Cognitive Behavioral Therapy for Insomnia in Euthymic Bipolar Disorder

Norwegian University of Science and Technology

Status: Completed

Conditions: Bipolar Disorder; Insomnia

Treatments: Behavioral: Cognitive behavioral therapy for insomnia

Study type: Interventional

Funder types: Other

Identifiers

NCT01704352

2012/1033

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

38 participants in 2 patient groups

CBT-I

Active Comparator group

Description:

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:

Behavioral: Cognitive behavioral therapy for insomnia

Treatment as usual

No Intervention group

Description:

Treatment as usual (TAU) consists of pharmacological and supportive psychosocial treatment according to the needs of the patient.