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

Primary Purpose

Sleep Problem, Bipolar Disorder

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Adjusted group CBT-i for Bipolar disorder
Sleep lectures
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Problem focused on measuring Cognitive Behaviour Therapy, Psychological Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Affective Disorders, Northern Stockholm Psychiatry
  • Department of Affective Disorders, Stockholm Southwest Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adjusted group CBT-i for Bipolar disorder

Sleep lectures

Arm Description

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.

The control group is offered a series of 3 lectures on sleep during the same time-period.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

WHO Disability Assessment Schedule (WHODAS)
12-items self-rating questionnaire measuring disability. Total score (0-48), with higher score indicating more severe disability.
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.
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.
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.
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.

Full Information

First Posted
October 11, 2019
Last Updated
October 2, 2023
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
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1. Study Identification

Unique Protocol Identification Number
NCT04130529
Brief Title
Better Sleep in Psychiatric Care - Bipolar
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Region Stockholm

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Problem, Bipolar Disorder
Keywords
Cognitive Behaviour Therapy, Psychological Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
85 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adjusted group CBT-i for Bipolar disorder
Arm Type
Experimental
Arm Description
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.
Arm Title
Sleep lectures
Arm Type
Active Comparator
Arm Description
The control group is offered a series of 3 lectures on sleep during the same time-period.
Intervention Type
Behavioral
Intervention Name(s)
Adjusted group CBT-i for Bipolar disorder
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sleep lectures
Intervention Description
Lectures on the topic of sleep.
Primary Outcome Measure Information:
Title
Insomnia Severity Index (ISI)
Description
7-item, self-rated questionnaire measuring change in insomnia severity. Total score 0-28, higher score indicates more severe sleep problems.
Time Frame
Changes from base-line to 8 weeks, 5 months and 14 months
Secondary Outcome Measure Information:
Title
WHO Disability Assessment Schedule (WHODAS)
Description
12-items self-rating questionnaire measuring disability. Total score (0-48), with higher score indicating more severe disability.
Time Frame
Changes from base-line to 8 weeks, 5 months and 14 months
Title
Affective Self Rating Scale (AS-18)
Description
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.
Time Frame
Changes from base-line to 8 weeks, 5 months and 14 months
Title
Sleep habits and behaviors
Description
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.
Time Frame
Changes from base-line to 8 weeks, 5 months and 14 months
Title
Daytime Insomnia Symptoms
Description
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.
Time Frame
Changes from base-line to 8 weeks, 5 months and 14 months
Title
Actigraphy
Description
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.
Time Frame
Changes from base-line to post 8 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanna Jernelöv, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Affective Disorders, Northern Stockholm Psychiatry
City
Stockholm
ZIP/Postal Code
11321
Country
Sweden
Facility Name
Department of Affective Disorders, Stockholm Southwest Psychiatry
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30399503
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.
Results Reference
background
PubMed Identifier
25622197
Citation
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.
Results Reference
background
PubMed Identifier
23820830
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.
Results Reference
background

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Better Sleep in Psychiatric Care - Bipolar

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