Behavioral and Pharmacological Treatment for Insomnia
Information source: National Institute of Mental Health (NIMH)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sleep Initiation and Maintenance Disorders
Intervention: Cognitive-behavior therapy (Behavioral); zolpidem (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: National Institute of Mental Health (NIMH)
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.
Clinical Details
Official title: Behavioral and Pharmacological Treatment for Insomnia
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
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.
Eligibility
Minimum age: 30 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Laval University, Quebec City, Quebec G1K 7P4, Canada
Additional Information
Starting date: December 2001
Last updated: November 17, 2005
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