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Cognitive Behavioral Therapy for Insomnia in Euthymic Bipolar Disorder

Primary Purpose

Bipolar Disorder, Insomnia

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Cognitive behavioral therapy for insomnia
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Cognitive Behavioral Therapy, CBT-I

Eligibility Criteria

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

Inclusion Criteria:

  • Fulfilling criteria for SCID-1-verified bipolar I or II disorder
  • Euthymic, as defined by Montgomery Åsberg Depression Rating Scale (MADRS) not higher than eleven, and Young Mania Rating scale (YMRS) not higher than five.
  • Fulfilling DSM-IV criteria for primary insomnia or insomnia related to another mental disorder, as assessed by the Insomnia Interview Schedule (IIS).

Exclusion Criteria:

  • Being or having been in a defined affective episode the last month before inclusion
  • Hospitalization in the last two months before inclusion
  • Working night shifts
  • Sleep apnea
  • Medical conditions incompatible with participation.
  • Inability to cooperate in the 3-week initial phase before randomization.

Sites / Locations

  • Østmarka Psychiatric Department, St Olavs Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

CBT-I

Treatment as usual

Arm Description

Cognitive behavioral therapy for insomnia (CBT-I) is a multicomponent treatment consisting of sleep restriction therapy, psychoeducation about sleep, stimulus control, stabilizing circadian rhythm and challenging beliefs and perception of sleep.

Treatment as usual (TAU) consists of pharmacological and supportive psychosocial treatment according to the needs of the patient.

Outcomes

Primary Outcome Measures

Change from baseline in quality of sleep at 8 weeks
As assessed by the Insomnia Severity Index (ISI)
Change from baseline in quality of sleep at 6 months follow-up
As assessed by the Insomnia Severity Index (ISI)

Secondary Outcome Measures

Variation in sleep registration from baseline to 8 weeks
Comparing registrations of sleep by sleep diaries, actigraphs and polysomnography.
Variation in sleep registration from baseline to 6 months follow-up
Comparing registrations of sleep by sleep diaries, actigraphs and polysomnography.

Full Information

First Posted
October 8, 2012
Last Updated
November 19, 2018
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01704352
Brief Title
Cognitive Behavioral Therapy for Insomnia in Euthymic Bipolar Disorder
Official Title
Cognitive Behavioral Therapy for Insomnia in Euthymic Bipolar Disorder: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 2013 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients with bipolar disorder suffer from sleep disturbances, even in euthymic phases. Changes in sleep are frequent signs of a new episode of (hypo)mania or depression. Cognitive behavioral therapy for insomnia is an effective treatment for primary insomnia, but has not been introduced to patients with bipolar disorder. The aim is to compare cognitive behavioral therapy added to 'treatment as usual' with just 'treatment as usual'. The investigators hypothesize that cognitive behavioral therapy will improve quality of sleep, stabilize minor mood variations and prevent new mood episodes in euthymic patients with bipolar disorder and insomnia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Insomnia
Keywords
Cognitive Behavioral Therapy, CBT-I

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT-I
Arm Type
Active Comparator
Arm Description
Cognitive behavioral therapy for insomnia (CBT-I) is a multicomponent treatment consisting of sleep restriction therapy, psychoeducation about sleep, stimulus control, stabilizing circadian rhythm and challenging beliefs and perception of sleep.
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Treatment as usual (TAU) consists of pharmacological and supportive psychosocial treatment according to the needs of the patient.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy for insomnia
Intervention Description
CBT-I will be given during 3-6 sessions according to need by two therapists being either psychiatrists or psychologists with clinical experience in CBT-I.
Primary Outcome Measure Information:
Title
Change from baseline in quality of sleep at 8 weeks
Description
As assessed by the Insomnia Severity Index (ISI)
Time Frame
At 8 weeks from randomization
Title
Change from baseline in quality of sleep at 6 months follow-up
Description
As assessed by the Insomnia Severity Index (ISI)
Time Frame
6 months from end of treatment phase
Secondary Outcome Measure Information:
Title
Variation in sleep registration from baseline to 8 weeks
Description
Comparing registrations of sleep by sleep diaries, actigraphs and polysomnography.
Time Frame
At 8 weeks
Title
Variation in sleep registration from baseline to 6 months follow-up
Description
Comparing registrations of sleep by sleep diaries, actigraphs and polysomnography.
Time Frame
At 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Fulfilling criteria for SCID-1-verified bipolar I or II disorder Euthymic, as defined by Montgomery Åsberg Depression Rating Scale (MADRS) not higher than eleven, and Young Mania Rating scale (YMRS) not higher than five. Fulfilling DSM-IV criteria for primary insomnia or insomnia related to another mental disorder, as assessed by the Insomnia Interview Schedule (IIS). Exclusion Criteria: Being or having been in a defined affective episode the last month before inclusion Hospitalization in the last two months before inclusion Working night shifts Sleep apnea Medical conditions incompatible with participation. Inability to cooperate in the 3-week initial phase before randomization.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gunnar Morken, PhD Prof
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Østmarka Psychiatric Department, St Olavs Hospital
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
24433249
Citation
Steinan MK, Krane-Gartiser K, Langsrud K, Sand T, Kallestad H, Morken G. Cognitive behavioral therapy for insomnia in euthymic bipolar disorder: study protocol for a randomized controlled trial. Trials. 2014 Jan 16;15:24. doi: 10.1186/1745-6215-15-24.
Results Reference
derived
Links:
URL
http://www.ntnu.no/sleep-bp
Description
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Cognitive Behavioral Therapy for Insomnia in Euthymic Bipolar Disorder

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