Zolpidem |
Ambien |
Clinical Trial: Behavioral and Pharmacological Treatment for Insomnia
This study is currently recruiting patients.
|
Purpose
The specific aims of this study are to (a) evaluate the short- and long-term effects of cognitive-behavior therapy (CBT), alone and in combination with medication (zolpidem), for chronic insomnia; (b) compare the efficacy of different maintenance strategies for combining drug and nondrug insomnia therapies to optimize long-term outcomes; and (c) examine the clinical impact of treatment on daytime functioning and psychological well-being.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic | Behavior: Cognitive-behavior therapy Drug: zolpidem | Phase IV |
MedlinePlus related topics: Sleep Disorders
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Expected Total Enrollment: 160
Study start: December 2001
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.
Eligibility
Ages Eligible for Study: 30 Years and above, Genders Eligible for Study: Both
Accepts Healthy Volunteers
Criteria
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
Location and Contact Information
Canada, Quebec
Laval University, Quebec City, Quebec, G1K 7P4, Canada; Recruiting
Charles M. Morin, Ph.D., Principal Investigator
More Information
Record last reviewed: November 2004
Last Updated: November 8, 2004
Record first received: July 24, 2002
ClinicalTrials.gov Identifier: NCT00042146
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005

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