Originally published as JCO Early Release 10.1200/JCO.2007.13.9006 on June 30 2008

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Randomized Controlled Clinical Effectiveness Trial of Cognitive Behavior Therapy Compared With Treatment As Usual for Persistent Insomnia in Patients With Cancer

Colin A. Espie, Leanne Fleming, James Cassidy, Leslie Samuel, Lynne M. Taylor, Craig A. White, Neil J. Douglas, Heather M. Engleman, Heidi-Louise Kelly, James Paul

From the University of Glasgow Sleep Centre, Southern General Hospital; Beatson Oncology Centre, Western Infirmary, Glasgow; Anchor Unit, Aberdeen Royal Infirmary, Aberdeen; School of Health, University Campus Ayr, Beech Grove, Ayr; Edinburgh Sleep Centre, Edinburgh Royal Infirmary, Edinburgh, United Kingdom

Corresponding author: Colin A. Espie, PhD, FBPsS, University of Glasgow Sleep Centre, Southern General Hospital, Glasgow, G51 4TF United Kingdom; e-mail: C.Espie{at}clinmed.gla.ac.uk

	ABSTRACT

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Purpose Persistent insomnia is a common complaint in cancer survivors, but is seldom satisfactorily addressed. The adaptation to cancer care of a validated, cost-effective intervention may offer a practicable solution. The aim of this study was to investigate the clinical effectiveness of protocol-driven cognitive behavior therapy (CBT) for insomnia, delivered by oncology nurses.

Patients and Methods Randomized, controlled, pragmatic, two-center trial of CBT versus treatment as usual (TAU) in 150 patients (103 females; mean age, 61 years.) who had completed active therapy for breast, prostate, colorectal, or gynecological cancer. The study conformed to CONSORT guidelines. Primary outcomes were sleep diary measures at baseline, post-treatment, and 6-month follow-up. Actigraphic sleep, health-related quality of life (QOL), psychopathology, and fatigue were secondary measures. CBT comprised five, small group sessions across consecutive weeks, after a manualized protocol. TAU represented normal clinical practice; the appropriate control for a clinical effectiveness study.

Results CBT was associated with mean reductions in wakefulness of 55 minutes per night compared with no change in TAU. These outcomes were sustained 6 months after treatment. Standardized relative effect sizes were large for complaints of difficulty initiating sleep, waking from sleep during the night, and for sleep efficiency (percentage of time in bed spent asleep). CBT was associated with moderate to large effect sizes for five of seven QOL outcomes, including significant reduction in daytime fatigue. There was no significant interaction effect between any of these outcomes and baseline demographic, clinical, or sleep characteristics.

Conclusion CBT for insomnia may be both clinically effective and feasible to deliver in real world practice.

	INTRODUCTION

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Sleep disturbance is an important, common, and distressing problem for cancer patients,^1-3 19% to 30% of whom meet insomnia diagnostic criteria,^4,5 including negative daytime consequences.^6,7 However, insomnia is often unrecognized or poorly managed^8,21 and long-term pharmacotherapy is not desirable,^9-12 especially when fatigue is problematic,¹³ yet 25% of cancer patients regularly take sleeping pills.⁵

Cognitive behavior therapy (CBT), effective for primary insomnia,^14-19 is promising because insomnia often arises during stress^5,6,20 and is perpetuated by behavioral and mental factors.^6,15,20,21

Two randomized trials of CBT for insomnia in patients with cancer have been reported. Cannici et al²² allocated 30 participants with a range of cancers to a three-session relaxation program or no treatment. Self-reported sleep latency reduced in the relaxation group. Recently, Savard et al²³ studied 57 women (mean age, 54 years) with insomnia caused/aggravated by breast cancer. CBT comprised 8 weekly group sessions (each 90 minutes) led by a psychologist. Sustained reductions in sleep latency and wakefulness were observed after CBT relative to control. There was no increase in total sleep but increases in sleep efficiency (proportion of time in bed spent asleep) averaged 15%.

This article reports a pragmatic, intention-to-treat evaluation of nurse-administered CBT, to evaluate potential for real world implementation of CBT across a range of cancer subtypes, and within the clinical effectiveness tradition. Treatment as usual (TAU) was employed as the control arm.

