Behavioral and Pharmacological Treatment for Insomnia
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Purpose
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 |
|---|---|---|
|
Sleep Initiation and Maintenance Disorders |
Behavioral: Cognitive-behavior therapy Drug: zolpidem |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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.
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations More Information
No publications provided by Laval University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00042146 History of Changes |
| Obsolete Identifiers: | NCT00218738 |
| Other Study ID Numbers: | R01 MH60413, R01MH060413, DATR A4-GPS |
| Study First Received: | July 24, 2002 |
| Last Updated: | May 17, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Laval University:
|
Insomnia Sleep Disorders Sleep Deprivation |
Additional relevant MeSH terms:
|
Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Mental Disorders Zolpidem Hypnotics and Sedatives Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses GABA-A Receptor Agonists GABA Agonists GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013