10 Dovepress Dovepress CBT for insomnia in cancer survivors 31,32 and attentional biases; and strongly endorse problematic insomnia comorbid with psychiatric or medical disorders is 33,34 sleep-related beliefs. Cognitive behavioral therapy for as responsive, if not more so, to CBT-I than so-called primary 52,59 insomnia (CBT-I) is a multicomponent intervention devel- insomnia. Several of these trials have also shown that oped to address these interrelated components. Essentially, CBT-I also produces improvements in the comorbid condi- CBT-I has five potential components: sleep restriction, tion. For example, in the context of major depression, CBT-I stimulus control, sleep hygiene, cognitive restructuring, and nearly doubles response and remission rates when added to 35 60 relaxation training. Most modern studies of CBT-I include standard antidepressant therapies. sleep restriction and stimulus control. “Sleep restriction” CBT-I in the context of cancer is thought to be particu- addresses what is believed to be the primary perpetuating larly challenging because of the overlap and chronicity of factor for chronic insomnia – the mismatch between sleep cancer-related side effects that may influence the develop - opportunity and sleep ability. “Stimulus control” targets ment, severity, and persistence of insomnia symptoms. The stimulus “dyscontrol” (the occurrence of a diversity of purpose of the present report is to summarize the effect of non-sleep behaviors in the bedroom) and sets the stage CBT-I in cancer patients and present recommendations for for counterconditioning (ie, the reconditioning of sleep- future research. related stimuli to elicit the physiology of sleep as opposed Methods to the physiology of wakefulness). “Sleep hygiene”, while An independent review of the literature was performed ineffective as a monotherapy, serves to promote behaviors separately by the first and second authors using PubMed, and practices that facilitate sleep and to discourage those MEDLINE , and PsycINFO databases from the earliest that are thought to contribute to insomnia. “Cognitive date available until January 2014. Only studies published restructuring” is used to identify and address thoughts in English were eligible for review. Search terms included and beliefs that may contribute to the development of, or “cancer/neoplasms”, “insomnia”, “cognitive”, “behavioral”, reinforce, behaviors that produce pre-sleep arousal and/ “cognitive behavioral therapy”, “cognitive therapy”, “behav- or performance anxiety. Relaxation training (the original ioral therapy”, “CBT-I”, “CBT”, “treatment”, “intervention”, behavioral intervention for insomnia) is no longer regu- and “sleep disturbances”. Reference lists of the retrieved larly incorporated into CBT-I but is sometimes utilized to articles were reviewed and articles in press were identie fi d by reduce peripheral autonomic arousal and facilitate mental contacting the authors directly. An article was included if it de-arousal. met the following three criteria: 1) cognitive behavior therapy or behavior therapy tailored for insomnia was used as the Evidence for the overall efficacy of CBT-I primary treatment, 2) the target population were people diag- CBT-I, with or without relaxation therapy, is recommended nosed with cancer (either undergoing or having completed by the American Association of Sleep Medicine, is con- primary treatment), and 3) a subjective or objective measure sidered a well-established intervention by the American of sleep was included as a treatment outcome. Once the Psychiatric Association, and has demonstrated efficacy for 40,41 independent search results were compared, any discrepancies treating primary insomnia. In non-cancer groups, CBT-I were resolved through consultation with the final author and has produced larger effects than treatment as usual (TAU), 43,44 consensus was achieved. A total of 12 intervention studies waitlist control groups, pharmacotherapy +/– medication 45–49 50,51 met the inclusion criteria: four were quasi-experimental placebo, relaxation therapy and behavioral placebo, studies (ie, no random assignment to treatment or a control and sleep-hygiene education. Of the studies with long-term condition) and eight were randomized controlled trials follow-ups, the effects of CBT-I have been remarkably dura- (RCTs). We did not identify any articles of CBT-I in cancer ble (up to 2 years time) in a substantial