Better Sleep in Psychiatric Care - Bipolar

Bipolar Disorder Clinical Trial

— BSIP-Bipolar  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04130529
• Other study ID #: 2018/80-31/1
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: June 2025

Study information

• Verified date: October 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 85
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Dyssomnias
• Parasomnias
• Sleep Problem

Intervention

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.

Other:
• Sleep lectures
Lectures on the topic of sleep.

Locations

Country	Name	City	State
Sweden	Department of Affective Disorders, Northern Stockholm Psychiatry	Stockholm
Sweden	Department of Affective Disorders, Stockholm Southwest Psychiatry	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Region Stockholm

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.