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)
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 psyc...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2020-11-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/11/e045235.full |
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| author | Apostolos Tsiachristas Daniel Freeman Thomas Kabir Felicity Waite Louise Johns Jill Mollison Ariane Petit Emma Černis Daniel Maughan |
| author_facet | Apostolos Tsiachristas Daniel Freeman Thomas Kabir Felicity Waite Louise Johns Jill Mollison Ariane Petit Emma Černis Daniel Maughan |
| author_sort | Apostolos Tsiachristas |
| collection | DOAJ |
| description | 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 to 25 years who are at ultra-high-risk of psychosis and have sleep disturbance will be recruited from National Health Service (NHS) mental health services. Participants will be randomised to receive either a novel, targeted, youth-focussed sleep intervention in addition to usual care or usual care alone. Assessor-blinded assessments will be conducted at baseline, 3 months (post-intervention) and 9 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 CI 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.Trial registration number ISRCTN85601537. |
| format | Article |
| id | doaj-art-434c898e0d0e4518892ee2a67a91a4f8 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-11-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-434c898e0d0e4518892ee2a67a91a4f82024-11-25T08:55:09ZengBMJ Publishing GroupBMJ Open2044-60552020-11-01101110.1136/bmjopen-2020-045235Treating sleep problems in young people at ultra-high-risk of psychosis: study protocol for a single-blind parallel group randomised controlled feasibility trial (SleepWell)Apostolos Tsiachristas0Daniel Freeman1Thomas Kabir2Felicity Waite3Louise Johns4Jill Mollison5Ariane Petit6Emma Černis7Daniel Maughan8Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, Oxfordshire, UK2 Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK1 Department of Experimental Psychology, University of Oxford, Oxford, UKDepartment of Psychiatry, University of Oxford, Oxford, UKDepartment of Psychiatry, University of Oxford, Oxford, UKNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK1 Department of Psychiatry, Warneford Hospital, University of Oxford, Oxford, UKDepartment of Psychiatry, University of Oxford, Oxford, UK3 Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UKBackground 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 to 25 years who are at ultra-high-risk of psychosis and have sleep disturbance will be recruited from National Health Service (NHS) mental health services. Participants will be randomised to receive either a novel, targeted, youth-focussed sleep intervention in addition to usual care or usual care alone. Assessor-blinded assessments will be conducted at baseline, 3 months (post-intervention) and 9 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 CI 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.Trial registration number ISRCTN85601537.https://bmjopen.bmj.com/content/10/11/e045235.full |
| spellingShingle | Apostolos Tsiachristas Daniel Freeman Thomas Kabir Felicity Waite Louise Johns Jill Mollison Ariane Petit Emma Černis Daniel Maughan 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) BMJ Open |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/10/11/e045235.full |
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