Cognitive Behavioral Therapy for Insomnia in Euthymic Bipolar Disorder

November 19, 2018 updated by: Norwegian University of Science and Technology

Cognitive Behavioral Therapy for Insomnia in Euthymic Bipolar Disorder: a Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

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

  • Norway
      • Trondheim, Norway
        • Østmarka Psychiatric Department, St Olavs Hospital

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

Genders Eligible for Study

All

Description

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.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CBT-I
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.
Behavioral: Cognitive behavioral therapy for insomnia
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.
No Intervention: Treatment as usual
Treatment as usual (TAU) consists of pharmacological and supportive psychosocial treatment according to the needs of the patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in quality of sleep at 8 weeks
Time Frame: At 8 weeks from randomization
As assessed by the Insomnia Severity Index (ISI)
At 8 weeks from randomization
Change from baseline in quality of sleep at 6 months follow-up
Time Frame: 6 months from end of treatment phase
As assessed by the Insomnia Severity Index (ISI)
6 months from end of treatment phase

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation in sleep registration from baseline to 8 weeks
Time Frame: At 8 weeks
Comparing registrations of sleep by sleep diaries, actigraphs and polysomnography.
At 8 weeks
Variation in sleep registration from baseline to 6 months follow-up
Time Frame: At 6 months
Comparing registrations of sleep by sleep diaries, actigraphs and polysomnography.
At 6 months

Collaborators and Investigators

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

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital

Investigators

  • Study Director: Gunnar Morken, PhD Prof, Norwegian University of Science and Technology

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

Helpful Links

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)

January 1, 2013

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

October 8, 2012

First Submitted That Met QC Criteria

October 8, 2012

First Posted (Estimate)

October 11, 2012

Study Record Updates

Last Update Posted (Actual)

November 20, 2018

Last Update Submitted That Met QC Criteria

November 19, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/1033

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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