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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00042146 |
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.
Condition | Intervention | Phase |
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Sleep Initiation and Maintenance Disorders |
Behavioral: Cognitive-behavior therapy Drug: zolpidem |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Behavioral and Pharmacological Treatment for Insomnia |
Estimated Enrollment: | 160 |
Study Start Date: | 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.
Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Exclusion criteria:
Study ID Numbers: | R01 MH60413, DATR A4-GPS |
Study First Received: | July 24, 2002 |
Last Updated: | November 17, 2005 |
ClinicalTrials.gov Identifier: | NCT00042146 |
Health Authority: | United States: Federal Government |
Insomnia Sleep Disorders Sleep Deprivation |
Zolpidem Sleep Initiation and Maintenance Disorders Mental Disorders Dyssomnias |
Sleep Disorders Sleep Deprivation Sleep Disorders, Intrinsic |
Nervous System Diseases |