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Sleep Disturbance and Bipolar Disorder

This study has been completed.
Sponsor:
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

October 13, 2009
April 12, 2013
October 2009
April 2012   (final data collection date for primary outcome measure)
Improvements in sleep, emotional functioning and quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00993850 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Sleep Disturbance and Bipolar Disorder
A Psychological Intervention for Individuals Who Suffer From Sleep Disturbance and Bipolar Disorder

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Bipolar Disorder
  • Dyssomnias
  • 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.
  • Other: Bipolar education
    Psychoeducation
  • Bipolar disorder education
    Psychoeducation
    Intervention: Other: Bipolar education
  • Cognitive behavioral therapy
    Cognitive behavioral therapy for insomnia
    Intervention: Behavioral: Cognitive behavioral therapy for insomnia
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
July 2012
April 2012   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00993850
R34 MH080958, R34MH080958, DAHBR A2-AID
Yes
Allison Harvey, National Institute of Mental Health (NIMH)
University of California, Berkeley
National Institute of Mental Health (NIMH)
Not Provided
University of California, Berkeley
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP