Better Sleep in Psychiatric Care - Bipolar (BSIP-Bipolar)

October 2, 2023 updated by: Susanna Jernelöv, Karolinska Institutet

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 11321
        • Department of Affective Disorders, Northern Stockholm Psychiatry
      • Stockholm, Sweden, 14186
        • Department of Affective Disorders, Stockholm Southwest Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insomnia Severity Index (ISI)
Time Frame: 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.
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)
Time Frame: 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.
Changes from base-line to 8 weeks, 5 months and 14 months
Daytime Insomnia Symptoms
Time Frame: 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.
Changes from base-line to 8 weeks, 5 months and 14 months
Affective Self Rating Scale (AS-18)
Time Frame: 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.
Changes from base-line to 8 weeks, 5 months and 14 months
Sleep habits and behaviors
Time Frame: 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.
Changes from base-line to 8 weeks, 5 months and 14 months
Actigraphy
Time Frame: 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.
Changes from base-line to post 8 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Region Stockholm

Investigators

  • Principal Investigator: Susanna Jernelöv, PhD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

October 11, 2019

First Submitted That Met QC Criteria

October 16, 2019

First Posted (Actual)

October 17, 2019

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/80-31/1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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