Cognitive Behavioral Therapy for Insomnia in Euthymic Bipolar Disorder
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|ClinicalTrials.gov Identifier: NCT01704352|
Recruitment Status : Completed
First Posted : October 11, 2012
Last Update Posted : November 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder Insomnia||Behavioral: Cognitive behavioral therapy for insomnia||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cognitive Behavioral Therapy for Insomnia in Euthymic Bipolar Disorder: a Randomized Controlled Trial|
|Actual Study Start Date :||January 2013|
|Actual Primary Completion Date :||August 2018|
|Actual Study Completion Date :||August 2018|
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.
- 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)
- 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)
- Variation in sleep registration from baseline to 8 weeks [ Time Frame: At 8 weeks ]Comparing registrations of sleep by sleep diaries, actigraphs and polysomnography.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704352
|Østmarka Psychiatric Department, St Olavs Hospital|
|Study Director:||Gunnar Morken, PhD Prof||Norwegian University of Science and Technology|