Cognitive Behavioral Therapy for Insomnia in Euthymic Bipolar Disorder

NCT01704352 | Completed

• 1 other identifier: 2012/1033
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder; Insomnia

Keywords

Cognitive Behavioral Therapy; CBT-I

Outcome Measures

Primary Outcomes (2)

• Change from baseline in quality of sleep at 8 weeks

  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

  As assessed by the Insomnia Severity Index (ISI)

  6 months from end of treatment phase

Secondary Outcomes (2)

• Variation in sleep registration from baseline to 8 weeks

  At 8 weeks

• Variation in sleep registration from baseline to 6 months follow-up

  At 6 months

Study Arms (2)

CBT-I

ACTIVE COMPARATOR

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

Treatment as usual

NO INTERVENTION

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

Interventions

Cognitive behavioral therapy for insomnia BEHAVIORAL

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.

CBT-I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Working night shifts
• Sleep apnea
• Medical conditions incompatible with participation.
• Inability to cooperate in the 3-week initial phase before randomization.

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator

Study Sites (1)

Østmarka Psychiatric Department, St Olavs Hospital

Trondheim, Norway

Location

Related Publications (1)

• 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.

  PMID: 24433249 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Bipolar Disorder; Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Gunnar Morken, PhD Prof

  Norwegian University of Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2012
• First Posted: October 11, 2012
• Study Start: January 1, 2013
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: November 20, 2018

Record last verified: 2018-11

Locations

NO (1)