proportion of partici- patients published in non-English journals. pants, and, on several measures, patients continue to improve (if not reach remission) long after treatment is discontinued. Results While most of the treatment evaluation investigations utilize Quasi-experimental studies a form of CBT-I that is in person, one-on-one, and extends over five to ten sessions, there is evidence that CBT-I can of CBT-i in cancer patients 54,55 56 be successfully delivered to groups, by telephone, over Four uncontrolled studies investigating CBT-I in cancer 57 58 the Internet, and with self-help manuals. Finally, there is patients were identified for inclusion ( Table 1). All of these an emerging literature providing clear demonstrations that studies were conducted with non-metastatic cancer patients submit your manuscript | www.dovepress.com Neuropsychiatric Disease and Treatment 2014:10 Dovepress Garland et al Dovepress submit your manuscript | www.dovepress.com Neuropsychiatric Disease and Treatment 2014:10 Dovepress Table 1 Uncontrolled trials of cognitive behavioral therapy for insomnia (CBT-i) in cancer patients Study Year Sample/ Diagnosis/ Tx status Design Assessment Tx description Intervention Outcome Main results sex stage times details measures Davidson 2001 12/males Mixed/no Posttreatment Single group T1 – week 0 SC, RT, SH, CR Group SD: SL, NwAK, ↓ NwAK (0.002), wASO (0.001) et al and females active T2 – week 4 Six session wASO, TST, Se ↑ TST (0.03), Se (,0.001) disease T3 – week 8 weekly ×5, then Sii ↓ sleep-related impairment (,0.001) monthly ×1 HADS, QLQ-C30 No significant ↓ in depression, 60–90 minutes anxiety or ↑ quality of life at T3 Quesnel 2003 10/females Breast/i–iii Posttreatment Multiple- T1 – week 0 SC, SR, CR, SH fatigue Group wASO, TST (PSG) PSG: ↓ wASO (0.02); ↑ Se (0.04) et al baseline T2 – week 8 management, RP eight session iSi 86% clinically significant ↓ in iSi at T3 Single subject T3 – week 32 weekly BDi, STAi, MFi, No significant ↓ in depression, anxiety, 90 minutes QLQ-C30 fatigue or ↑ quality of life at T3 Simeit 2004 229/males Mixed/no Posttreatment Three group T1 – week 0 Patients chose PMR Group PSQi Both Tx groups: et al and females active (PMR, AT, T2 – week 4 or AT. Tx groups Three session QLQ-C30 ↓ SL (,0.001), sleep disturbance disease or UC) T3 – week 10 were provided with weekly (,0.001) T4 – week 34 information on SC, SR, 60 minutes ↑ sleep duration (,0.001), Se (,0.001), CR, SH (not formal sleep quality (,0.001), daytime function CBT-i) (,0.001) All groups ↑ quality of life at T4 Savard 2011 11/females Breast/i–iii Post-radiation Single group T1 – week 0 SC, SR, CR, SH, RP Self-administered SD: SL, wASO, ↓ SL (0.01), wASO ( ,0.001) et al T2 – week 6 DvD/booklet TST, Se ↑ Se (,0.001), TST (ns) T3 – week 18 Six modules iSi ↓ insomnia severity (,0.001) weekly HADS, MFi, Significant ↓ depression (0.03), 60 minutes QLQ-C30, DBAS dysfunctional beliefs (0.001) and ↑ quality of life (0.03). No significant ↓ anxiety or fatigue at T3 Abbreviations: AT, autogenic training; BDi, Beck Depression inventory; CR, cognitive restructuring; DBAS, Dysfunctional Beliefs and Attitudes about Sleep; HADS, Hospital Anxiety and Depression Scale; iSi, insomnia Severity index; MFi, Multidimensional Fatigue inventory; NwAK, number of awakenings; PMR, progressive muscle relaxation; PSG, polysomnography; PSQi, Pittsburgh Sleep Quality index; QLQ-C30, Quality of Life Questionnaire – Cancer; RP, relapse prevention; RT, relaxation training; SC, stimulus control; SE, sleep efficiency; SD, sleep diary; SH, sleep hygiene; SII, Sleep Impairment Index; SL, sleep latency; SR, sleep restriction; STAI, State-Trait Anxiety Inventory; TST, total sleep time; Tx, treatment; UC, usual care; WASO, wake after sleep onset; ns, non-significant; ↑, increase; ↓, decrease. Dovepress CBT for insomnia in cancer survivors (50% breast and 50% mixed diagnoses) who were post- den fi itive prevention trials are required to adequately address treatment. Davidson et al published the first pre-post study this possibility. of a 6-week non-pharmacological sleep therapy program Controlled studies of CBT-i using CBT-I components (stimulus control, relaxation, “worry time”, and sleep hygiene) to improve sleep quality in cancer patients of a heterogeneous group of 12 breast-cancer patients with Eight RCTs of CBT-I in cancer patients were available for insomnia. Pre- to posttreatment effect sizes