	PATIENTS AND METHODS

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Aims and Objectives
Our overall aim was to test the clinical effectiveness of CBT for persistent insomnia associated with cancer in the real world. Major research questions were: "Is CBT superior to TAU in reducing chronic sleep disturbance and improving quality of life functioning?" "Are observed improvements durable?" and "Are there predictors of good outcome or contraindications to CBT as a first line treatment for insomnia in routine care?"

Participants
Potential participants (+18 years) were attending follow-up clinics at the Beatson Oncology Centre, Glasgow or Anchor Unit, Aberdeen Royal Infirmary from December 2003 to June 2005. They had to have a diagnosis of breast, prostate, bowel, or gynecological cancer, and to satisfy diagnostic criteria for chronic insomnia; mean value longer than 30 minutes for complaint of delayed sleep-onset latency (SOL) and/or wake time after sleep onset (WASO), occurring 3 nights per week for 3 months and affecting daytime function.^5,24 Participants also had to screen more than 5 on the Pittsburgh Sleep Quality Index (PSQI),^25,26 a psychometrically robust instrument that identifies clinically significant sleep disturbance. Thus acute insomnia and transient effects associated with cancer treatment/adverse effects were excluded. Treatment (radiation therapy or chemotherapy) had to be completed by 1 month with no further anticancer therapy planned (excepting adjuvant hormone therapy). Participants with acute illness, estimated prognosis fewer than 6 months, confusional problems or drug misuse, or with evidence of other sleep disorders (eg, sleep apnea; screened by reports of nightly snoring and nocturnal breathing pauses, plus Epworth sleepiness scale²⁷ more than 10) or of untreated psychiatric disorder, were excluded. Potential participants were notified of the study by posters/leaflets in clinic waiting areas, by mailing information to those attending upcoming clinics, or directly by staff on attendance. All participants gave written informed consent and their medical consultant agreed to their participation. The protocol was approved by local NHS research ethics committees.

Sample Characteristics
Of 220 patients who consented, 31 failed to respond to further contact (25 females; mean age, 56 years [±10.2 years]) and 39 were excluded (23 females; 61 years [±13.4 years]; Fig 1). The remaining 150 participants were randomly assigned (103 females; 61 years [±10.5 years]; age range, 38 to 86 years; Table 1).

View larger version (44K): [in this window] [in a new window] [PowerPoint Slide for Teaching]   Fig 1. Participant flow chart. CBT, cognitive behavior therapy; TAU, treatment as usual.

Table 1 summarizes other information on psychopathology (Hospital Anxiety and Depression Scale [HADS]), fatigue (Fatigue Symptom Inventory [FSI]), and cancer-related quality of life (QOL; Functional Assessment of Cancer Therapy Scale–general [FACT-G]). The HADS has been validated for use for patients with cancer to screen for anxiety and depressive symptoms.^28,29 Median values for both subscales was 8, however, 20% (CBT) and 23.3% (TAU) of participants screened 11 for HADS anxiety suggesting a sizeable minority had anxiety problems.³⁰ Applying this criterion to the HADS depression subscale revealed a smaller proportion (CBT, 9.4%; TAU, 7%) with depressive symptoms. Twenty participants (13%) were receiving concurrent treatment for depression.

The FACT-G³¹ and the FSI³² also have good validity and internal consistency.^33,34 Fatigue was marginally higher than that reported in other centers. For example, the FSI interference score (extent to which fatigue interferes with QOL) in our total sample was higher (median, 3.57; interquartile range, 1.86 to 5.14) than in a recent validation study (mean, 1.6; standard deviation [SD], 1.8).³⁴ Normative comparison on the FACT-G total score revealed that QOL in our sample (median, 80; IR 66 to 90) reflected published data from several large cohorts (mean, 81; SD, 17.0).³⁵

All participants had insomnia longer than 6 months with group median of 30 months, and 25% had insomnia longer than 5 years. Two- thirds reported unrelenting insomnia and 23% took hypnotic medication 1 night of the 10-night baseline. Insomnia was typically severe (median PSQI, 13),²⁵ higher than in a recent cancer validation study (mean, 8.15; SD, 4.70).²⁶ Participants were not excessively sleepy during the daytime. Symptomatic sleep complaint comprised both difficulty falling asleep (group median SOL, 35.25 minutes) and difficulty maintaining sleep (WASO, 58.5 minutes.). This reflects clinical insomnia in our patients because total wakefulness was around 90 minutes, and total sleep time (TST) around 6.5 hours. Median SE was 80.6%, below the 85% lower limit of normal sleep.

