Journal article
Treating sleep problems in young people at ultra-high-risk of psychosis: study protocol for a single-blind parallel group randomised controlled feasibility trial (SleepWell)
- Abstract:
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Background: Effective interventions, targeting key contributory causal factors, are needed to prevent the emergence of severe mental health problems in young people. Insomnia is a common clinical issue that is problematic in its own right but that also leads to the development and persistence of psychotic experiences. The implication is that treating sleep problems may prevent the onset of psychosis. We collected initial case series data with 12 young people at ultra-high-risk of psychosis. Post-intervention, there were improvements in sleep, depression, and psychotic experiences. Now we test the feasibility of a randomised controlled trial, with a clinical aim to treat sleep problems and hence reduce depression, psychotic experiences, and prevent transition to psychosis.
Methods and analysis: A randomised controlled feasibility trial will be conducted. Forty patients aged 14-25 years who are at ultra-high-risk of psychosis and have sleep disturbance will be recruited from NHS mental health services. Participants will be randomised to receive either a novel, targeted, youth-focused sleep intervention in addition to usual care or usual care alone. Assessor-blinded assessments will be conducted at baseline, three months (post-intervention) and nine months (follow-up). The eight-session psychological intervention will target the key mechanisms which disrupt sleep: circadian rhythm irregularities, low sleep pressure, and hyperarousal. To gain an in-depth understanding of participants’ views on the acceptability of the intervention and study procedures, 16 participants (n=10 intervention, n=6 control) will take part in qualitative interviews. Analyses will focus on feasibility outcomes (recruitment, retention, and treatment uptake rates) and provide initial confidence interval estimates of intervention effects. Thematic analysis of the qualitative interviews will assess the acceptability of the intervention and trial procedures.
Ethics and dissemination: The trial has received ethical approval from the NHS Health Research Authority. Findings will be disseminated through peer-reviewed publications, conference presentations, and lay networks.
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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- Files:
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(Preview, Version of record, pdf, 434.2KB, Terms of use)
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- Publisher copy:
- 10.1136/bmjopen-2020-045235
Authors
- Publisher:
- BMJ Publishing Group
- Journal:
- BMJ Open More from this journal
- Volume:
- 10
- Issue:
- 11
- Article number:
- e045235
- Publication date:
- 2020-11-10
- Acceptance date:
- 2020-09-28
- DOI:
- ISSN:
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2044-6055
- Language:
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English
- Keywords:
- Pubs id:
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1137572
- Local pid:
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pubs:1137572
- Deposit date:
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2020-10-14
- ARK identifier:
Terms of use
- Copyright holder:
- Waite et al.
- Copyright date:
- 2020
- Rights statement:
- © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
- Licence:
- CC Attribution (CC BY)
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