ranged from review. Two of these trials are reported in separate publica- 0.58 for total sleep time to 2.0 for sleep efficiency, indicat - tions, bringing the number of papers to ten (Table 2). Five ing a statistically and clinically significant improvement in of these studies were conducted in samples of women with patient functioning. Quesnel et al were the next to investigate breast cancer and the remaining three included men and a CBT-I intervention in a sample of ten women with breast women with mixed cancer diagnoses. The majority of studies cancer in a multiple-baseline design. At the end of the (80%) were conducted with patients who had completed treat- study, 50% of the participants met the classification cutoff ment. Half of the studies consisted of in-person group-based for “good sleepers”, designated as 85% sleep efficiency. interventions while the other half were individual-based This percentage increased to 71% at the 6-month follow-up. interventions, of which one delivered CBT-I to individuals Although both of these studies were limited by small sample via the Internet. The intervention length ranged from 5 to 9 sizes and no comparison groups, they provided impetus for weeks, and observed effects tended to be larger in studies larger efficacy trials. that used waitlist or TAU groups rather than attention control In-person psychological therapies, like CBT-I, may groups. Two studies compared CBT-I with another active not always be readily accessible, especially within cancer treatment group. care. Hence, Savard et al investigated the feasibility of The largest trial to date of standard CBT-I for insomnia self-administering CBT-I via 6-weekly DVD/booklets in in cancer was conducted in 2008 by Espie et al. This eleven women with breast cancer. The treatment consisted study assigned 150 heterogeneous posttreatment cancer of standard CBT-I components and was designed to match patients to either a 5-week CBT-I intervention or TAU. what would be delivered via face-to-face treatment. Insomnia The TAU group was intended to represent normal clinical severity and all sleep-diary variables (except total sleep time) practice, whereby physicians were free to offer appoint- demonstrated significant improvements at posttreatment, ments and prescribe sedative medications. Statistically and and these gains were maintained at the 3-month follow-up. clinically significant improvements in subjective measures This preliminary study was followed by a three-arm RCT of sleep were demonstrated for sleep onset latency, wake comparing video-delivered and professionally administered after sleep onset, and sleep efficiency in the CBT-I group, CBT-I to a no-treatment control group; the results of this are with large between-group effect sizes of –0.86, –0.97, and described in the next section. 1.09, respectively. These results translated into a reduction While CBT-I has largely been standardized in its delivery, of approximately 1 hour in sleep onset latency and time important questions remain about the adequate “dose” or nec- spent awake during the night compared with no change essary delivery required to produce treatment effects. Simeit in the TAU group. These improvements in sleep outcomes et al incorporated components of CBT-I into a multimodal were significantly related to increased quality of life and psychological intervention for 229 inpatients at a cancer reha- reduced daytime fatigue. bilitation clinic. The two intervention groups chose a pre- Savard et al investigated the efficacy of CBT-I in a wait - ferred relaxation technique (progressive muscle relaxation or list-controlled trial of 57 women who had received treatment 67,68 autogenic training) and received three standardized psycho- for breast cancer. Outcomes included sleep quantity/ educational sessions that provided information about sleep quality (assessed with sleep diaries and polysomnography), 67 68 hygiene, stimulus control, and cognitive restructuring. Both psychological distress, and immune functioning. Pre- of the intervention groups showed durable improvements post program sleep diaries revealed significant reductions in sleep variables compared with the usual care comparison in sleep onset latency and time spent awake at night, and group. These results suggest that providing a modest sleep- improvements in sleep efficiency. These improvements were education intervention and relaxation training while patients