Cognitive-Behavior Therapy for Insomnia

This study has been completed.
Sponsor:
Collaborator:
University of California, Berkeley
Information provided by (Responsible Party):
Charles M. Morin, Laval University
ClinicalTrials.gov Identifier:
NCT00869934
First received: March 24, 2009
Last updated: June 28, 2013
Last verified: June 2013
  Purpose

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
Chronic Insomnia
Other: Cognitive-Behavior Therapy
Other: Behavior Therapy
Other: Cognitive Therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive-Behavior Therapy for Insomnia: Component Analysis and Treatment

Resource links provided by NLM:


Further study details as provided by Laval University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • psychological/psychiatric measures: severity of anxiety (STAI) and depressive symptoms (BDI); mechanism/process measures [ Time Frame: pre, post, 6- and 12-month follow ups ] [ Designated as safety issue: No ]

Enrollment: 186
Study Start Date: April 2008
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00869934

Locations
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
Investigators
Principal Investigator: Charles M. Morin, PhD Laval University
  More Information

No publications provided

Responsible Party: Charles M. Morin, Professeur, Laval University
ClinicalTrials.gov Identifier: NCT00869934     History of Changes
Other Study ID Numbers: R01 MH079188-02, NIMH
Study First Received: March 24, 2009
Last Updated: June 28, 2013
Health Authority: Canada: Health Canada

Keywords provided by Laval University:
Insomnia
Sleep disorders
Treatment
Sleep disturbances

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014