Sleep Disturbance and Bipolar Disorder

NCT ID: NCT00993850

Last Updated: 2013-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2012-07-31

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.

Conditions

Bipolar Disorder; Dyssomnias

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Bipolar disorder education

Psychoeducation

Group Type: OTHER

Bipolar education

Intervention Type: OTHER

Psychoeducation

Cognitive behavioral therapy

Cognitive behavioral therapy for insomnia

Group Type: OTHER

Cognitive behavioral therapy for insomnia

Intervention Type: BEHAVIORAL

Attending 6-10 treatment sessions in one of our interview rooms. The sessions will be offered on a weekly basis. Each session takes approximately 50 minutes.

Interventions

Cognitive behavioral therapy for insomnia

Attending 6-10 treatment sessions in one of our interview rooms. The sessions will be offered on a weekly basis. Each session takes approximately 50 minutes.

Intervention Type: BEHAVIORAL

Bipolar education

Psychoeducation

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of California, Berkeley

OTHER

Sponsor Role: lead

Responsible Party

Allison Harvey

Professor of Clinical Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of California at Berkeley

Berkeley, California, United States

Countries

United States

Other Identifiers

R34MH080958

Identifier Type: NIH

Identifier Source: secondary_id

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DAHBR A2-AID

Identifier Type: -

Identifier Source: secondary_id

R34MH080958

Identifier Type: NIH

Identifier Source: org_study_id

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