mirrored on the polysomnography assessment of sleep. receive treatment may be an effective way to address acute Total sleep time steadily increased over the 12-month study insomnia and ward off future sleep disturbances; however, period, with participants averaging an additional 38 minutes submit your manuscript | www.dovepress.com Neuropsychiatric Disease and Treatment 2014:10 Dovepress Garland et al Dovepress submit your manuscript | www.dovepress.com Neuropsychiatric Disease and Treatment 2014:10 Dovepress Table 2 Controlled studies of cognitive behavioral therapy for insomnia (CBT-i) in cancer patients Study Year Sample/ Diagnosis/ Tx status Tx – treatment(s) Intervention Assessment Outcome Main results* sex stage C – control details times measures Savard 2005 57/females Breast/i–iii Posttreatment Tx – SC, SR, CR, Group T1 – week 0 SL, wASO, TST, SD: ↓ SL, wASO, ↑ Se, TST (all ,0.01) et al SH, fatigue and eight sessions T2 – week 8 Se (SD and PSG) PSG: ↓ SL (0.001), wASO (0.05), ↑ Se (0.05) stress management weekly T3 – week 20 iSi ↓ insomnia severity (,0.001) C – waitlist 90 minutes T4 – week 32 HADS, MFi, Significant ↓ depression (0.001), anxiety (0.001), T5 – week 52 QLQ-C30 fatigue (0.001) and ↑ quality of life (0.0001) Savard 2005 Blood-cell counts ↑ iFN-γ, iL1β, wBC, lymphocytes et al and cytokines epstein and 2007 72/females Breast/i–iii Posttreatment Tx – SC, SR, SH Group T1 – week 0 SL, wASO, TST, Both groups: Dirksen C – sleep education Six sessions T2 – week 6 Se (SD and SD: ↓ SL, wASO, ↑ Se, TST (all ,0.001) and hygiene weekly ×4, phone ×2 actigraphy) Actigraphy: ↓ SL (0.03), wASO (0.03), 30–120 minutes ↑ TST (0.02) espie 2008 150/males Mixed/no Posttreatment Tx – SC, SR, CR Group T1 – week 0 SL, wASO, SD: ↓ SL (∼16 min), wASO ( ∼38 min), et al and females active C – treatment Five sessions T2 – week 6 TST, Se (SD ↑ Se (∼10%), all ,0.001 disease as usual weekly T3 – week 30 and actigraphy) Actigraphy: significant ↓ at T2 but not T3 50 minutes HADS, FACT-G, Significant ↓ depression (0.004), anxiety (0.011), FSi fatigue (0.001) and ↑ quality of life (0.001) at T3 Berger 2009 219/females Breast/ Pre-, during, Tx – modified SC, individual T1 – pre-chemo SL, wASO, SD: ↓ wASO (0.03), ↑ Se (0.001) et al i–iiiA and post- modified SR, RT, SH Before, biweekly T2-T8 – during TST, Se (SD Actigraphy: significant ↓ wASO (0.03) chemo C – diet education during, 30 days chemo and actigraphy) ↓ sleep disturbance (0.05) after chemo T9 – 30 days PSQi Fatigue ↓ in both groups at T6 15–30 minutes post-Tx PFS Berger 2009 T1 – 30 days SL, wASO, No significant sleep diff between groups at T4 et al post-chemo TST, Se (SD Significant ↓ sleep disturbance (0.02) in Tx group T2 – 60 days and actigraphy) at T4 post-chemo PSQi Both groups significantly improved at T4 T3 – 90 days PFS, SeS, HADS, post-chemo MOS-SF-36 T4 – 1 year post-chemo Fiorentino 2010 14/females Breast/i–iii Posttreatment Tx – SR, SC, SH, individual T1 – week 0 SL, wASO, SD: ↓ wASO (0.002), ↑ Se (0.01), NwAK (0.02) et al RT, CR Six sessions T2 – week 6 TST, Se (SD Actigraphy: ↓ NwAK (0.05), wASO (0.009), C – waitlist weekly T3 – week 13 and actigraphy) ↑ TST (0.03), 60 minutes PSQi, iSi Significant ↓ insomnia severity (0.001), eS =10.4; ↓ sleep disturbance (0.002), eS =0.8 at T3 Ritterband 2012 28/males Mixed/no Posttreatment Tx – SR, SC, SH, CR, individual T1 – week 0 SD: SL, NwAK, ↓ SL (0.03), ↑ Se (0.01), et al and females active RP (internet based) Six sessions over T2 – week 10 wASO, TST, Se NwAK, wASO, TST (all ns) disease C – waitlist 9 weeks iSi Significant ↓ insomnia severity (0.01), eS =1.85 45–60 minutes HADS, MFSi, ↓ fatigue (0.01), no significant change in MOS-SF-12 depression, anxiety or quality of life Dovepress CBT for insomnia in cancer survivors of sleep per night by study completion. The proportion of individuals experiencing clinically significant change was 70% at 12-month follow-up. Study participation was also related to some alterations of immune function, as demon- strated by increases in cytokine secretion (interferon gamma and interleukin-1 beta); however, the clinical relevance of these changes remain unclear. Epstein and Dirksen examined the efficacy of a six- session CBT intervention for the treatment of insomnia in a sample of breast-cancer survivors. A total of 72 women were randomized to either CBT-I or a control group that also received sleep education and information on sleep