Sleep Disturbance and Bipolar Disorder

Phase 3

Completed

• Conditions: Bipolar Disorder; Dyssomnias
• Interventions: Other: Bipolar education; Behavioral: Cognitive behavioral therapy for insomnia

• Registration Number: NCT00993850
• Lead Sponsor: University of California, Berkeley

Brief Summary

The study aims to evaluate a psychological intervention for individuals who suffer from sleep disturbance and bipolar disorder. We are hoping that this treatment will: (1) improve the quality of life of individuals with bipolar disorder who are suffering from sleep disturbance and (2) reduce the risk of, or help prevent, episodes.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-13
• Study First Submitted QC: 2009-10-13
• Study First Posted: 2009-10-14
• Primary Completion: 2012-04
• Study Completion: 2012-07
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-12
• Last Update Posted: 2013-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Bipolar disorder patients with sleep disturbance

1. Meeting Diagnostic and Statistical Manual of Mental Disorders, 4th Text Revision (DSM-IV-TR; APA, 2000) diagnostic criteria for bipolar disorder type 1 (established with the SCID: Structured Clinical Interview for DSM-IV).
2. Being inter-episode throughout the experiment as defined by cutoffs widely used in previous research. On the basis that a drug-free group would likely be unfeasible and unrepresentative, participants will not be excluded on the basis of medications prescribed for bipolar disorder. Comorbidity will be allowed as long as bipolar disorder is the primary diagnosis. However, it is necessary to assess comorbidity for reporting purposes.
3. Participants who have a history of bipolar 1 or suicidal ideation must be under the care of a psychiatrist.
4. Experience distress related to significant sleep disturbance.

Exclusion Criteria

1. Presence of an active and progressive physical illness (e.g., congestive heart failure, cancer, COPD) or neurological degenerative diseases (e.g., dementia, multiple sclerosis) directly related to the onset and course of insomnia;
2. Alcohol or drug abuse (except nicotine) within the past year
3. Active posttraumatic stress disorder
4. Evidence of sleep apnea, restless legs syndrome or periodic limb movements during sleep, or a circadian-based sleep disorder (e.g., delayed or advanced sleep phase syndrome)
5. Patients who pose a current suicidal risk or homicidal risk (assessed by treating psychiatrist) or who have made a suicide attempt within the past 6 months.
6. Pharmacotherapy for sleep defined as the benzodiazepine and non-benzodiazepine hypnotics that operate via the GABA A receptor complex and are FDA approved for the treatment of insomnia, selective melatonin agonists, benzodiazepine anxiolytics and over the counter medications with proven efficacy such as melatonin or herbs such as St. Johns wort.
7. Use of certain medications known to alter sleep (e.g., steroids, theophylline, propranolol, antihistamines that cause drowsiness).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bipolar disorder education	Bipolar education	Psychoeducation
Cognitive behavioral therapy	Cognitive behavioral therapy for insomnia	Cognitive behavioral therapy for insomnia

Primary Outcome Measures

Name	Time	Method
Improvements in sleep, emotional functioning and quality of life	1 year

Trial Locations

Locations (1)

University of California at Berkeley; 🇺🇸 Berkeley, California, United States