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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

Por: Wilhelmsen-Langeland · A. · Saxvig · I. W. · Gradisar · M. · Vagenes · V. A. · Pallesen · S. · Sorensen · L. · Fasmer · O.-B. · Koenig · J. · Bjorvatn · B. · Osnes · B.
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.

Group bright light therapy compared to treatment as usual for delayed sleep-wake phase disorder among patients in psychiatric care (the SIP trials): a protocol for a pragmatic, randomised controlled trial

Por: Wilhelmsen-Langeland · A. · Osnes · B. · Gradisar · M. · Vagenes · V. A. · Sorensen · L. · Bjorvatn · B. · Fasmer · O.-B. · Koenig · J. · Pallesen · S. · Saxvig · I. W.
Introduction

Circadian rhythm sleep–wake disturbances appear to be prevalent in psychiatric populations and may maintain and exacerbate psychiatric symptoms. Bright light therapy (BLT) is, in addition to exogenous melatonin, the treatment of choice for circadian rhythm disorders like delayed sleep–wake phase disorder (DSWPD) and has yielded promising results in patients with comorbid psychiatric illness. However, such patients are rarely offered this treatment in outpatient clinics. The aim of this randomised controlled trial is to investigate whether group BLT for psychiatric outpatients is superior to treatment as usual (TAU).

Methods and analysis

60 patients with moderate-to-severe psychiatric illness who meet the criteria for DSWPD will be recruited from an outpatient psychiatric clinic in Norway. They will be randomised (1:1) to a group-based Sleep School Wake Up! For Circadian (SSWU-C) programme conjointly with TAU or to TAU while on a wait list for SSWU-C. The SSWU-C will be delivered over four biweekly sessions, each lasting 120 min; hence treatment will last 6 weeks. Assessments will be collected at baseline (T1) and after the intervention (T2). The primary outcome will be changes in sleep timing using measures such as sleep diaries, actigraphy and dim light melatonin onset (DLMO) at 6 weeks postintervention. Secondary outcomes include changes in other sleep metrics, symptoms of depression, anxiety, fatigue, problems with work and social adjustment and well-being. Mixed models will be used for data analyses.

Ethics and dissemination

Ethical approval was granted in 2020 by the Regional Ethics Committee in Western Norway (REK 2020/66304). Findings will be published in peer-reviewed journals and be presented at research conferences and in relevant media. The results may document the need for more specific sleep-directed treatments in psychiatric clinics as a way of treating not only circadian rhythm sleep–wake disorders but also as a treatment to alleviate psychiatric symptoms.

Trial registration number

NCT05177055.

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