Better Sleep in Psychiatric Care - Bipolar

Not Applicable

• Conditions: Bipolar Disorder; Sleep Problem
• Interventions: Other: Sleep lectures; Behavioral: Adjusted group CBT-i for Bipolar disorder

• Registration Number: NCT04130529
• Lead Sponsor: Karolinska Institutet

Brief Summary

Cognitive Behavioral Therapy (CBT) is treatment of choice for insomnia. Many patients in psychiatric care have sleep problems including insomnia, but are rarely given the choice to participate in CBT to improve their sleep. Patients with Bipolar disorder is a patient group with high levels of sleep difficulties. Sleep problems in this patient group can be both more general such as insomnia, but can also be related to the Bipolar disorder. Other research groups have studied the use of behaviorally sleep treatments in patients with Bipolar disorder, but more studies are needed. In a previous pilot study, the investigators of the current study developed a CBT protocol that would target sleep problems in this population. The basis was CBT for insomnia (CBT-i), but with more emphasis on achieving sleep promoting behaviors specific to Bipolar patients, for instance techniques that would also alleviate sleep phase problems, (e.g. the systematic use of light and darkness), and techniques to target more general sleep related problems (e.g. difficulties waking up in the morning), that are also common in patients with Bipolar disorder. This treatment was well tolerated and gave moderate effects on insomnia severity in the pilot study. In a naturalistic randomized controlled trial, the investigators now evaluate the effects of this psychological treatment on sleep and Bipolar symptoms in patients at the departments of Affective disorders, Northern Stockholm Psychiatry and Southwest Psychiatry, Stockholm, Sweden.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-10-01
• Study First Submitted: 2019-10-11
• Study First Submitted QC: 2019-10-16
• Study First Posted: 2019-10-17
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-03
• Primary Completion: 2024-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

• Being a patient at the clinics involved in the project
• Experiencing sleep problems (subjective report)
• Being able to participate in a psychological intervention in group format

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Exclusion Criteria

• Night shift work

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleep lectures	Sleep lectures	The control group is offered a series of 3 lectures on sleep during the same time-period.
Adjusted group CBT-i for Bipolar disorder	Adjusted group CBT-i for Bipolar disorder	The experimental group receives group-CBT-i adjusted for Bipolar disorder. This is a version of CBT for insomnia (CBT-i) developed during the pilot phase of this Project. Traditional CBT-i is adjusted for use in the population with Bipolar Disorder. This behavioral intervention adresses not only traditional aspects of insomnia, but also sleep phase problems and other aspects of sleep specifically relevant to the Bipolar population. Treatment is given as 8 weekly group sessions.

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index (ISI)	Changes from base-line to 8 weeks, 5 months and 14 months	7-item, self-rated questionnaire measuring change in insomnia severity. Total score 0-28, higher score indicates more severe sleep problems.

Secondary Outcome Measures

Name	Time	Method
Affective Self Rating Scale (AS-18)	Changes from base-line to 8 weeks, 5 months and 14 months	18-items self-report questionnaire measuring bipolar symptoms. Total score 0-72, subscale for depression (0-36), subscale for mania (0-36). Higher score indicates more severe symptoms.
Actigraphy	Changes from base-line to post 8 weeks.	An actigraph is placed on the participant's arm for one week. It measures participants' arm-movements. An algorithm can be used to estimate sleep from movement data.
WHO Disability Assessment Schedule (WHODAS)	Changes from base-line to 8 weeks, 5 months and 14 months	12-items self-rating questionnaire measuring disability. Total score (0-48), with higher score indicating more severe disability.
Daytime Insomnia Symptoms	Changes from base-line to 8 weeks, 5 months and 14 months	7-item self-rating questionnaire regarding daytime symptoms commonly associated with sleep problems. Total score 0-70, with higher score indicating more severe daytime symptoms.
Sleep habits and behaviors	Changes from base-line to 8 weeks, 5 months and 14 months	Self-rating questionnaire regarding the use of sleep promoting behaviors. The questionnaire was constructed for the larger BSIP project and consists of two parts. The first part includes statements such as "Last week I got out of bed within 15 minutes of waking up" to be answered by number of days the last week this was true (i.e. from 0 to 7). The other part is to be answered on a 6-point Likert scale from "Not at all true" to "Entirely true", with 7 statements like "I get out of bed the same time every morning". No total score is obtained.

Trial Locations

Locations (2)

Department of Affective Disorders, Northern Stockholm Psychiatry; 🇸🇪 Stockholm, Sweden

Department of Affective Disorders, Stockholm Southwest Psychiatry; 🇸🇪 Stockholm, Sweden