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Sleep Disturbance and Bipolar Disorder
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), April 2009
First Received: October 13, 2009   No Changes Posted
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

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Improvements in sleep, emotional functioning and quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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
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 types 1, 2, or Not Otherwise Specified disorder (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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00993850

Contacts
Contact: Rebecca Chandler, D.Phil 510-643-3797 bipolarsleepucb@gmail.com

Locations
United States, California
University of California at Berkeley Recruiting
Berkeley, California, United States, 94720-1650
Contact: Allison Harvey, PhD     510-643-3797        
Sponsors and Collaborators
  More Information

No publications provided

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

Keywords provided by National Institute of Mental Health (NIMH):
Bipolar disorder
Insomnia
Sleep disturbance
Cognitive behavioral therapy

Additional relevant MeSH terms:
Signs and Symptoms
Affective Disorders, Psychotic
Pathologic Processes
Disease
Mental Disorders
Bipolar Disorder
Nervous System Diseases
Mood Disorders
Neurologic Manifestations
Sleep Disorders
Dyssomnias

ClinicalTrials.gov processed this record on November 20, 2009