Experimental Design
The study conformed to a pragmatic, two-center, randomized trial comparing CBT with TAU. Major assessments were at baseline, post-treatment, and follow-up 6 months later. Suitable participants were allocated to either CBT or TAU by means of the centralized computer-based registration/randomization service available within the Cancer Research UK Clinical Trials Unit, Glasgow. We stratified for center, prerandomization PSQI scores, existing treatment for insomnia, and tumor type using the minimization method. A 2:1 treatment allocation, in favor of the intervention, was selected because this made efficient use of available CBT sessions and minimized the time a patient had to wait before starting CBT, thereby, reducing patient dropout. Due to the nature of the intervention, it was not possible to blind participants or therapists to allocation. No adverse events were reported with either CBT or TAU.

Measures
Potential participants were screened by telephone, when preliminary diagnostic information and medical/psychiatric history was collected. A comprehensive structured interview obtained a detailed history, supplemented by completion of the PSQI, Epworth sleepiness scale, HADS, FSI, and FACT-G.

Subjective sleep was assessed using a sleep diary,¹² completed for 10 days at each of three assessment points; baseline, post-treatment, and follow-up. Such diaries are the staple tool of insomnia assessment and offer a valid, relative index of sleep disturbance when used as repeated measures.¹⁸ Items "how long did it take you to fall asleep last night" and "how long were you awake in total last night, after you first fell asleep?" assessed the central insomnia dimensions of difficulty initiating (SOL) and maintaining (WASO) sleep. The diary also enquired about bedtime and rising time, from which total time in bed, and thence SE were calculated: (SOL + WASO/time in bed) x 100. Participants were trained to complete diaries against established criteria.³⁶

Actigraphy provided an objective estimate of sleep pattern over the same 10-day period. Actigraphs are nonintrusive devices that record movement through an accelerometer-microprocessor link.³⁷ Actigraphs (Cambridge Neurotechnology, AW-4, Cambridge, United Kingdom) were worn 24-hours per day on the nondominant wrist. An algorithm (maximum sampling frequency 32 Hz, recording all movement over 0.05g., filters set 3 to 11 Hz) enabled Sleepwatch (Cambridge Neurotechnology, Cambridge, United Kingdom) software to estimate the sleep parameters SOL/WASO/SE using 1-minute epochs.^43,44

Data from the FSI and FACT-G taken at each assessment provided secondary outcome information to evaluate the effectiveness of CBT relative to TAU.

Interventions
CBT. Participants assigned to CBT attended five, weekly, 50-minute sessions during the early afternoon or early evening. These were conducted in groups of four to six at Maggie's Center (Glasgow) and the Clan Center (Aberdeen). These centers, run by the voluntary sector, offer an informal environment, close to but not part of the hospital itself. The content, aims, and objectives of each session are summarized in online-only Table A1 (further descriptions in Morin and Espie,³⁸ or from C.A.E.). The intervention included standard CBT components such as stimulus control, sleep restriction, and cognitive therapy strategies.

Therapists. We trained four experienced cancer nurses, who were released on a part-time basis from oncology nursing duties, to deliver CBT. (These were G-grade nurses in the United Kingdom National Health Service, equivalent to ward sister level of experience.) On average each nurse worked 6 hours per week on the study. We followed a model of training-to-criterion standards. That is, these nurses had to demonstrate competence in the practical delivery of the CBT program. This was ensured by participation in a short CBT course, apprenticeship learning opportunities, ongoing mentoring by an experienced clinical psychologist, and evaluation of audiotapes from randomly selected sessions.

TAU and integrity-fidelity of treatment allocation. Effectiveness studies should replicate real clinical practices and reflect validity and generalizability.³⁹ Because we were recruiting cancer patients with chronic insomnia, we expected concurrent physical and psychological symptoms, as well as concurrent treatments (except they had completed active anticancer treatment). The TAU comparison group thus represented normal clinical practice, where physicians were free to offer appointments, to prescribe, and to maintain/discontinue prescriptions. Effectively, TAU participants received no additional help for their insomnia. CBT was, in reality, a CBT plus TAU condition because the protocol explicitly permitted normal continuation of health care. At the end of the protocol, the TAU group was provided with The Good Sleep Guide.⁴⁰

The integrity of the treatment allocations was ensured using several procedures (Table A2, online only).