hygiene. Both groups showed similar decreases in sleep onset latency, wake after sleep onset, and time in bed, and increases in total sleep time, sleep efc fi iency, and sleep quality after treatment. However, these results may underrepresent the effects of CBT-I given that the control group received recommenda- tions that overlapped with the CBT-I intervention – namely, to establish a regular wake time, reduce time spent in bed, and reserve time in the evening to relax. Regardless, the results suggest that addressing sleep disturbance, even at a low intensity, can produce meaningful improvements for individuals with cancer. Considering that insomnia symptoms tend to be exac- erbated during chemotherapy, Berger et al investigated whether sleep could be improved with an individualized sleep-promotion plan including the CBT-I components of stimulus control, sleep restriction, relaxation therapy, and sleep-hygiene counseling in a group of women undergoing 70,71 chemotherapy for breast cancer. The women were not required to have disturbed sleep upon enrolling in the trial, and the stimulus control and sleep restriction components were modified to be more lenient than would typically be recommended, because the authors felt this would be easier for participants to adhere to during treatment. Prior to beginning chemotherapy, 219 women were randomly assigned to the treatment group or a healthy-eating control condition. The individual plans were reviewed, revised, and reinforced during chemotherapy; at 30, 60, and 90 days after the last chemotherapy treatment; and at 1 year posttreatment. Between-group differences were observed for sleep quality and sleep efficiency, as well as a decrease in the number of awakenings and minutes awake after sleep onset at 30 days posttreatment. Only sleep quality, however, remained significantly improved at the 1-year follow-up. This study is novel in its demonstration that behavioral interventions for sleep can be successfully delivered during chemotherapy treatment. submit your manuscript | www.dovepress.com Neuropsychiatric Disease and Treatment 2014:10 Dovepress Garland 2014 111/males Mixed/no Posttreatment Tx1 – SR, SC, Group T1 – week 0 SL, wASO, TST, SD: Tx1 ↓ SL (0.004), ↑ Se (0.008) et al and females active SH, CR, RT, RP eight session T2 – week 8 Se (SD and Both groups: ↓ wASO (0.001) ↑ Se (0.001) disease Tx2 – MBSR weekly T3 – week 32 actigraphy) Actigraphy: SL (ns), ↓ wASO (0.001), ↑ TST, 90 minutes iSi, PSQi, DBAS Se (0.001) in both groups POMS-SF, CSOSi Tx1: significant ↓ insomnia severity, sleep disturbance, dysfunctional beliefs at T3 Both groups significant ↓ stress and mood symptoms Savard 2014 260/females Breast/i–iii Posttreatment Tx1 – SR, SC, CR, SH individual T1 – week 0 SL, wASO, SD: no diff between Tx1 and Tx2 on ↓ SL (0.13), et al (clinician delivered) Six session T2 – week 6 TST, Se (SD wASO (0.24), ↑ Se (0.13) Tx2 – SR, SC, CR, weekly and actigraphy) Actigraphy: TST increased in Tx1 only (0.04) SH (video based) 50–60 minutes iSi, DBAS Significant ↓ insomnia severity (0.03), C – treatment MFi, HADS, dysfunctional beliefs (for Tx1 only) as usual eORTC QLQ- Greater ↓ in fatigue, anxiety and depression in C30 Tx1. Quality of life ↑ in all three groups Note: *Group by time interactions are presented unless otherwise specified. Abbreviations: C, control; CR, cognitive restructuring; CSOSi, Calgary Symptoms of Stress inventory; DBAS, Dysfunctional Beliefs and Attitudes About Sleep; eORTC QLQ-C30, european Organization for Research and Treatment of Cancer Quality of Life Questionnaire; eS, effect size; FACT-G, Functional Assessment of Cancer Therapy – General; FSi, Fatigue Symptom inventory; HADS, Hospital Anxiety and Depression Scale; iFN-γ, interferon gamma; iL1β, interleukin-1-beta; iSi, insomnia Severity index; MBSR, mindfulness-based stress reduction; MFi, Multidimensional Fatigue inventory; MFSi, Multidimensional Fatigue Symptom inventory; MOS-SF-36, Medical Outcomes Study Short-Form General Health Survey; MOS-SF-12, Medical Outcomes Study Short-Form General Health Survey (Short version); NWAK, number of awakenings; PFS, Piper Fatigue Scale; POMS-SF, Profile of Mood States, Short Form; PSG, polysomnography; PSQI, Pittsburgh Sleep Quality Index; QLQ-C30, Quality of Life Questionnaire – Cancer; RP, relapse prevention; RT, relaxation training; SC, stimulus control; SE, sleep efficiency; SD, sleep diary; SES, Symptom experience