Group cognitive behavioural therapy for insomnia compared with treatment as usual for sleep problems in psychiatric care (the SIP trials): a protocol for a pragmatic, randomised controlled trial
Introduction Insomnia is prevalent in psychiatric populations and may contribute to maintain and exacerbate psychiatric symptoms. Cognitive behavioural therapy for insomnia (CBTi) is the treatment of choice also for insomnia comorbid to psychiatric illness. However, patients are rarely offered CBTi...
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BMJ Publishing Group
2025-04-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/4/e090997.full |
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| author | Bjørn Bjorvatn Ståle Pallesen Ane Wilhelmsen-Langeland Ingvild West Saxvig Michael Gradisar Veronika Alice Vågenes Lin Sørensen Ole-Bernt Fasmer Julian Koenig Berge Osnes |
| author_facet | Bjørn Bjorvatn Ståle Pallesen Ane Wilhelmsen-Langeland Ingvild West Saxvig Michael Gradisar Veronika Alice Vågenes Lin Sørensen Ole-Bernt Fasmer Julian Koenig Berge Osnes |
| author_sort | Bjørn Bjorvatn |
| collection | DOAJ |
| description | Introduction Insomnia is prevalent in psychiatric populations and may contribute to maintain and exacerbate psychiatric symptoms. Cognitive behavioural therapy for insomnia (CBTi) is the treatment of choice also for insomnia comorbid to psychiatric illness. However, patients are rarely offered CBTi in psychiatric outpatient clinics. The aim of this randomised controlled trial is to investigate whether CBTi delivered in groups in a psychiatric outpatient clinic is superior to treatment as usual (TAU).Methods and analysis In the Sleep in Psychiatric Care trial, 60 patients with moderate to severe psychiatric illness who meet the criteria for insomnia disorder will be recruited from an outpatient psychiatric clinic in Norway. The patients will be randomised (1:1) either to group-based CBTi (Sleep School Wake Up for Insomnia; SSWU-I) or to a wait list (WL) while they are all receiving TAU for their psychiatric disorder. SSWU-I will comprise five bi-weekly sessions, each lasting 120 min, hence the treatment period is 8 weeks. Assessment will be conducted at baseline (T1) and after 8 weeks (T2). The primary outcome will be self-rated insomnia symptoms using the Insomnia Severity Index and the Bergen Insomnia Scale. Secondary outcomes include measures of symptoms of dysfunctional beliefs and attitudes about sleep, depression, anxiety, fatigue, problems with work and social adjustment and well-being. Mixed model analyses will be conducted to test the hypotheses.Ethics and dissemination Ethical approval has been granted by the Regional Committee for Medical and Health Research Ethics, in Western Norway (REK 2020/66304). Findings will be published in peer-reviewed journals and presented at research conferences and in relevant media. The results may document the need for specific sleep-directed treatments in psychiatric clinics as a way of treating insomnia disorder as well as to alleviate psychiatric symptoms.Trial registration number NCT04463498. |
| format | Article |
| id | doaj-art-eca516aa6cc04c6687f876227bac55b6 |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-eca516aa6cc04c6687f876227bac55b62025-08-20T03:11:54ZengBMJ Publishing GroupBMJ Open2044-60552025-04-0115410.1136/bmjopen-2024-090997Group cognitive behavioural therapy for insomnia compared with treatment as usual for sleep problems in psychiatric care (the SIP trials): a protocol for a pragmatic, randomised controlled trialBjørn Bjorvatn0Ståle Pallesen1Ane Wilhelmsen-Langeland2Ingvild West Saxvig3Michael Gradisar4Veronika Alice Vågenes5Lin Sørensen6Ole-Bernt Fasmer7Julian Koenig8Berge Osnes9Norwegian Competence Center for Sleep Disorders, Haukeland University Hospital, Bergen, NorwayDepartment of Psychosocial Science, University of Bergen, Bergen, NorwayDivision of Psychiatry, Haukeland University Hospital, Bergen, NorwayNorwegian Competence Center for Sleep Disorders, Haukeland University Hospital, Bergen, NorwayWink Sleep Pty Ltd, Adelaide, South Australia, AustraliaDivision of Psychiatry, Haukeland University