Statistical Analyses
The study was designed to have 80% power to detect a standardized difference of 0.5 between the treatments (consistent with published meta-analytic data)^18-20 in the four primary sleep outcome measures (SOL, WASO, TST, SE) at post-treatment. A significance level of 0.0125 was chosen to adjust for multiple comparisons. These criteria implied recruiting 204 participants. In practice, slow recruitment meant that a total of 150 patients was randomly assigned, giving 80% power to detect a slightly larger standardized difference of 0.59.

The study was analyzed on an intention-to-treat basis. Comparison between treatments in terms of sleep and QOL variables was derived from fitting a linear mixed model using a first-order autoregressive variance structure, incorporating baseline value and other variables used for minimization as covariates. Data were transformed to approximate normality guided by the constructed variable approach before applying the model.⁴⁵ Interactions between SE and baseline parameters were examined in the context of this model; for this purpose continuous baseline data were dichotomized at the median.

P values for QOL end points were adjusted for multiple comparisons within each assessment time point using the Hochberg procedure.⁴⁶ In Figures 2 and 3 showing median change (95% CIs) in sleep and QOL parameters from baseline, confidence limits were derived from bootstrap sampling. Association between changes in QOL and changes in SE from baseline were examined using Spearman's rank correlation coefficient. Association between actigraphic and diary measures was also assessed using Spearman's correlation. Finally, the proportion of patients achieving SE higher than 85% was compared between study arms using logistic regression incorporating the baseline value and the other variables used for minimization.

View larger version (11K): [in this window] [in a new window] [PowerPoint Slide for Teaching]   Fig 2. Changes in sleep diary measures from baseline by treatment arm. Points represent median change and the bars the range of a 95% CI for the median.

View larger version (18K): [in this window] [in a new window] [PowerPoint Slide for Teaching]   Fig 3. Changes in quality of life (QOL) measures from baseline by treatment arm. Points represent median change and the bars the range of a 95% CI for the median. QOL measures have been standardized onto a 0 to 100 scale.

	RESULTS

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Sleep Pattern
Figure 2 presents a visual comparison, by treatment arm, of median change scores (baseline to post-treatment, baseline to follow-up) for each self-reported sleep variable. Table 2 provides estimates of standardized effects (CBT and TAU) relating to these variables.

This pattern of results generally held at 6 months post-treatment. Effect sizes were somewhat reduced for WASO, SOL, and SE but remained moderate and statistically significant (P < .001). Changes in TST again were not statistically significant.

In summary, CBT was associated with median reduction in insomnia symptoms of almost 1 hour (SOL + WASO) compared with no change following TAU. Post-treatment and follow-up SE of 85% is commonly regarded as the lower limit of normal sleep. A higher proportion of CBT participants achieved this criterion, 51% (51 of 100) versus 34% on TAU (17 of 50; P = .008); at 6 months this difference was no longer significant (44%; 44/100 of patients on CBT; 48%; 24 of 50 on TAU; P = .966).

Tables 3 and 4 presents actigraphic results for the same sleep variables. Moderate effect sizes in favor of CBT were observed for SOL and WASO post-treatment (significant at P < .05). A large effect was observed on TST reflecting a reduction in sleep in the CBT arm. This reflects the impact of the sleep restriction component. At 6 months, no significant actigraphic effects were observed. It should also be noted that the SOL and WASO changes were not significant when adjusted to the conservative 1.25% level of statistical significance. Associations between actigraphic and corresponding sleep diary measures of SOL, WASO, TST and SE were modest (0.37, 0.25, 0.47 and 0.31, respectively at baseline). However, these are typical of relationships observed in other contemporary studies.⁴³

Dependence of Treatment Effect on Baseline Characteristics
No statistically significant interactions were found between the CBT effect and sex (P = .640), age (P = .402), civil status (P = .464), occupational status (P = .884), Functional Assessment of Cancer Therapy (FACT)-Physical (P = .471), FACT-Functional (P = .186), or FSI interference (P = .892). Similarly, baseline sleep quality (P = .883), insomnia duration (P = .645), and psychological states (anxiety, P = .471; depression, P = .887) did not mediate response. There was a significant interaction with tumor type (P = .027) and treatment location (P = .012); in a model containing both these terms only treatment location retained statistical significance. Average standardized effect was higher in Glasgow (1.28; less than .0011) compared with Aberdeen (0.64; P = .002), although both were statistically significant and indicate benefit from CBT.

