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      Supported Web-Based Guided Self-Help for Insomnia for Young People Attending Child and Adolescent Mental Health Services: Protocol for a Feasibility Assessment

      , BSc, MSc 1 , , BSc 2 , , BSc 2 , , PhD 1 ,
      (Reviewer), (Reviewer)
      JMIR Research Protocols
      JMIR Publications
      adolescents, mental health, sleep, cognitive behavioral therapy, mobile phone

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          Sleep disturbance in adolescents is common, with up to one-third reporting significant symptoms of insomnia. Research with adults has demonstrated that Web-based cognitive behavioral therapy for insomnia (CBTi) can improve both sleep and mental health. However, research with adolescents is lacking, and we know little about whether CBTi would have similar effects on this younger population.


          This paper summarizes the protocol of a study to assess the feasibility of adding supported Web-based CBTi to the usual care of young people aged 14-17 years attending specialist Child and Adolescent Mental Health Services (CAMHS).


          This is an open trial where we will recruit young people (N=50) aged 14-17 years attending specialist CAMHS with primary or comorbid symptoms of insomnia. In addition to their usual care, young people will be provided with Sleepio, a 6-session, Web-based CBTi self-help program for insomnia. Sleepio teaches a range of techniques including sleep hygiene, relaxation training, stimulus control, sleep restriction, and cognitive techniques that participants will be helped to apply through brief, weekly telephone support calls. Questionnaires and interviews will be completed at baseline and postintervention (8-10 weeks) and will assess sleep, symptoms of depression and anxiety, and acceptability of Sleepio and telephone support.


          Recruitment started in May 2018 and continued until the end of October 2018.


          This study will provide preliminary evidence about whether supported Web-based CBTi is acceptable to young people with mental health problems and about the postintervention effects on sleep and symptoms of anxiety and depression. This information will determine whether a randomized trial to determine the effectiveness of Sleepio should be undertaken.

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          An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database

          Background There is little published guidance as to the sample size required for a pilot or feasibility trial despite the fact that a sample size justification is a key element in the design of a trial. A sample size justification should give the minimum number of participants needed in order to meet the objectives of the trial. This paper seeks to describe the target sample sizes set for pilot and feasibility randomised controlled trials, currently running within the United Kingdom. Methods Data were gathered from the United Kingdom Clinical Research Network (UKCRN) database using the search terms ‘pilot’ and ‘feasibility’. From this search 513 studies were assessed for eligibility of which 79 met the inclusion criteria. Where the data summary on the UKCRN Database was incomplete, data were also gathered from: the International Standardised Randomised Controlled Trial Number (ISRCTN) register; the clinicaltrials.gov website and the website of the funders. For 62 of the trials, it was necessary to contact members of the research team by email to ensure completeness. Results Of the 79 trials analysed, 50 (63.3%) were labelled as pilot trials, 25 (31.6%) feasibility and 14 were described as both pilot and feasibility trials. The majority had two arms (n = 68, 86.1%) and the two most common endpoints were continuous (n = 45, 57.0%) and dichotomous (n = 31, 39.2%). Pilot trials were found to have a smaller sample size per arm (median = 30, range = 8 to 114 participants) than feasibility trials (median = 36, range = 10 to 300 participants). By type of endpoint, across feasibility and pilot trials, the median sample size per arm was 36 (range = 10 to 300 participants) for trials with a dichotomous endpoint and 30 (range = 8 to 114 participants) for trials with a continuous endpoint. Publicly funded pilot trials appear to be larger than industry funded pilot trials: median sample sizes of 33 (range = 15 to 114 participants) and 25 (range = 8 to 100 participants) respectively. Conclusion All studies should have a sample size justification. Not all studies however need to have a sample size calculation. For pilot and feasibility trials, while a sample size justification is important, a formal sample size calculation may not be appropriate. The results in this paper describe the observed sample sizes in feasibility and pilot randomised controlled trials on the UKCRN Database.
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            The effects of improving sleep on mental health (OASIS): a randomised controlled trial with mediation analysis

