TITLE: Cognitive Behavioural Therapy for Insomnia in Adults: A Review of the Clinical Effectiveness

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1 TITLE: Cognitive Behavioural Therapy for Insomnia in Adults: A Review of the Clinical Effectiveness DATE: 11 May 2010 CONTEXT AND POLICY ISSUES: Insomnia refers to difficulty initiating and/or maintaining sleep occurring at least three nights per week. 1 This sleep disorder can be broadly subdivided into two types: primary insomnia, where the sleep disorder is independent and there are no other comorbid symptoms and secondary or comorbid insomnia, where insomnia is mitigated by other sleep, psychiatric, or medical conditions. 1 The DSM-IV elaborates by adding that primary insomnia is a complaint of initiating and/or maintaining sleep or non-restorative sleep lasting for at least one month associated with decreased functioning during the day. 2 Insomnia is the most prevalent sleep disorder in the general population, with its prevalence in the adult population around 10-15% increasing to 20% in older adults. 1 Chronic insomnia has been associated with reduced daytime alertness and productivity, poorer quality of life, and other psychiatric and mood disorders. 3 Traditionally pharmacotherapy with benzodiazepines or antidepressants has been the most common treatment offered to patients with insomnia. 3 Its ease of administration and proven efficacy make pharmacotherapy a suitable first-line therapy. 4 However, pharmacotherapy is also associated with side effects, concerns about sedation, and potential adverse interactions with other medications. 4 Sleep medications have shown short-term efficacy, but long-term efficacy is lacking and is associated with risks of adverse effects, tolerance, and dependence. 5,6 Several non-pharmacological interventions have been shown to be effective for clinical management of insomnia, including cognitive behavioural therapy (CBT). 7 CBT is typically aimed at modifying maladaptive sleeping habits, reducing autonomic and cognitive arousal, altering dysfunctional beliefs and attitudes about sleep, and educating patients about healthier practices. 7 The elements associated with CBT include stimulus-control, sleep restriction, sleep hygiene, relaxation, cognitive restructuring, paradoxical intention, and imagery training. 8 Some preliminary results have shown CBT to be as effective as pharmacotherapy in treating patients with primary insomnia. 3 Furthermore, there is increasing evidence that CBT produces longlasting sleep improvements, with minimal adverse effects; and is preferred by patients illustrated by increased compliance in comparison to pharmacotherapies. 5,8 Disclaimer: The Health Technology Inquiry Service (HTIS) is an information service for those involved in planning and providing health care in Canada. HTIS responses are based on a limited literature search and are not comprehensive, systematic reviews. The intent is to provide a list of sources and a summary of the best evidence on the topic that CADTH could identify using all reasonable efforts within the time allowed. HTIS responses should be considered along with other types of information and health care considerations. The information included in this response is not intended to replace professional medical advice, nor should it be construed as a recommendation for or against the use of a particular health technology. Readers are also cautioned that a lack of good quality evidence does not necessarily mean a lack of effectiveness particularly in the case of new and emerging health technologies, for which little information can be found, but which may in future prove to be effective. While CADTH has taken care in the preparation of the report to ensure that its contents are accurate, complete and up to date, CADTH does not make any guarantee to that effect. CADTH is not liable for any loss or damages resulting from use of the information in the report. Copyright: This report contains CADTH copyright material. It may be copied and used for non-commercial purposes, provided that attribution is given to CADTH. Links: This report may contain links to other information available on the websites of third parties on the Internet. CADTH does not have control over the content of such sites. Use of third party sites is governed by the owners own terms and conditions.

