Behavioral and Pharmacological Treatment for Insomnia

This study has been completed.
National Institute of Mental Health (NIMH)
Information provided by:
Laval University Identifier:
First received: July 24, 2002
Last updated: May 17, 2013
Last verified: May 2013
This study will evaluate the long- and short-term effects of cognitive-behavior therapy (CBT), alone and in combination with zolpidem (Ambien®), for chronic insomnia.

Condition Intervention Phase
Sleep Initiation and Maintenance Disorders
Behavioral: Cognitive-behavior therapy
Drug: zolpidem
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Behavioral and Pharmacological Treatment for Insomnia

Further study details as provided by Laval University:

Estimated Enrollment: 160
Study Start Date: December 2001
Detailed Description:

Insomnia is a prevalent health concern which is often associated with functional impairments, reduced quality of life, and increased health-care costs. The proposed study may provide useful information about optimal models for integrating behavioral and pharmacological therapies for the clinical management of insomnia.

Participants are randomly assigned to CBT or CBT plus medication. After the 6-week acute treatment phase, participants enter into a 6-month extended treatment phase. Of those treated with CBT alone initially, responders are randomized to extended CBT or no treatment. Of those receiving the combined CBT plus medication approach initially, responders are randomized to an extended treatment consisting of either CBT plus medication (used on an as needed schedule) or CBT alone (plus medication tapering). Outcome is evaluated across measures of sleep, clinical ratings, and several indices of daytime functioning. The measures are administered at baseline, at the end of the acute and extended treatment phases, and at 6, 12, and 24-month follow-up.


Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion criteria:

  • Subjective complaint of difficulties initiating or maintaining sleep, accompanied by marked distress or daytime impairments due to insomnia
  • Sleep difficulties present 3 nights or more per week and lasting for more than 6 months

Exclusion criteria:

  • Major medical or psychiatric problems
  Contacts and Locations
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Please refer to this study by its identifier: NCT00042146

Canada, Quebec
Laval University
Quebec City, Quebec, Canada, G1K 7P4
Sponsors and Collaborators
Laval University
National Institute of Mental Health (NIMH)
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00042146     History of Changes
Obsolete Identifiers: NCT00218738
Other Study ID Numbers: R01MH060413  DATR A4-GPS 
Study First Received: July 24, 2002
Last Updated: May 17, 2013
Health Authority: United States: Federal Government

Keywords provided by Laval University:
Sleep Disorders
Sleep Deprivation

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Mental Disorders
Nervous System Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders processed this record on May 26, 2016