Behavioral and Pharmacological Treatment for Insomnia

This study has been completed.

Sponsor:

Collaborator:

National Institute of Mental Health (NIMH)

Information provided by:

Laval University

ClinicalTrials.gov Identifier:

NCT00042146

First received: July 24, 2002

Last updated: May 17, 2013

Last verified: May 2013

History of Changes

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

Resource links provided by NLM:

Drug Information available for: Zolpidem

U.S. FDA Resources

Further study details as provided by Laval University:


Estimated Enrollment:	160
Study Start Date:	December 2001

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


Ages Eligible for Study:	30 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00042146

Locations


Canada, Quebec
Laval University
Quebec City, Quebec, Canada, G1K 7P4

Sponsors and Collaborators

Laval University

National Institute of Mental Health (NIMH)

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Morin CM, Vallières A, Guay B, Ivers H, Savard J, Mérette C, Bastien C, Baillargeon L. Cognitive behavioral therapy, singly and combined with medication, for persistent insomnia: a randomized controlled trial. JAMA. 2009 May 20;301(19):2005-15. doi: 10.1001/jama.2009.682.


ClinicalTrials.gov Identifier:	NCT00042146 History of Changes
Obsolete Identifiers:	NCT00218738
Other Study ID Numbers:	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 Wake Disorders Nervous System Diseases Mental Disorders Zolpidem Hypnotics and Sedatives	Central Nervous System Depressants Physiological Effects of Drugs GABA-A Receptor Agonists GABA Agonists GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 29, 2016

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