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Sleep Disturbance and Bipolar Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00993850
First Posted: October 14, 2009
Last Update Posted: April 16, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Allison Harvey, National Institute of Mental Health (NIMH)
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 Allison Harvey, National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Improvements in sleep, emotional functioning and quality of life [ Time Frame: 1 year ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00993850


Locations
United States, California
University of California at Berkeley
Berkeley, California, United States, 94720-1650
Sponsors and Collaborators
University of California, Berkeley
National Institute of Mental Health (NIMH)
  More Information

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: R34MH080958 ( U.S. NIH Grant/Contract )
DAHBR A2-AID
First Submitted: October 13, 2009
First Posted: October 14, 2009
Last Update Posted: April 16, 2013
Last Verified: April 2013

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

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Dyssomnias
Sleep Wake Disorders
Parasomnias
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms


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