The SleepWell Trial
Research type
Research Study
Full title
Treating sleep problems in young people at ultra-high-risk of psychosis: a feasibility randomised controlled trial.
IRAS ID
281235
Contact name
Felicity Waite
Contact email
Sponsor organisation
University of Oxford / Clinical Trials and Research Governance
ISRCTN Number
ISRCTN85601537
Duration of Study in the UK
2 years, 4 months, 1 days
Research summary
Research Summary
New evidence has shown that poor sleep is a causal factor in the development of many mental health problems, including psychosis. Psychosis can have major consequences on psychological wellbeing, physical health, relationships, education, and employment. We would like fewer young people to develop psychosis. As disrupted sleep has proven to be a major causal factor, we have developed a psychological sleep treatment. This has been tested in a small study with 12 young people. The results are highly promising. This trial is a feasibility study, which will test the study procedures and develop the treatment further before we conduct a larger study to test if the sleep treatment works.
Summary of Results
Background and study aims New evidence has shown that poor sleep is a causal factor in the development of many mental health problems, including anxiety, depression, and psychosis. This means it is possible that treating sleep problems might have additional benefits on mental health outcomes in individuals at high risk of mental health problems, such as psychosis. In this feasibility trial, we had two aims: 1) to check the study procedures are acceptable, 2) to see if there is an initial indication of any clinical benefits of the treatment.
Who took part?
40 people aged 14-25 who had difficulties sleeping and other difficulties, including worries about other people or hearing voices took part in the trial.What did the study involve?
Participants were randomly allocated to receive the sleep therapy in addition to their usual care or just continue with their usual care. The sleep therapy involved up to eight meetings with a clinical psychologist (therapist) to work on improving sleep and took place over about 12 weeks. Participants who did not get the sleep therapy were offered a one-off session with a therapist at the end of the study to talk about ideas to improve their sleep. Everyone who took part was asked to meet with a research assessor at the beginning of the study, after 3 months and after 9 months. During these meetings they were asked to complete questionnaires about sleep, how they've been feeling, and any other concerns they may have. At the end of the study 16 participants took part in an interview to talk about their experiences of the study.What did we find?
People were keen to take part in the study. All participants provided data at the follow up assessments. There was a high uptake of therapy (20/21 people completed at least 4 sessions) and the treatment was acceptable to participants. Compared to usual care, the sleep therapy led to large improvements in sleep and wider benefits on other mental health outcomes, including anxiety, depression, and worries about harm from others. These improvements remained at the later follow up (9 months).What are the next steps?
This trial found that it is feasible and acceptable to treat sleep problems in young people at high risk of psychosis: people were keen to take part in the study and to complete the treatment. The sleep therapy may lead to improvements in sleep and other mental health outcomes, including psychosis. A larger trial to test this is now underway: The Sleeping Better trial (information about this trial can be found here: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fdoi.org%252F10.1186%252FISRCTN71800376&data=05%7C02%7Coxforda.rec%40hra.nhs.uk%7Caf0a0f773c3c4c8a0e6308dd0956e801%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638676991036782485%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=TzjTXkaJo4FmzRR%2BWhkk96N8fyf42r3QaaHryJRNChg%3D&reserved=0)./NBTI/NHy5AQ/AQ/a63856de-0c05-43fa-9ce6-cc100dbb08f4/2/-MlZe5Cw8NREC name
South Central - Oxford A Research Ethics Committee
REC reference
20/SC/0281
Date of REC Opinion
17 Aug 2020
REC opinion
Favourable Opinion