Qualitative Reports From Patients
We did not formally evaluate what patients thought of CBT. However, around 50 attended an open evening several months after completion of the trial. Table A3, online only, presents a sample of their evaluative comments.

	DISCUSSION

TOP ABSTRACT INTRODUCTION PATIENTS AND METHODS RESULTS DISCUSSION AUTHORS' DISCLOSURES OF... AUTHOR CONTRIBUTIONS Appendix REFERENCES

 
Patients with cancer report that their sleep can be disturbed during stressful times associated with diagnosis/treatment, and persistently after discharge after anticancer therapy. Findings from this pragmatic trial suggest that a cognitive-behavioral approach may be clinically effective. Our results demonstrate sustained improvements in sleep with large effect sizes for subjectively estimated time taken to fall asleep and nocturnal wake time, comparable to the primary insomnia literature.^17-20 More modest effects at post-treatment were observed actigraphically. Importantly, CBT response was not attributable to any demographic or clinical subset. Moreover, we found generalized improvements in QOL, fatigue, and daytime well being.

Although psychologically based, CBT was delivered by oncology nurses, with no prior experience nor expertise in sleep medicine. This testifies to the potential of CBT itself, and to the feasibility of this treatment model. Scarce specialists might train/supervise available staff to deliver CBT as a first level intervention. Herein we used cancer nurses but we believe the important thing is that the program is delivered according to protocol, by a credible professional. We did not model cost effectiveness but extending the skills of available personnel could be economical, and permit patients with complex sleep problems to filter through for expert care. We also observed that this solution-focused approach was highly acceptable to patients and professionals. Indeed, insomnia may offer a nonstigmatizing entry point to psychological care.

Further studies are required, both in the efficacy and the effectiveness tradition. The former, explanatory approach emphasizes rigorous entry criteria and highly controlled quasiexperimental design. The latter, of which this study is a prototype, resembles real world practice, and informs care delivery. These designs are complementary and taken together will provide evidence to inform best practice for this neglected problem.

	AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

TOP ABSTRACT INTRODUCTION PATIENTS AND METHODS RESULTS DISCUSSION AUTHORS' DISCLOSURES OF... AUTHOR CONTRIBUTIONS Appendix REFERENCES

 
The author(s) indicated no potential conflicts of interest.

	AUTHOR CONTRIBUTIONS

TOP ABSTRACT INTRODUCTION PATIENTS AND METHODS RESULTS DISCUSSION AUTHORS' DISCLOSURES OF... AUTHOR CONTRIBUTIONS Appendix REFERENCES

 
Conception and design: Colin A. Espie, Leslie Samuel, Lynne M. Taylor, Craig A. White, Neil J. Douglas, Heather M. Engleman, Heidi-Louise Kelly, James Paul

Administrative support: Colin A. Espie, Leanne Fleming, James Cassidy, Lynne M. Taylor

Provision of study materials or patients: Colin A. Espie, James Cassidy, Leslie Samuel, James Paul

Collection and assembly of data: Colin A. Espie, Leanne Fleming, Lynne M. Taylor, James Paul

Data analysis and interpretation: Colin A. Espie, Leanne Fleming, James Paul

Manuscript writing: Colin A. Espie, Leanne Fleming, James Paul

Final approval of manuscript: Colin A. Espie, Leanne Fleming, James Cassidy, Leslie Samuel, Lynne M. Taylor, Craig A. White, Neil J. Douglas, Heather M. Engleman, Heidi-Louise Kelly, James Paul

	Appendix

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	ACKNOWLEDGMENTS

 
We thank the following institutions for recruitment assistance: Beatson Oncology Centre, Western Infirmary, Gartnavel Hospital, Stobhill Hospital, Aberdeen Royal Infirmary, Dr Greys Hospital, Maggie's Centre, and Clan Centre. We also thank Patricia Munro, Dorothy Molloy, Margaret Durward, Kenny Ferguson, and Alison Thomson for their support.

	NOTES

 
published online ahead of print at www.jco.org on June 30, 2008.

Supported by Cancer Research UK (Grant No. C8265/A3036) and from the Dr Mortimer and Theresa Sackler Foundation.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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Submitted November 13, 2007; accepted February 11, 2008.

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