Scale; SH, sleep hygiene; SL, sleep onset latency; SR, sleep restriction; T, time effect; TST, total sleep time; Tx, treatment; wASO, wake after sleep onset; wBC, white blood cells; chemo, chemotherapy; diff, difference; min, minutes; ns, non-significant; ↑, increase; ↓, decrease. Garland et al Dovepress Many CBT-I interventions for cancer patients are may not otherwise have access to professionally delivered delivered in group formats, making these a time and cost- treatment. effective treatment option; however, this format may not Considering the evidence for the efficacy of CBT-I in suit all patients or may not be available in all settings. cancer patients, research is moving toward comparative Hence, Fiorentino et al conducted a randomized controlled effectiveness trials. Garland et al conducted a randomized crossover pilot trial to determine the effects of a 6-week non-inferiority trial comparing CBT-I with Mindfulness- individual CBT-I program in 14 breast-cancer survivors. based Cancer Recovery (MBCR), an adaptation of Mindful- Patients reported improved insomnia symptom severity and ness Based Stress Reduction (MBSR) in a heterogeneous better sleep quality, and decreased total sleep time, wake sample of 111 posttreatment cancer patients. MBSR is an after sleep onset, and number of awakenings compared increasingly popular, evidence-based intervention designed 78–80 with waitlist control. Overall, insomnia was completely to reduce overall distress in cancer patients. Preliminary resolved in 43% of the participants and sleep disturbance evidence has shown that MBCR/MBSR participation is also was resolved in 71%, demonstrating the effectiveness of associated with improved sleep outcomes in cancer 81–83 this individual format. patients. Using a non-inferiority margin of four points on 73 84 Given the overall limited availability of CBT-I programs, the Insomnia Severity Index, MBCR demonstrated inferior- Ritterband et al examined whether an Internet-based CBT-I ity to CBT-I when assessed immediately after the program program could improve symptoms of insomnia in a sample but was within the non-inferiority margin at the 3-month of cancer survivors. A sample of 28 men and women were follow-up. For specic fi sleep variables, CBT-I produced larger randomized to either an Internet-based CBT-I intervention improvements in diary-measured sleep latency and sleep group or a waitlist control group. Participants in the inter- efficiency, but both interventions significantly reduced the vention group were given access to an online program called amount of time spent awake after sleep onset and increased “Sleep Healthy Using The Internet” (SHUTi) for 9 weeks. total sleep time. Significant improvements in symptoms of The SHUTi program includes sleep restriction, stimulus stress and psychological functioning were also reported, control, sleep hygiene, cognitive restructuring, and relapse regardless of assigned treatment. Considering that CBT-I was prevention. Compared with the control group, intervention associated with faster effects than MBCR, it remains the treat- participants demonstrated signic fi antly greater improvements ment of choice for most cancer patients with insomnia. With in insomnia severity, sleep efficiency, sleep onset latency, that in mind, however, MBCR/MBSR should be considered and sleep quality. The results of this study provide initial a viable alternative for patients who may be interested in an feasibility data for using Internet-based CBT-I as a method acceptance-based treatment approach. of improving the provision of evidence-based interventions for cancer survivors who may not have regular access to Discussion such programs. This article has reviewed the literature and examined Based on their promising preliminary data presented the efficacy of CBT-I in people diagnosed with cancer. earlier in this article, Savard et al conducted a three-armed trial Consistent with research in the broader population, CBT-I comparing video-based and professionally delivered CBT-I has been found to be associated with clinically and statisti- to a no-treatment control group in 242 women posttreat- cally significant improvements in subjective sleep outcomes ment for breast cancer. Both the video and professionally in patients with cancer. There is also some evidence to administered CBT-I groups were associated with sig- suggest that improving sleep may produce concomitant nificantly