Better Sleep in Psychiatric Care - Bipolar

Study Overview
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Brief Summary
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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.

Official Title
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Better Sleep in Psychiatric Care - Bipolar. A Randomized Naturalistic Study of a Psychological Group Treatment for Sleep Problems in Psychiatric Patients With Bipolar Disorder

Conditions
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Sleep Problem, Bipolar Disorder

Intervention / Treatment
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* Behavioral: Adjusted group CBT-i for Bipolar disorder
* Other: Sleep lectures


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Night shift work

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adjusted group CBT-i for Bipolar disorder<br>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. | Behavioral: Adjusted group CBT-i for Bipolar disorder<br>* CBT-i includes sleep scheduling/sleep compression, stimulus control, relaxation, cognitive interventions and sleep hygiene advice. In addition components targeting circadian rhythm problems and problems with very high or very low levels of activity are included.<br>|
| Active Comparator: Sleep lectures<br>The control group is offered a series of 3 lectures on sleep during the same time-period. | Other: Sleep lectures<br>* Lectures on the topic of sleep.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WHO Disability Assessment Schedule (WHODAS) | 12-items self-rating questionnaire measuring disability. Total score (0-48), with higher score indicating more severe disability. | Changes from base-line to 8 weeks, 5 months and 14 months | 
| Affective Self Rating Scale (AS-18) | 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. | Changes from base-line to 8 weeks, 5 months and 14 months | 
| Sleep habits and behaviors | 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. | Changes from base-line to 8 weeks, 5 months and 14 months | 
| Daytime Insomnia Symptoms | 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. | Changes from base-line to 8 weeks, 5 months and 14 months | 
| Actigraphy | 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. | Changes from base-line to post 8 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Behaviour Therapy, Psychological Intervention