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Behavioral and Pharmacological Treatment for Insomnia

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ClinicalTrials.gov Identifier: NCT00042146
Recruitment Status : Completed
First Posted : July 26, 2002
Last Update Posted : May 21, 2013
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Sleep Initiation and Maintenance Disorders Behavioral: Cognitive-behavior therapy Drug: zolpidem Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Behavioral and Pharmacological Treatment for Insomnia
Study Start Date : December 2001

Resource links provided by the National Library of Medicine

Drug Information available for: Zolpidem
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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 ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00042146     History of Changes
Obsolete Identifiers: NCT00218738
Other Study ID Numbers: R01MH060413 ( U.S. NIH Grant/Contract )
First Posted: July 26, 2002    Key Record Dates
Last Update Posted: May 21, 2013
Last Verified: May 2013

Keywords provided by Laval University:
Sleep Disorders
Sleep Deprivation

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action