Behavioral and Pharmacological Treatment 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. |
ClinicalTrials.gov Identifier: NCT00042146 |
Recruitment Status :
Completed
First Posted : July 26, 2002
Last Update Posted : May 21, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sleep Initiation and Maintenance Disorders | Behavioral: Cognitive-behavior therapy Drug: zolpidem | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
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 |


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.
Ages Eligible for Study: | 30 Years and older (Adult, Older Adult) |
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

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 |
ClinicalTrials.gov Identifier: | NCT00042146 |
Obsolete Identifiers: | NCT00218738 |
Other Study ID Numbers: |
R01MH060413 ( U.S. NIH Grant/Contract ) R01MH060413 ( U.S. NIH Grant/Contract ) DATR A4-GPS |
First Posted: | July 26, 2002 Key Record Dates |
Last Update Posted: | May 21, 2013 |
Last Verified: | May 2013 |
Insomnia Sleep Disorders Sleep Deprivation |
Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases Mental Disorders Zolpidem Sleep Aids, Pharmaceutical |
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 |