Cognitive Behavioral Therapy for Insomnia in Euthymic Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01704352
• Other study ID #: 2012/1033
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: August 2018

Study information

• Verified date: November 2018
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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.

Locations

Country	Name	City	State
Norway	Østmarka Psychiatric Department, St Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in quality of sleep at 8 weeks	As assessed by the Insomnia Severity Index (ISI)	At 8 weeks from randomization
Primary	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	Variation in sleep registration from baseline to 8 weeks	Comparing registrations of sleep by sleep diaries, actigraphs and polysomnography.	At 8 weeks
Secondary	Variation in sleep registration from baseline to 6 months follow-up	Comparing registrations of sleep by sleep diaries, actigraphs and polysomnography.	At 6 months

External Links

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