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
  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

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00993850

Locations
United States, California
University of California at Berkeley
Berkeley, California, United States, 94720-1650
Sponsors and Collaborators
University of California, Berkeley
  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 April 22, 2014