2 The high prevalence and burden of insomnia, and the uncertainty of which therapy is optimal validates the need for assessment of the efficacy of CBT as a treatment option, and a survey of the evidence base currently available. This report will review the clinical effectiveness of CBT for adults with primary insomnia. RESEARCH QUESTION: What is the clinical effectiveness of cognitive behavioural therapy for adults with insomnia? METHODS: A limited literature search was conducted on key health technology assessment resources, including PubMed, OVID PsycINFO, The Cochrane Library (Issue 4, 2010), University of York Centre for Reviews and Dissemination (CRD) databases, ECRI (Health Devices Gold), EuroScan, international health technology agencies, and a focused Internet search. The search was limited to English language articles published between January 1, 2005 and April 16, Filters were applied to limit the retrieval to health technology assessments, systematic reviews, meta-analyses, and randomized controlled trials. SUMMARY OF FINDINGS: The search identified one systematic review, 9 one meta-analysis, 10 and six RCTs. 3-7,11 Systematic reviews and meta-analyses Wang et al. conducted a systematic review (2005) evaluating the efficacy of CBT for primary insomnia. 9 This review considered any English language RCT that examined CBT as a therapy in comparison to sleep hygiene, self-monitoring control, waiting-list control, and stimulus control specifically for primary insomnia, while excluding those for other sleep disorders (e.g. circadian rhythm sleep disorder, periodic limb movements). Patients were between the ages of 18 and 65 years and suffered from primary insomnia. Seven studies with a publication date range of , met the inclusion criteria and scored a two or greater on the Jadad scale (indicates that acceptable descriptions of randomization, blinding, and withdrawal were provided). In the included studies the major CBT outcomes examined were sleep onset latency, wake time after sleep onset, sleep efficiency, total sleep time, total wake time, and general sleep quality. After review, the components of CBT that were assessed in these studies were variable making across study comparisons difficult. The systematic review showed that CBT alone was able to produce statistically significant improvements in sleep parameters in patients with primary insomnia. CBT was also superior to placebo, and other non-pharmacological treatments such as stimulus control, relaxation training, or educational programs for most outcomes presented including sleep onset latency, wake after sleep onset, and sleep efficacy. The authors concluded that a multifaceted approach for CBT may be more effective than one that focuses on a single component. 9 A meta-analysis by Irwin et al. (2006) evaluated the relative efficacy of different behavioural treatments for insomnia in two age subgroups; 55 years of age or older versus those under the age of 55 years. 10 The meta-analysis included RCTs that had at least one of five sleep outcomes, including sleep quality, sleep latency, total sleep time, sleep efficiency, and Cognitive Behavioural Therapy for Insomnia in Adults 2

3 awakenings after sleep onset. Patients also had to have primary insomnia, were not permitted to be in a study already included in the meta-analysis, and at least one intervention was a CBT intervention or some recognized variant including progression relaxation, sleep restriction, stimulus control, imagery training, and biofeedback. Twenty-three RCTs were included in the meta-analysis. The results showed that CBT produced a significant benefit (p<0.001) across all sleep outcomes with the exception of total sleep time. In regards to age, the analysis showed that both middle-aged adults and those older than 55 years of age showed similar degrees of improvement in sleep quality, sleep latency, and wakening after sleep onset. The authors identified the lack of evidence for use of CBT for primary insomnia in older adults as a research gap. Randomized controlled trials Edinger et al. (2009) evaluated the efficacy of CBT in comparison to sleep hygiene education control therapy in patients with either primary or comorbid insomnia. 3 Patients were included in the study if they met research diagnostic criteria for insomnia and had a mean total wake time (sleep onset + wake after onset) of more than 60 min per night, while excluding those who were terminally ill or mentally unstable. Of the 81 adult patients included in the study, 40 were associated with primary insomnia. Of these 40 patients, 20 were randomized to receive CBT and the other 20 were randomized to sleep hygiene. Both CBT and sleep hygiene only treatments included four biweekly sessions with a post-treatment assessment and a follow-up at six months. CBT intervention included sleep education, stimulus control, and time-in-bed restrictions. The sleep hygiene intervention covered education about aspects of lifestyle and the bedroom environment that could potentially affect sleep. The results showed that CBT produced significantly greater improvements in measures of sleep onset latency (P=0.005), and sleep efficiency (P=0.05) along with significant reductions in wake time after sleep onset (P=0.02) in comparison to the sleep education intervention in treating primary insomnia. Also, CBT produced similar results for both types of insomnia (N=81) in this cohort. The authors concluded that CBT appears to be a viable psychological insomnia therapy both for those with primary insomnia and nonpsychotic psychiatric conditions. 3 One limitation of this study is the limited sample size, restricting generalizibility of the results. Dose-response effects of CBT were examined by Edinger et al. (2007) in order to determine the optimal number of therapist-guided CBT sessions required to effectively treat primary insomnia. 6 The study design consisted of either one, two, four, or eight CBT sessions carried out over eight weeks, with follow-up at six months. The treatment dose was defined as the number of CBT sessions delivered during the intervention period. The study included 86 patients between the ages of years suffering from primary sleep-maintenance insomnia who were randomized to the four treatment groups. Patients were excluded if they had a comorbid psychiatric disorder or a primary sleep disorder other than insomnia. Primary outcome measures included total sleep time, total wake time, sleep onset latency, sleep efficiency, and wake time after sleep. The results show that the dose of four CBT sessions was the optimal intervention frequency, followed by one session. The four session intervention provided statistical significant improvement of both subjective and clinical outcome measures. The results from the six month follow-up demonstrated that the four session group showed statistically significant (P<0.01) long-term improvements in objective wake time and sleep efficiency measures. Interestingly, the results show a non-linear relationship between dosing of CBT sessions and improvement of Cognitive Behavioural Therapy for Insomnia in Adults 3

