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OpenTrials
Completed

NCT Number: NCT00993850

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of California at Berkeley

Berkeley, California, 94720-1650, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Cognitive Behavioral Therapy for Insomnia

Behavioral

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.

Bipolar education

Other

Psychoeducation

Primary outcomes

  1. Improvements in sleep, emotional functioning and quality of life

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of California, Berkeley

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

A Psychological Intervention for Individuals Who Suffer From Sleep Disturbance and Bipolar Disorder

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Oct 14, 2009
Registry last updated
Apr 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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