Colin A. Espie

British Association for Psychopharmacology consensus statement on evidence-based treatment of insomnia, parasomnias and circadian rhythm disorders.

Sleep disorders are common in the general population and even more so in clinical practice, yet are relatively poorly understood by doctors and other health care practitioners. These British Association for Psychopharmacology guidelines are designed to address this problem by providing an accessible up-to-date and evidence-based outline of the major issues, especially those relating to reliable diagnosis and appropriate treatment. A consensus meeting was held in London in May 2009. Those invited to attend included BAP members, representative clinicians with a strong interest in sleep disorders and recognized experts and advocates in the field, including a representative from mainland Europe and the USA. Presenters were asked to provide a review of the literature and identification of the standard of evidence in their area, with an emphasis on meta-analyses, systematic reviews and randomized controlled trials where available, plus updates on current clinical practice. Each presentation was followed by discussion, aimed to reach consensus where the evidence and/or clinical experience was considered adequate or otherwise to flag the area as a direction for future research. A draft of the proceedings was then circulated to all participants for comment. Key subsequent publications were added by the writer and speakers at draft stage. All comments were incorporated as far as possible in the final document, which represents the views of all participants although the authors take final responsibility for the document.

The natural history of insomnia: a population-based 3-year longitudinal study.

BACKGROUND Despite its high prevalence, little information is available about the natural history of insomnia. The extent to which episodes of insomnia will persist or remit over time is difficult to predict. We examined the natural history of insomnia and describe the most common trajectories over 3 years. METHODS Three hundred eighty-eight adults (mean [SD] age, 44.8 [13.9] years; 61% women) were selected from a larger population-based sample on the basis of the presence of insomnia at baseline. They completed standardized sleep/insomnia questionnaires at 3 annual follow-up assessments. For each follow-up assessment, participants were classified into 1 of 3 groups (individuals with an insomnia syndrome, individuals with insomnia symptoms, and individuals with good sleep) on the basis of algorithms using standard diagnostic criteria for insomnia. Rates of persistent insomnia, remission, and relapse were computed for each group. RESULTS Of the study sample, 74% reported insomnia for at least 1 year (2 consecutive assessments) and 46% reported insomnia persisting over the entire 3-year study. The course of insomnia was more likely to be persistent in those with more severe insomnia at baseline (ie, insomnia syndrome) and in women and older adults. Remission rate was 54%; however, 27% of those with remission of insomnia eventually experienced relapse. Individuals with subsyndromal insomnia at baseline were 3 times more likely to remit than worsen to syndrome status, although persistence was the most frequent course in that group as well. CONCLUSION These findings indicate that insomnia is often a persistent condition, in particular when it reaches the diagnostic threshold for an insomnia disorder.

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

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.

The clinical effectiveness of cognitive behaviour therapy for chronic insomnia: implementation and evaluation of a sleep clinic in general medical practice

Chronic insomnia is a very common clinical condition which may respond well to non-pharmacological treatment. Indeed, the literature supports the efficacy of cognitive behaviour therapy (CBT). However, there has been no substantial study of clinical effectiveness. Since insomniacs typically present in general medical practice this is a crucial gap in the outcome research. This study, therefore, specifically investigated the clinical effectiveness of CBT delivered by Health Visitors (primary care nurses) trained as therapists. One hundred and thirty-nine insomniacs (mean age 51 yr) were randomised to CBT or Self-Monitoring Control (SMC) in a controlled trial. CBT comprised six group sessions (n=4 to 6 patients). After the controlled phase, SMC patients entered deferred treatment (CBT-DEF), allowing both treatment replication and long-term outcome to be investigated for a sizeable, treated sample. Repeated measures ANOVAs demonstrated superiority of CBT over SMC in substantially reducing sleep latency and wakefulness during the night. CBT-DEF replicated similar effects and maintained improvement was observed in both groups one year later. Furthermore, total sleep increased significantly during follow-up and 84% of patients initially using hypnotics remained drug-free. Results suggest that CBT administered by Health Visitors offers a clinically effective treatment for insomnia.

A Randomized, Placebo-Controlled Trial of Online Cognitive Behavioral Therapy for Chronic Insomnia Disorder Delivered via an Automated Media-Rich Web Application

STUDY OBJECTIVES The internet provides a pervasive milieu for healthcare delivery. The purpose of this study was to determine the effectiveness of a novel web-based cognitive behavioral therapy (CBT) course delivered by an automated virtual therapist, when compared with a credible placebo; an approach required because web products may be intrinsically engaging, and vulnerable to placebo response. DESIGN Randomized, placebo-controlled trial comprising 3 arms: CBT, imagery relief therapy (IRT: placebo), treatment as usual (TAU). SETTING Online community of participants in the UK. PARTICIPANTS One hundred sixty-four adults (120 F: [mean age 49y (18-78y)] meeting proposed DSM-5 criteria for Insomnia Disorder, randomly assigned to CBT (n = 55; 40 F), IRT placebo (n = 55; 42 F) or TAU (n = 54; 38 F). INTERVENTIONS CBT and IRT each comprised 6 online sessions delivered by an animated personal therapist, with automated web and email support. Participants also had access to a video library/back catalogue of session content and Wikipedia style articles. Online CBT users had access to a moderated social network/community of users. TAU comprised no restrictions on usual care and access to an online sleep diary. MEASUREMENTS AND RESULTS Major assessments at baseline, post-treatment, and at follow-up 8-weeks post-treatment; outcomes appraised by online sleep diaries and clinical status. On the primary endpoint of sleep efficiency (SE; total time asleep expressed as a percentage of the total time spent in bed), online CBT was associated with sustained improvement at post-treatment (+20%) relative to both TAU (+6%; d = 0.95) and IRT (+6%: d = 1.06), and at 8 weeks (+20%) relative to IRT (+7%: d = 1.00) and TAU (+9%: d = 0.69) These findings were mirrored across a range of sleep diary measures. Clinical benefits of CBT were evidenced by modest superiority over placebo on daytime outcomes (d = 0.23-0.37) and by substantial improved sleep-wake functioning on the Sleep Condition Indicator (range of d = 0.77-1.20). Three-quarters of CBT participants (76% [CBT] vs. 29% [IRT] and 18% [TAU]) completed treatment with SE > 80%, more than half (55% [CBT] vs. 17% [IRT] and 8% [TAU]) with SE > 85%, and over one-third (38% [CBT] vs. 6% [IRT] and 0% [TAU]) with SE > 90%; these improvements were largely maintained during follow-up. CONCLUSION CBT delivered using a media-rich web application with automated support and a community forum is effective in improving the sleep and associated daytime functioning of adults with insomnia disorder. CLINICAL TRIAL REGISTRATION ISRCTN - 44615689.

