Cognitive Behavioral Therapy for Insomnia in Euthymic Bipolar Disorder

Not Applicable

Completed

• Conditions: Insomnia; Bipolar Disorder
• Interventions: Behavioral: Cognitive behavioral therapy for insomnia

• Registration Number: NCT01704352
• Lead Sponsor: Norwegian University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-08
• Study First Submitted QC: 2012-10-08
• Study First Posted: 2012-10-11
• Study Start: 2013-01
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-19
• Last Update Posted: 2018-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT-I	Cognitive behavioral therapy for insomnia	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Østmarka Psychiatric Department, St Olavs Hospital; 🇳🇴 Trondheim, Norway