Digital Cognitive Behavioural Therapy for Insomnia versus sleep hygiene education: the impact of improved sleep on functional health, quality of life and psychological well-being. Study protocol for a randomised controlled trial.

BACKGROUND: Previous research has demonstrated that digital CBT (dCBT), delivered via the Internet, is a scalable and effective intervention for treating insomnia in otherwise healthy adults and leads to significant improvements in primary outcomes relating to sleep. The majority of people with insomnia, however, seek help because of the functional impact and daytime consequences of poor sleep, not because of sleep discontinuity per se. Although some secondary analyses suggest that dCBT may have wider health benefits, no adequately powered study has investigated these as a primary endpoint. This study specifically aims to investigate the impact of dCBT for insomnia upon health and well-being, and will investigate sleep-related changes as mediating factors. METHODS/DESIGN: We propose a pragmatic, parallel-group, randomised controlled trial of 1000 community participants meeting criteria for insomnia disorder. In the DIALS trial (Digital Insomnia therapy to Assist your Life as well as your Sleep), participants will be randomised to dCBT delivered using web and/or mobile channels (in addition to treatment as usual (TAU)) or to sleep hygiene education (SHE), comprising a website plus a downloadable booklet (in addition to TAU). Online assessments will take place at 0 (baseline), 4 (mid-treatment), 8 (post-treatment), and 24 (follow-up) weeks. At week 25 all participants allocated to SHE will be offered dCBT, at which point the controlled element of the trial will be complete. Naturalistic follow-up will be invited at weeks 36 and 48. Primary outcomes are functional health and well-being at 8 weeks. Secondary outcomes are mood, fatigue, sleepiness, cognitive function, productivity and social functioning. All main analyses will be carried out at the end of the final controlled follow-up assessments and will be based on the intention-to-treat principle. Further analyses will determine whether observed changes in functional health and well-being are mediated by changes in sleep. The trial is funded by Big Health Ltd. DISCUSSION: This study will be the first large-scale, specifically designed investigation of the health and well-being benefits of CBT for insomnia, and the first examination of the association between CBT-mediated sleep improvement and health status. TRIAL REGISTRATION: ISRCTN60530898 .

The Pros and Cons of Getting Engaged in an Online Social Community Embedded Within Digital Cognitive Behavioral Therapy for Insomnia: Survey Among Users.

BACKGROUND: Sleepio is a proven digital sleep improvement program based on cognitive behavioral therapy techniques. Users have the option to join an online community that includes weekly expert discussions, peer-to-peer discussion forums, and personal message walls. OBJECTIVE: The aim of this study was to conduct an online survey to (1) explore the reasons for deciding to engage with the Sleepio online community, (2) explore the potential benefits arising from engagement with the online community, and (3) identify and describe any problematic issues related to use of the online community. METHODS: We developed an online survey and posted an invitation to the community discussion forum inviting users to participate. In addition, we sent an email invitation to 970 individuals who had previously or were currently working through the Sleepio program to participate in this study. RESULTS: In total, 100 respondents (70/100, 70% female; mean age 51 years, range 26-82 years) completed the online survey. Most respondents had started Sleepio with chronic sleep problems (59/100, 59% up to 10 years; 35/100, 35% >10 years) and had actively engaged with the online community (85/100, 85%) had made a discussion or wall post). At the time of the survey, respondents had used Sleepio for a median of 12 weeks (range from 3 weeks to 2 years). We analyzed responses to the open-ended questions using thematic analysis. This analysis revealed 5 initial drivers for engagement: (1) the desire to connect with people facing similar issues, (2) seeking personalized advice, (3) curiosity, (4) being invited by other members, and (5) wanting to use all available sleep improvement tools. Advantages of engagement included access to continuous support, a reduced sense of isolation, being part of a nonjudgmental community, personalized advice, positive comparisons with others, encouragement to keep going, and altruism. We found 5 potential disadvantages: design and navigation issues, uncertain quality of user-generated content, negative comparisons with others, excessive time commitments, and data privacy concerns. Participants related their community experiences to engagement with the Sleepio program, with many stating it had supported their efforts to improve their sleep, as well as helping with adherence and commitment to the program. Despite some concerns, members regarded the Sleepio community as a valuable resource. CONCLUSIONS: Online communities may be a useful means through which to support long-term engagement with Web-based therapy for insomnia.

Attribution, cognition and psychopathology in persistent insomnia disorder: outcome and mediation analysis from a randomized placebo-controlled trial of online cognitive behavioural therapy.

OBJECTIVES: Insomnia patients complain that mental events keep them awake. This study investigates how cognitive behavioural therapy (CBT) affects such events and considers how attributional, cognitive and psychopathological symptoms may mediate sleep improvement. METHOD: A pragmatic, parallel-group randomized controlled trial of 164 adults (120 F: (mean 49 years (18-78 years)) meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for insomnia disorder, assigned to CBT (n=55; 40 F), imagery relief therapy (IRT placebo; n=55; 42 F), or treatment as usual (TAU; n=54; 38 F), was conducted. CBT/IRT comprised six online sessions delivered by an animated therapist, with automated web/e-mail support. CBT users had access to a moderated community. TAU comprised 'usual care'. Participants completed the Sleep Disturbance Questionnaire (SDQ), Glasgow Content of Thoughts Inventory (GCTI), Depression Anxiety and Stress Scales (DASS) and Sleep Condition Indicator (SCI) at baseline, post treatment and 8-week follow-up. RESULTS: The sample was characterised by mental arousal, notably 'trying too hard' to sleep (SDQ), and by 'sleep and sleeplessness' and 'rehearsal and planning' thoughts (GCTI). Treatment effects were observed for all SDQ domains (e.g., CBT vs. IRT: d=0.76 for 'trying too hard'). CBT was also superior to IRT on the GCTI (e.g., 'rehearsal and planning', d=0.62; 'sleep and sleeplessness', d=0.74). CBT vs. TAU comparisons yielded larger effects, whereas placebo effects (IRT vs. TAU) were small to moderate. Hierarchical regression demonstrated partial mediation of SCI improvement by attributional and cognitive factors (R2 = 21-27%) following CBT. Improvement in sleep efficiency appears to be independent of such factors. CONCLUSION: Online CBT modifies sleep-related attributions, night-time thought content and psychopathology. This process partly mediates improvement in DSM-5-defined insomnia.

The Sleep Condition Indicator: a clinical screening tool to evaluate insomnia disorder.

OBJECTIVE: Describe the development and psychometric validation of a brief scale (the Sleep Condition Indicator (SCI)) to evaluate insomnia disorder in everyday clinical practice. DESIGN: The SCI was evaluated across five study samples. Content validity, internal consistency and concurrent validity were investigated. PARTICIPANTS: 30 941 individuals (71% female) completed the SCI along with other descriptive demographic and clinical information. SETTING: Data acquired on dedicated websites. RESULTS: The eight-item SCI (concerns about getting to sleep, remaining asleep, sleep quality, daytime personal functioning, daytime performance, duration of sleep problem, nights per week having a sleep problem and extent troubled by poor sleep) had robust internal consistency (α≥0.86) and showed convergent validity with the Pittsburgh Sleep Quality Index and Insomnia Severity Index. A two-item short-form (SCI-02: nights per week having a sleep problem, extent troubled by poor sleep), derived using linear regression modelling, correlated strongly with the SCI total score (r=0.90). CONCLUSIONS: The SCI has potential as a clinical screening tool for appraising insomnia symptoms against Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.

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.

The daytime impact of DSM-5 insomnia disorder: comparative analysis of insomnia subtypes from the Great British Sleep Survey.

OBJECTIVE: To profile the daytime impact of the proposed DSM-5 insomnia disorder diagnosis, with and without mental health, physical health, or other sleep disorder comorbidities; to better understand how specific daytime symptom patterns are associated with nighttime sleep in insomnia; and to compare childhood-onset and adulthood-onset insomnia disorder with respect to daytime dysfunction. METHOD: Data were derived from the Great British Sleep Survey (GBSS), an open-access online population survey completed by adults who had a valid postcode and were residents of the United Kingdom. The primary variables of interest were the 6 areas that, according to the proposed DSM-5 criteria, may be impacted in the daytime by insomnia disorder: energy, concentration, relationships, ability to stay awake, mood, and ability to get through work. These variables were compared for those with versus those without insomnia disorder and across 5 insomnia subtypes (difficulty initiating sleep, difficulty maintaining sleep, early morning awakening, a combination of these 3 core symptoms, or nonrestorative sleep). Clinically comorbid insomnia presentations (insomnia disorder with poor mental health/poor physical health/additional sleep disorder symptoms) and insomnia disorder of childhood versus adult onset were also evaluated. RESULTS: A total of 11,129 participants (72% female; mean age = 39 years) completed the GBSS between March 2010 and April 2011, of whom 5,083 screened as having possible insomnia disorder. Compared with those who did not have insomnia disorder, those with insomnia disorder reported greater impairment in all areas of daytime functioning (Cohen d range, 0.68-1.30). The greatest effects reflected negative impact on energy and mood. Participants with a combination of insomnia symptoms tended to be the most impaired (Cohen d range, 0.10-0.23), whereas no consistent differences emerged between the other 4 subtypes. Finally, individuals who had both insomnia disorder and poor mental health were consistently the most impaired comorbid group (Cohen d range, 0.15-0.65), and childhood-onset insomnia disorder had greater daytime impact than adult-onset insomnia disorder (P < .05 for energy; P < .01 for mood, concentration, and getting through work). CONCLUSIONS: The severity of daytime impact of DSM-5 insomnia disorder varies by insomnia type. This finding has implications for the evaluation and management of insomnia in clinical practice.