            Summary Background Sleep difficulties might be a contributory causal factor in the occurrence of mental health problems. If this is true, improving sleep should benefit psychological health. We aimed to determine whether treating insomnia leads to a reduction in paranoia and hallucinations. Methods We did this single-blind, randomised controlled trial (OASIS) at 26 UK universities. University students with insomnia were randomly assigned (1:1) with simple randomisation to receive digital cognitive behavioural therapy (CBT) for insomnia or usual care, and the research team were masked to the treatment. Online assessments took place at weeks 0, 3, 10 (end of therapy), and 22. The primary outcome measures were for insomnia, paranoia, and hallucinatory experiences. We did intention-to-treat analyses. The trial is registered with the ISRCTN registry, number ISRCTN61272251. Findings Between March 5, 2015, and Feb 17, 2016, we randomly assigned 3755 participants to receive digital CBT for insomnia (n=1891) or usual practice (n=1864). Compared with usual practice, the sleep intervention at 10 weeks reduced insomnia (adjusted difference 4·78, 95% CI 4·29 to 5·26, Cohen's d=1·11; p<0·0001), paranoia (−2·22, −2·98 to −1·45, Cohen's d=0·19; p<0·0001), and hallucinations (−1·58, −1·98 to −1·18, Cohen's d=0·24; p<0·0001). Insomnia was a mediator of change in paranoia and hallucinations. No adverse events were reported. Interpretation To our knowledge, this is the largest randomised controlled trial of a psychological intervention for a mental health problem. It provides strong evidence that insomnia is a causal factor in the occurrence of psychotic experiences and other mental health problems. Whether the results generalise beyond a student population requires testing. The treatment of disrupted sleep might require a higher priority in mental health provision. Funding Wellcome Trust.
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              Efficacy of internet-delivered cognitive-behavioral therapy for insomnia - A systematic review and meta-analysis of randomized controlled trials.

              Cognitive-behavioral therapy for insomnia (CBT-I) has been shown efficacious, but the challenge remains to make it available and accessible in order to meet population needs. Delivering CBT-I over the internet (eCBT-I) may be one method to overcome this challenge. The objective of this meta-analysis was to evaluate the efficacy of eCBT-I and the moderating influence of various study characteristics. Two researchers independently searched key electronic databases (1991 to June 2015), selected eligible publications, extracted data, and evaluated methodological quality. Eleven randomized controlled trials examining a total of 1460 participants were included. Results showed that eCBT-I improved insomnia severity, sleep efficiency, subjective sleep quality, wake after sleep onset, sleep onset latency, total sleep time, and number of nocturnal awakenings at post-treatment, with effect sizes (Hedges's g) ranging from 0.21 to 1.09. The effects were comparable to those found for face-to-face CBT-I, and were generally maintained at 4-48 wk follow-up. Moderator analyses showed that longer treatment duration and higher degree of personal clinical support were associated with larger effect sizes, and that larger study dropout in the intervention group was associated with smaller effect sizes. In conclusion, internet-delivered CBT-I appears efficacious and can be considered a viable option in the treatment of insomnia.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                December 2018
                13 December 2018
                : 7
                : 12
                : e11324
                [1 ] Department for Health University of Bath Bath United Kingdom
                [2 ] Child and Family Service Oxford Health National Health Services Foundation Trust Keynsham United Kingdom
                Author notes
                Corresponding Author: Paul Stallard p.stallard@ 123456bath.ac.uk
                Author information
                ©Bethany Cliffe, Abigail Croker, Megan Denne, Paul Stallard. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 13.12.2018.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org.as well as this copyright and license information must be included.

                : 18 June 2018
                : 7 August 2018
                : 16 August 2018
                : 16 August 2018

                adolescents,mental health,sleep,cognitive behavioral therapy,mobile phone


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