greater improvements in diary-measured sleep improvements in mood disturbance, cancer-related fatigue, variables compared with the control; however, the patients and overall quality of life. There were a variety of treatment in the professionally administered treatment group expe- modalities offered, including self-administration by video; rienced greater remission rates (71.3% versus 44.3%) and professional administration of CBT-I to individuals in per- reported larger improvements in overall insomnia severity, son, by telephone or over the Internet; and individual and dysfunctional sleep beliefs, fatigue, and depression levels group programs delivered face-to-face – all of which have than the video group. The findings of this study suggest the potential to increase patient access to evidence-based that while face-to-face administration may be optimal, treatment. Despite the encouraging findings of this review, video-based delivery can also produce clinically meaning- there are several limitations and identie fi d priorities for future ful improvements and increases options for patients who investigation. submit your manuscript | www.dovepress.com Neuropsychiatric Disease and Treatment 2014:10 Dovepress Dovepress CBT for insomnia in cancer survivors First, while several of the studies reviewed provide or with modifications – can be successfully delivered to support for the efficacy of face-to-face group-based CBT-I patients with aggressive, complex, or late-stage cancers, in interventions as a method of improving sleep in cancer order to expand treatment options for these often overlooked 91–93 survivors with insomnia, there is still an identified lack of populations. 73 64,76 access to such treatments. The studies by Savard et al and Ritterband et al highlight the potential for self-administered Conclusion and/or Internet-based interventions to fill in treatment gaps Insomnia has a profound impact on a cancer patient’s quality and target underserved populations, but larger implementa- of life and can add to the symptom burden already exacted by tion trials are needed. Future research should investigate the the disease. With the prevalence rates of insomnia higher in most effective methods for translating the current evidence cancer patients than in the general population, insomnia treat- for interventions like CBT-I into practice, and investigate ments that can be delivered in conjunction with traditional policy change to improve access and coverage for behavioral cancer treatments are necessary. The research examining sleep medicine services in cancer care. Considering that CBT-I in patients with cancer suggests that it is a generally insomnia in cancer patients is often chronic once it develops, acceptable treatment that is both efc fi acious and durable, both it is important to investigate the most appropriate screening, during and after cancer treatment. Future research in this area assessment, and intervention schedule to efficiently prevent should focus on expanding the populations of patients studied and treat insomnia in this group. and translating evidence into clinical practice. It remains a Second, although CBT-I has demonstrated eff icacy health care priority to expand available treatment options and in the cancer context, there is a significant proportion of increase awareness and access to CBT-I in cancer care. patients who do not consistently adhere to the treatment recommendations. Given that greater adherence to pre- Disclosure scribed treatment regimens (eg, prescribed wake times) The authors declare no conflicts of interest in this work. is associated with greater improvements in sleep, future research should investigate the potential of motivational References enhancement techniques to improve compliance and hence 1. Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006;3(11):e442. response and remittance rates. Patient preference is another 2. American Cancer Society. Global Cancer Facts and Figures. particularly important contributor to patient adherence 2nd ed. Atlanta, GA: American Cancer Society; 2011. Available and outcomes for behavioral interventions like CBT-I, from: http://www.cancer.org/Research/CancerFactsFigures/ GlobalCancerFactsFigures/global-cancer-facts-fig ures-2nd-edition. which require a significant investment of time and active pdf. Accessed April 2, 2014. participation. 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