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| Sponsor: | National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00993850 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bipolar Disorder Dyssomnias |
Behavioral: Cognitive behavioral therapy for insomnia Other: Bipolar education |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Psychological Intervention for Individuals Who Suffer From Sleep Disturbance and Bipolar Disorder |
| Estimated Enrollment: | 84 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Bipolar disorder education
Psychoeducation
|
Other: Bipolar education
Psychoeducation
|
|
Cognitive behavioral therapy
Cognitive behavioral therapy for insomnia
|
Behavioral: 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Bipolar disorder patients with sleep disturbance
Exclusion Criteria:
Contacts and Locations| Contact: Rebecca Chandler, D.Phil | 510-643-3797 | bipolarsleepucb@gmail.com |
| United States, California | |
| University of California at Berkeley | Recruiting |
| Berkeley, California, United States, 94720-1650 | |
| Contact: Allison Harvey, PhD 510-643-3797 | |
More Information
| Responsible Party: | UC Berkeley ( Allison Harvey ) |
| Study ID Numbers: | R34 MH080958, DAHBR A2-AID |
| Study First Received: | October 13, 2009 |
| Last Updated: | October 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00993850 History of Changes |
| Health Authority: | United States: Federal Government; United States: National Institute of Mental Health |
|
Bipolar disorder Insomnia Sleep disturbance Cognitive behavioral therapy |
|
Signs and Symptoms Affective Disorders, Psychotic Pathologic Processes Disease Mental Disorders Bipolar Disorder |
Nervous System Diseases Mood Disorders Neurologic Manifestations Sleep Disorders Dyssomnias |