Bipolar Disorder, Insomnia
Conditions
Keywords
Cognitive Behavioral Therapy, CBT-I
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.
Interventions
BEHAVIORALCognitive 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.
Sponsors
St. Olavs Hospital
Norwegian University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in quality of sleep at 8 weeks | 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 | 6 months from end of treatment phase | As assessed by the Insomnia Severity Index (ISI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Variation in sleep registration from baseline to 8 weeks | At 8 weeks | Comparing registrations of sleep by sleep diaries, actigraphs and polysomnography. |
| Variation in sleep registration from baseline to 6 months follow-up | At 6 months | Comparing registrations of sleep by sleep diaries, actigraphs and polysomnography. |
Countries
Norway
Outcome results
None listed