Sleep Disturbance and Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00993850
• Other study ID #: R34MH080958
• Secondary ID: R34MH080958DAHBR
• Status: Completed
• Phase: Phase 3
• First received: October 13, 2009
• Last updated: April 12, 2013
• Start date: October 2009
• Est. completion date: July 2012

Study information

• Verified date: April 2013
• Source: University of California, Berkeley
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: National Institute of Mental Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: July 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Dyssomnias
• Parasomnias
• Sleep Disorders

Intervention

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

Locations

Country	Name	City	State
United States	University of California at Berkeley	Berkeley	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Berkeley	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvements in sleep, emotional functioning and quality of life		1 year	No