Insomnia and health-related quality of life.

Health-related Quality of Life (HRQoL) has become an important construct in contemporary medicine and health care, permitting assessment of disorder burden and evaluation of interventions on various aspects of functioning, in a standardized manner. Here we review literature on the measurement of HRQoL in insomnia populations, and the extent to which insomnia treatment improves domains of HRQoL. It is concluded from the relatively small literature that insomnia impacts on diverse areas of HRQoL, and that both pharmacological and non-pharmacological interventions can produce, to varying degrees, improvements in domains spanning physical, social and emotional functioning. Limitations of the current literature are identified; with particular emphasis on measurement and conceptual shortcomings. Suggestions are made in relation to improving the quality of future research, and how to further shed light on the impact of insomnia - and treatment thereof - on both HRQoL and global quality of life.

The sleep of remitted bipolar outpatients: a controlled naturalistic study using actigraphy

BACKGROUND Several sleep laboratory studies suggest sleep abnormalities in bipolar disorder. However, this is the first study to compare remitted bipolar subjects with controls on actigraphic and subjective sleep parameters in a naturalistic setting over 5 nights. METHODS Nineteen subjects with Bipolar I Disorder and 19 age- and gender-matched healthy controls were included. Objective sleep parameters were estimated using wrist actigraphs. Subject-rated sleep diaries and mood ratings were also completed. Sleep data were averaged for each subject across nights, and raw score standard deviations were calculated as a measure of within-subject variability. RESULTS Multivariate analyses of variance found significant group differences for both actigraphic (F(4,33)=3.80, P=0.012) and subjective measures (F(4,31)=3.18, P=0.027). Univariate analyses identified reliable differences in sleep onset latency (subjective), sleep duration (subjective), and variability of sleep duration and night wake time (actigraphic). Binary backward stepwise logistic regression demonstrated that a combination of three sleep measures correctly predicted disorder status in 84% of cases. LIMITATIONS Failure to match on sociodemographic and employment status is a limitation that may provide an alternative explanation for some findings. Furthermore, in the bipolar group 18 of 19 subjects were in receipt of psychotropic medication, compared to none of the healthy control group. Also, no information was recorded about family history of mental disorders in the control group. CONCLUSIONS The study suggests that the sleep of remitted bipolar outpatients measured in naturalistic settings is characteristically different from controls: bipolar subjects sleep longer, report longer onset latencies, and display greater variability across nights.

A controlled comparative investigation of psychological treatments for chronic sleep-onset insomnia.

A sample of physician-referred chronic insomniacs was randomly allocated to either progressive relaxation, stimulus control, paradoxical intention, placebo or no treatment conditions. Treatment process and outcome were investigated in terms of mean and standard deviation (night to night variability) measures of sleep pattern and sleep quality. Only active treatments were associated with significant improvement, but the nature of treatment gains varied. In particular, stimulus control improved sleep pattern, whereas relaxation affected perception of sleep quality. All improvements were maintained at 17 month follow-up. Results are discussed with reference to previous research and guidelines are given for clinical practice.

An evaluation of tailored psychological treatment of insomnia

It seems sensible to tailor treatments of insomnia in relation to the presenting characteristics of the sleeper and of the complaint. This report describes the first study formally to examine the comparative effectiveness of tailored and untailored (randomly allocated) treatments. We developed a questionnaire to facilitate the designing of individualized programmes. Results indicated that statistical analysis may underestimate the benefits of tailoring. Measures of clinically significant change, however, suggested that tailored treatment though it may be highly effective, is no more so than stimulus control therapy.

Insomniacs' reported use of CBT components and relationship to long-term clinical outcome

Although there is considerable evidence for the efficacy of non-pharmacological treatment of insomnia, many of the larger trials have delivered CBT in multicomponent format. This makes it impossible to identify critical ingredients responsible for improvement. Furthermore, compliance with home implementation is difficult to ascertain in psychological therapies, and even more so when trying to differentiate across a range of elements. In the present report, 90 patients who had completed 12 month follow-up after participation in a clinical effectiveness study of CBT in general medical practice, responded to a questionnaire asking them about their use of the ten components of the programme. Reports of home use were then entered as predictors of clinical response to treatment. Results indicated that reported home use of stimulus control/sleep restriction was the best predictor of clinical improvement in sleep latency and nighttime wakefulness. Cognitive restructuring also contributed significantly to reduction in wakefulness. In spite of being the most highly endorsed component (by 79% of respondents) use of relaxation did not predict improvement on any variable. Similarly, sleep hygiene was unrelated to sleep pattern change and use of imagery training was modestly predictive of poor response in terms of sleep latency. There are methodological limitations to this type of post hoc analysis, nevertheless, these results being derived from a large patient outcome series raise important issues both for research and clinical practice.