Sleep Disturbance and Bipolar Disorder
This study has been completed.
Sponsor:
University of California, Berkeley
Collaborator:
Information provided by (Responsible Party):
Allison Harvey, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00993850
First received: October 13, 2009
Last updated: April 12, 2013
Last verified: April 2013
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | A Psychological Intervention for Individuals Who Suffer From Sleep Disturbance and Bipolar Disorder |
Resource links provided by NLM:
Further study details as provided by University of California, Berkeley:
Primary Outcome Measures:
- Improvements in sleep, emotional functioning and quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 52 |
| Study Start Date: | October 2009 |
| Study Completion Date: | July 2012 |
| 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 |
Criteria
Inclusion Criteria:
Bipolar disorder patients with sleep disturbance
- 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).
- 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.
- Participants who have a history of bipolar 1 or suicidal ideation must be under the care of a psychiatrist.
- Experience distress related to significant sleep disturbance.
Exclusion Criteria:
- 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;
- Alcohol or drug abuse (except nicotine) within the past year
- Active posttraumatic stress disorder
- 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)
- 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.
- 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.
- Use of certain medications known to alter sleep (e.g., steroids, theophylline, propranolol, antihistamines that cause drowsiness).
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Allison Harvey, Professor of Clinical Psychology, National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00993850 History of Changes |
| Other Study ID Numbers: | R34 MH080958, R34MH080958, DAHBR A2-AID |
| Study First Received: | October 13, 2009 |
| Last Updated: | April 12, 2013 |
| Health Authority: | United States: Federal Government United States: National Institute of Mental Health |
Keywords provided by University of California, Berkeley:
|
Bipolar disorder Insomnia Sleep disturbance Cognitive behavioral therapy |
Additional relevant MeSH terms:
|
Bipolar Disorder Sleep Disorders Dyssomnias Parasomnias Affective Disorders, Psychotic |
Mood Disorders Mental Disorders Nervous System Diseases Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013