NCT00993850

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2009

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 14, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

April 16, 2013

Status Verified

April 1, 2013

Enrollment Period

2.5 years

First QC Date

October 13, 2009

Last Update Submit

April 12, 2013

Conditions

Bipolar DisorderDyssomnias

Keywords

Bipolar disorderInsomniaSleep disturbanceCognitive behavioral therapy

Outcome Measures

Primary Outcomes (1)

  • Improvements in sleep, emotional functioning and quality of life

    1 year

Study Arms (2)

Bipolar disorder education

OTHER

Psychoeducation

Other: Bipolar education

Cognitive behavioral therapy

OTHER

Cognitive behavioral therapy for insomnia

Behavioral: Cognitive behavioral therapy for insomnia

Interventions

Cognitive behavioral therapy for insomniaBEHAVIORAL

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.

Cognitive behavioral therapy
Bipolar educationOTHER

Psychoeducation

Bipolar disorder education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California at Berkeley

Berkeley, California, 94720-1650, United States

Location

MeSH Terms

Conditions

Bipolar DisorderDyssomniasSleep Initiation and Maintenance DisordersParasomnias

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersSleep Wake DisordersNervous System DiseasesSleep Disorders, Intrinsic

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Psychology

Study Record Dates

First Submitted

October 13, 2009

First Posted

October 14, 2009

Study Start

October 1, 2009

Primary Completion

April 1, 2012

Study Completion

July 1, 2012

Last Updated

April 16, 2013

Record last verified: 2013-04

Locations

US(1)