4 sleep outcome measures. The authors conclude that 4 individual, biweekly sessions represent the optimal dosing for the CBT intervention tested. 6 Wu et al. (2006) examined the clinical effects of both CBT and pharmacological therapies on sleep measures, sleep-related psychological activity, and daytime function in patients with primary insomnia. 4 The study included 71 patients that were suffering from primary insomnia and had sleep disturbances that caused evident distress or influenced daytime functioning. Patients were excluded if they had a comorbid psychiatric disorder or a primary sleep disorder other than insomnia. Primary sleep outcome measures included total sleep time, sleep onset latency, and sleep efficiency ratio. Patients also completed a psychological and daytime functioning assessment before initiation and after completion of treatment. Of the total cohort, 19 patients were randomized to CBT, 17 were in the pharmacotherapy group (temazepam), 18 in the combination group (CBT+pharmacotherapy), and 17 were randomized to the placebo group. The treatment duration for all arms was eight weeks with follow-up conducted at three and eight months. The results show that both CBT and pharmacotherapy were statistically more effective after treatment in reducing sleep onset latency (P<0.001) and improving sleep efficiency (P<0.05) and total sleep time (P<0.004) than placebo. At the end of treatment, the patients on pharmacotherapy showed significant differences in comparison to CBT for all both subjective and objective sleep outcome measures. However, at the three month and eight month follow-up, CBT patients showed relative superiority to the other treatments in terms of the same sleep outcome measures. CBT was also shown to be superior to the other treatments for sleep-related psychological activity and daytime function. In summary, the results showed that CBT was the most effective long-term intervention for sleep measures, sleep-related psychological activity, and daytime function in patients with primary insomnia. An additional RCT from Sivertsen et al. (2006) looked at the comparative efficacy of CBT versus pharmacotherapy with zopiclone in older patients with primary insomnia. 11 The study included 46 adults who were 55 years or older, with primary insomnia, and complaints of impaired daytime functioning. Patients were excluded if they had a comorbid psychiatric disorder, were using antidepressive or antipsychotic medication, or suffered from a primary sleep disorder other than insomnia. The primary sleep outcome measures included total wake time, total sleep time, sleep efficiency, and duration of slow-wave sleep. The 18 CBT treated subjects attended six weekly sessions and were followed up at six months. The results showed that CBT improved short- and long-term sleep outcome measures in comparison with zopiclone (n=16) and placebo (n=12). Participants in the CBT group spent statistically significant more time in slow-wave sleep in comparison to both placebo (P=0.03) and zopiclone (P=0.002) groups, and spent significantly less time awake during the night after treatment (P=0.001). The authors concluded that interventions based on CBT are superior to zopiclone treatment both in short- and long-term management of insomnia in older adults. 11 A pair of RCTs examined the impact of self-help interventions with behavioural components. The first is a study by Jansson and Linton (2005), which investigated the comparative efficacy in treating primary insomnia with CBT in a group setting versus a self-help information package. 7 The study included 165 adults with primary insomnia, with a duration of insomnia of three to 12 months. After a one year follow-up, 136 patients had completed the entire study ([CBT], n=64; [control], n=72). The primary sleep outcome measures included sleep onset latency, time awake after sleep onset, total sleep time, sleep quality, and sleep efficiency. Other outcome measures included dysfunctional beliefs and attitudes about sleep, and negative daytime symptoms. The Cognitive Behavioural Therapy for Insomnia in Adults 4

