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| Name | Class |
|---|---|
| St. Olavs Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Treatment as usual | No Intervention | Treatment as usual (TAU) consists of pharmacological and supportive psychosocial treatment according to the needs of the patient. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gunnar Morken, PhD Prof | Norwegian University of Science and Technology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Østmarka Psychiatric Department, St Olavs Hospital | Trondheim | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24433249 | Derived | 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. |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Comparing registrations of sleep by sleep diaries, actigraphs and polysomnography.
| At 6 months |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |