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Sponsors and Collaborators: |
Laval University University of California, Berkeley |
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Information provided by: | Laval University |
ClinicalTrials.gov Identifier: | NCT00869934 |
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 | Intervention | Phase |
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Chronic Insomnia |
Other: Cognitive-Behavior Therapy Other: Behavior Therapy Other: Cognitive Therapy |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | Cognitive-Behavior Therapy for Insomnia: Component Analysis and Treatment |
Estimated Enrollment: | 186 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | May 2012 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1. Cognitive-Behavior Therapy: Active Comparator |
Other: Cognitive-Behavior Therapy
Sleep restriction, stimulus control, cognitive therapy
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2. Behavior Therapy: Experimental |
Other: Behavior Therapy
Sleep restriction and stimulus control
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3. Cognitive Therapy: Experimental |
Other: Cognitive Therapy
Cognitive restructuring therapy
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Ages Eligible for Study: | 25 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Manon Lamy | 418 656-2131 ext 12467 | manon.lamy@crulrg.ulaval.ca |
Contact: Charles Morin, PhD | 418 656-2131 ext 6978 |
United States, California | |
University of California at Berkeley | Recruiting |
Berkeley, California, United States, 94704 | |
Contact: Jamie B Rifkin, PhD 510-643-9438 jrifkin@berkeley.edu | |
Principal Investigator: Allison G Harvey, PhD | |
Canada, Quebec | |
Laval University | Recruiting |
Quebec City, Quebec, Canada, G1K 0A6 | |
Contact: Manon Lamy 418 656-2131 ext 12467 manon.lamy@crulrg.ulaval.ca | |
Principal Investigator: Charles M Morin, PhD |
Principal Investigator: | Charles M. Morin, PhD | Laval University |
Responsible Party: | Laval University ( Charles M. Morin ) |
Study ID Numbers: | R01 MH079188-02, NIMH |
Study First Received: | March 24, 2009 |
Last Updated: | March 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00869934 History of Changes |
Health Authority: | Canada: Health Canada |
Sleep Initiation and Maintenance Disorders Mental Disorders Dyssomnias Sleep Disorders Sleep Disorders, Intrinsic |
Sleep Initiation and Maintenance Disorders Mental Disorders Nervous System Diseases |
Sleep Disorders Dyssomnias Sleep Disorders, Intrinsic |