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Home > "B" Clinical Trials Conditions > Behavioral and Pharmacological Treatment for Insomnia  Behavioral and Pharmacological Treatment for Insomnia
Behavioral and Pharmacological Treatment for Insomnia
For Condition: Sleep Disorders, Intrinsic,Sleep Initiation and Maintenance Disorders
Status: Recruiting
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 30 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 160
Location and Contact Information:
Laval University *Recruiting*
Quebec City, Quebec, G1K 7P4
Canada
Recruiting Charles Morin 418-656-2131
Additional Information:
Study ID Numbers: 60413-01A2;
Study Start Date: December 2001
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00042146
Other Sleep Disorders, Intrinsic Studies:
1. Behavioral and Pharmacological Treatment for Insomnia
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Behavioral and Pharmacological Treatment for Insomnia
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