NCT00042146

Behavioral and Pharmacological Treatment for Insomnia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (planned)
• Sponsor: Laval University · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Sleep Initiation and Maintenance Disorders

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive-behavior therapy
DRUG	zolpidem

Timeline

• Start date: 2001-12-01
• First posted: 2002-07-26
• Last updated: 2013-05-21

Locations

1 site across 1 country: Canada