Cognitive Behavioral Therapy for Insomnia in Euthymic Bipolar Disorder

Study Overview
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Brief Summary
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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.

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

Conditions
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Bipolar Disorder, Insomnia

Intervention / Treatment
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* Behavioral: Cognitive behavioral therapy for insomnia


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CBT-I<br>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<br>* 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.<br>|
| No Intervention: Treatment as usual<br>Treatment as usual (TAU) consists of pharmacological and supportive psychosocial treatment according to the needs of the patient. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Behavioral Therapy, CBT-I