Hospital, Bergen, NorwayDepartment of Biological and Medical Psychology, University of Bergen, Bergen, NorwayDepartment of Clinical Medicine, University of Bergen, Bergen, NorwayDepartment of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University of Cologne, Koln, Nordrhein-Westfalen, GermanyDepartment of Clinical Psychology, University of Bergen, Bergen, NorwayIntroduction Insomnia is prevalent in psychiatric populations and may contribute to maintain and exacerbate psychiatric symptoms. Cognitive behavioural therapy for insomnia (CBTi) is the treatment of choice also for insomnia comorbid to psychiatric illness. However, patients are rarely offered CBTi in psychiatric outpatient clinics. The aim of this randomised controlled trial is to investigate whether CBTi delivered in groups in a psychiatric outpatient clinic is superior to treatment as usual (TAU).Methods and analysis In the Sleep in Psychiatric Care trial, 60 patients with moderate to severe psychiatric illness who meet the criteria for insomnia disorder will be recruited from an outpatient psychiatric clinic in Norway. The patients will be randomised (1:1) either to group-based CBTi (Sleep School Wake Up for Insomnia; SSWU-I) or to a wait list (WL) while they are all receiving TAU for their psychiatric disorder. SSWU-I will comprise five bi-weekly sessions, each lasting 120 min, hence the treatment period is 8 weeks. Assessment will be conducted at baseline (T1) and after 8 weeks (T2). The primary outcome will be self-rated insomnia symptoms using the Insomnia Severity Index and the Bergen Insomnia Scale. Secondary outcomes include measures of symptoms of dysfunctional beliefs and attitudes about sleep, depression, anxiety, fatigue, problems with work and social adjustment and well-being. Mixed model analyses will be conducted to test the hypotheses.Ethics and dissemination Ethical approval has been granted by the Regional Committee for Medical and Health Research Ethics, in Western Norway (REK 2020/66304). Findings will be published in peer-reviewed journals and presented at research conferences and in relevant media. The results may document the need for specific sleep-directed treatments in psychiatric clinics as a way of treating insomnia disorder as well as to alleviate psychiatric symptoms.Trial registration number NCT04463498.https://bmjopen.bmj.com/content/15/4/e090997.full |
| spellingShingle | Bjørn Bjorvatn Ståle Pallesen Ane Wilhelmsen-Langeland Ingvild West Saxvig Michael Gradisar Veronika Alice Vågenes Lin Sørensen Ole-Bernt Fasmer Julian Koenig Berge Osnes Group cognitive behavioural therapy for insomnia compared with treatment as usual for sleep problems in psychiatric care (the SIP trials): a protocol for a pragmatic, randomised controlled trial BMJ Open |
| title | Group cognitive behavioural therapy for insomnia compared with treatment as usual for sleep problems in psychiatric care (the SIP trials): a protocol for a pragmatic, randomised controlled trial |
| title_full | Group cognitive behavioural therapy for insomnia compared with treatment as usual for sleep problems in psychiatric care (the SIP trials): a protocol for a pragmatic, randomised controlled trial |
| title_fullStr | Group cognitive behavioural therapy for insomnia compared with treatment as usual for sleep problems in psychiatric care (the SIP trials): a protocol for a pragmatic, randomised controlled trial |
| title_full_unstemmed | Group cognitive behavioural therapy for insomnia compared with treatment as usual for sleep problems in psychiatric care (the SIP trials): a protocol for a pragmatic, randomised controlled trial |
| title_short | Group cognitive behavioural therapy for insomnia compared with treatment as usual for sleep problems in psychiatric care (the SIP trials): a protocol for a pragmatic, randomised controlled trial |
| title_sort | group cognitive behavioural therapy for insomnia compared with treatment as usual for sleep problems in psychiatric care the sip trials a protocol for a pragmatic randomised controlled trial |
| url | https://bmjopen.bmj.com/content/15/4/e090997.full |
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