5 results indicated that CBT is statistically more effective on all sleep measures in comparison to self-help patients. These differences were shown to be clinically meaningful in the CBT group at the one year follow-up. The authors concluded that CBT group intervention was effective in producing reductions in dysfunctional beliefs and attitudes about sleep, negative daytime symptoms, as well as durable improvements in sleep patterns when compared to self-help information for patients with primary insomnia. A study by Morin et al. (2005) also evaluated the efficacy of a self-help behavioural intervention as a possible therapy for primary insomnia. 5 The longitudinal study included 192 patients who suffered from primary insomnia and were randomly assigned to receive either the self-help behavioural intervention or no treatment control. The self-help intervention was administered to 96 subjects and was comprised of six psychoeducational booklets covering varying aspects of insomnia therapy including healthy sleep practices, behavioural sleep scheduling, and cognitive strategies. The results indicated that the self-help behavioural intervention was effective in lessening primary insomnia in comparison to no treatment. There was a statistically significant improvement in all the main sleep parameters, including subjective sleep quality, and many of these changes persisted at the six-month follow up. Even though these improvements were statistically significant, the clinical magnitude was fairly modest. Nevertheless, these improvements are modest in comparison but are consistent with those found in previous selfhelp interventions studies. 12,13 Limitations Few studies have been conducted to evaluate the clinical efficacy of CBT for primary insomnia. The studies identified enrolled low numbers of patients (n = for each arm), and several were excluded based on study design (naturalistic, case studies, observational). Also, a portion of the evidence available evaluated the effectiveness of CBT in patients with secondary or comorbid insomnia, with fewer considering primary insomnia. Furthermore, there does not seem to be any formalized agreement on which elements of behavioural therapy should be included in the intervention known collectively as CBT. As a result, there is difficulty in pooling and comparing data across studies to assess comparative efficacy for treatment of primary insomnia. Self-help behavioural tools are an example of an intervention that may be associated with CBT but may also be distinctive enough to be considered an independent tool. The epidemiological evidence has shown that chronic insomnia is more prominent in the elderly population; however there is a relative paucity of research that has been conducted on CBT as an intervention for this population. 10 CONCLUSIONS AND IMPLICATIONS FOR DECISION OR POLICY MAKING: In the available literature, CBT seems to be effective in mediating the symptoms of primary insomnia as indicated by sleep outcome measures. The results demonstrate that CBT is as effective and in some studies even more effective in treating primary insomnia than available pharmacotherapies. Based on the available evidence, CBT also seems to have longer lasting effects in comparison to other therapies, as observed at patient follow-ups, with fewer adverse events. The literature supports the notion that pharmacotherapy remains to be first-line therapy for primary insomnia, while CBT is still relatively unknown and underused by health-care practitioners. Some barriers that need to be addressed may include the need for increased exposure of this intervention, the extra time and effort required to implement CBT, and limited Cognitive Behavioural Therapy for Insomnia in Adults 5

6 availability. Additional training for physicians may be necessary to make this therapy more accessible for patients. Comparative economic assessment of this intervention may also be of interest as it may be more costly in the short-term, but may show cost saving benefits long-term. These issues may be a consideration for decision-making about the use of CBT for treatment of patients with primary insomnia. PREPARED BY: Health Technology Inquiry Service htis@cadth.ca Tel: Cognitive Behavioural Therapy for Insomnia in Adults 6

7 REFERENCES: 1. Malaffo M, Espie CA. Cognitive and behavioural treatments of primary insomnia: a review. Minerva Psichiatrica. 2007;48(3): Diagnostic and statistical manual of mental disorders. 4th text rev. ed. Washington: American Psychiatric Association; p. 3. Edinger JD, Olsen MK, Stechuchak KM, Means MK, Lineberger MD, Kirby A, et al. Cognitive behavioral therapy for patients with primary insomnia or insomnia associated predominantly with mixed psychiatric disorders: a randomized clinical trial. Sleep Apr 1;32(4): Wu R, Bao J, Zhang C, Deng J, Long C. Comparison of sleep condition and sleep-related psychological activity after cognitive-behavior and pharmacological therapy for chronic insomnia. Psychother Psychosom. 2006;75(4): Morin CM, Beaulieu-Bonneau S, LeBlanc M, Savard J. Self-help treatment for insomnia: a randomized controlled trial. Sleep Oct 1;28(10): Edinger JD, Wohlgemuth WK, Radtke RA, Coffman CJ, Carney CE. Dose-response effects of cognitive-behavioral insomnia therapy: a randomized clinical trial. Sleep Feb 1;30(2): Jansson M, Linton SJ. Cognitive-behavioral group therapy as an early intervention for insomnia: a randomized controlled trial. J Occup Rehabil Jun;15(2): van Straten A., Cuijpers P. Self-help therapy for insomnia: a meta-analysis. Sleep Med Rev Feb;13(1): Wang MY, Wang SY, Tsai PS. Cognitive behavioural therapy for primary insomnia: a systematic review. J Adv Nurs Jun;50(5): Irwin MR, Cole JC, Nicassio PM. Comparative meta-analysis of behavioral interventions for insomnia and their efficacy in middle-aged adults and in older adults 55+ years of age. Health Psychol Jan;25(1): Sivertsen B, Omvik S, Pallesen S, Bjorvatn B, Havik OE, Kvale G, et al. Cognitive behavioral therapy vs zopiclone for treatment of chronic primary insomnia in older adults: a randomized controlled trial. JAMA Jun 28;295(24): Strom L, Pettersson R, Andersson G. Internet-based treatment for insomnia: a controlled evaluation. J Consult Clin Psychol Feb;72(1): Mimeault V, Morin CM. Self-help treatment for insomnia: bibliotherapy with and without professional guidance. J Consult Clin Psychol Aug;67(4): Cognitive Behavioural Therapy for Insomnia in Adults 7