BSIP-Bipolar: Better Sleep in Psychiatric Care - Bipolar
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Behavioral: Adjusted group CBT-i for Bipolar disorder
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.
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| Active Comparator: Sleep lectures The control group is offered a series of 3 lectures on sleep during the same time-period. |
Other: Sleep lectures
Lectures on the topic of sleep.
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Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Being a patient at the clinics involved in the project
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Experiencing sleep problems (subjective report)
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Being able to participate in a psychological intervention in group format
Exclusion Criteria:
- Night shift work
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Affective Disorders, Northern Stockholm Psychiatry | Stockholm | Sweden | 11321 | |
| 2 | Department of Affective Disorders, Stockholm Southwest Psychiatry | Stockholm | Sweden | 14186 |
Sponsors and Collaborators
- Karolinska Institutet
- Region Stockholm
Investigators
- Principal Investigator: Susanna Jernelöv, PhD, Karolinska Institutet
Study Documents (Full-Text)
None provided.More Information
Publications
- Harvey AG, Soehner AM, Kaplan KA, Hein K, Lee J, Kanady J, Li D, Rabe-Hesketh S, Ketter TA, Neylan TC, Buysse DJ. Treating insomnia improves mood state, sleep, and functioning in bipolar disorder: a pilot randomized controlled trial. J Consult Clin Psychol. 2015 Jun;83(3):564-77. doi: 10.1037/a0038655. Epub 2015 Jan 26.
- Kaplan KA, Harvey AG. Behavioral treatment of insomnia in bipolar disorder. Am J Psychiatry. 2013 Jul;170(7):716-20. doi: 10.1176/appi.ajp.2013.12050708.
- Kaplan KA, Talavera DC, Harvey AG. Rise and shine: A treatment experiment testing a morning routine to decrease subjective sleep inertia in insomnia and bipolar disorder. Behav Res Ther. 2018 Dec;111:106-112. doi: 10.1016/j.brat.2018.10.009. Epub 2018 Oct 27.
- 2018/80-31/1