Back to resultsSleep Disturbance and Bipolar Disorder
Primary Purpose
Bipolar Disorder, Dyssomnias
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Cognitive behavioral therapy for insomnia
Bipolar education
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar disorder, Insomnia, Sleep disturbance, Cognitive behavioral therapy
Eligibility 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).
Sites / Locations
- University of California at Berkeley
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Bipolar disorder education
Cognitive behavioral therapy
Arm Description
Psychoeducation
Cognitive behavioral therapy for insomnia
Outcomes
Primary Outcome Measures
Improvements in sleep, emotional functioning and quality of life
Secondary Outcome Measures
Full Information
NCT ID
NCT00993850
First Posted
October 13, 2009
Last Updated
April 12, 2013
Sponsor
University of California, Berkeley
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00993850
Brief Title
Sleep Disturbance and Bipolar Disorder
Official Title
A Psychological Intervention for Individuals Who Suffer From Sleep Disturbance and Bipolar Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Berkeley
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Dyssomnias
Keywords
Bipolar disorder, Insomnia, Sleep disturbance, Cognitive behavioral therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bipolar disorder education
Arm Type
Other
Arm Description
Psychoeducation
Arm Title
Cognitive behavioral therapy
Arm Type
Other
Arm Description
Cognitive behavioral therapy for insomnia
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy for insomnia
Intervention Description
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
Other
Intervention Name(s)
Bipolar education
Intervention Description
Psychoeducation
Primary Outcome Measure Information:
Title
Improvements in sleep, emotional functioning and quality of life
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Facility Information:
Facility Name
University of California at Berkeley
City
Berkeley
State/Province
California
ZIP/Postal Code
94720-1650
Country
United States
12. IPD Sharing Statement
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Sleep Disturbance and Bipolar Disorder
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