Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

Cognitive-Behavior Therapy for Insomnia

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. Identifier: NCT00869934
Recruitment Status : Completed
First Posted : March 26, 2009
Last Update Posted : July 2, 2013
University of California, Berkeley
Information provided by (Responsible Party):
Charles M. Morin, Laval University

Brief Summary:
Insomnia is a prevalent public health problem affecting large segments of the population on an occasional, recurrent, or chronic basis. Persistent insomnia is associated with impairments in daytime functioning, reduced quality of life, and increased health-care costs. Despite evidence that cognitive-behavior therapy (CBT) is an effective and well accepted treatment for insomnia, a significant proportion of individuals do not respond adequately to this treatment. Hence, there is a need to identify the active therapy components and mechanisms of change in order to develop more effective therapeutic approaches and optimize outcomes. The specific aims of the proposed study are to (a) evaluate the effects of behavioral versus cognitive therapies for insomnia and associated daytime impairment, (b) investigate the mechanisms of change and, (c) examine the impact of insomnia therapies on psychiatric conditions commonly associated with insomnia (anxiety disorders and depression). A sample of 186 adults with chronic insomnia will be recruited from two sites (Laval University and University of California, Berkeley). Participants will be randomly assigned to one of three groups: (a) behavior therapy (BT; n = 62), (b) cognitive therapy (CT; n = 62), or (c) cognitive-behavior therapy (CBT; n = 62). Measures of outcome (sleep/insomnia, daytime functioning) will be administered at baseline, end of treatment, and at 6- and 12-month follow up. Measures of mechanisms of change (maladaptive sleep habits, unhelpful beliefs, sleep-related worry) will be administered at baseline, after the 4th and 8th therapy sessions, and at the end of treatment. It is expected that (1) BT and CBT will be more effective for improving sleep, relative to CT, (2) CT and CBT will be more effective for reducing daytime functional impairment, relative to BT and (3)CT will be more effective than BT in reducing comorbid psychiatric disorders. The public health significance of the proposed study is that it will provide useful information to improve our understanding of insomnia and to enhance efficacy and efficiency of therapeutic approaches for a prevalent and costly health problem. The long-term objective is to contribute to the development and dissemination of evidence-based treatments for chronic insomnia and its common comorbidities.

Condition or disease Intervention/treatment Phase
Chronic Insomnia Other: Cognitive-Behavior Therapy Other: Behavior Therapy Other: Cognitive Therapy Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive-Behavior Therapy for Insomnia: Component Analysis and Treatment
Study Start Date : April 2008
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Arm Intervention/treatment
Active Comparator: 1. Cognitive-Behavior Therapy Other: Cognitive-Behavior Therapy
Sleep restriction, stimulus control, cognitive therapy

Experimental: 2. Behavior Therapy Other: Behavior Therapy
Sleep restriction and stimulus control

Experimental: 3. Cognitive Therapy Other: Cognitive Therapy
Cognitive restructuring therapy

Primary Outcome Measures :
  1. Sleep/insomnia measures: sleep continuity (sleep latency, time awake after sleep onset, total sleep time); insomnia severity index; daytime functioning measures: fatigue, work/social adjustment, quality of life [ Time Frame: pre, post, 6- and 12-month follow ups ]

Secondary Outcome Measures :
  1. psychological/psychiatric measures: severity of anxiety (STAI) and depressive symptoms (BDI); mechanism/process measures [ Time Frame: pre, post, 6- and 12-month follow ups ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Aged 25 years old or older
  • Chronic insomnia(> 6 months)
  • 3 nights or more per week with difficulties falling or staying asleep

Exclusion Criteria:

  • Progressive or unstable medical condition directly interfering with sleep
  • History of psychosis or bipolar disorder
  • Alcohol/substance abuse within the past 12 months
  • Use of medications interfering with sleep
  • Presence of another sleep disorder (e.g., sleep apnea, restless legs syndrome/periodic limb movements)
  • Irregular sleep-wake schedule

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 identifier (NCT number): NCT00869934

Layout table for location information
United States, California
University of California at Berkeley
Berkeley, California, United States, 94704
Canada, Quebec
Laval University
Quebec City, Quebec, Canada, G1K 0A6
Sponsors and Collaborators
Laval University
University of California, Berkeley
Layout table for investigator information
Principal Investigator: Charles M. Morin, PhD Laval University

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Charles M. Morin, Professeur, Laval University Identifier: NCT00869934    
Other Study ID Numbers: R01MH079188-02 ( U.S. NIH Grant/Contract )
First Posted: March 26, 2009    Key Record Dates
Last Update Posted: July 2, 2013
Last Verified: June 2013
Keywords provided by Charles M. Morin, Laval University:
Sleep disorders
Sleep disturbances
Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders