Behavioral and Pharmacological Treatment for Insomnia

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease	Intervention/treatment	Phase
Sleep Initiation and Maintenance Disorders	Behavioral: Cognitive-behavior therapy; Drug: zolpidem	Phase 4

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	160 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Behavioral and Pharmacological Treatment for Insomnia
Study Start Date :	December 2001

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	30 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Laval University

National Institute of Mental Health (NIMH)

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Beaulieu-Bonneau S, Ivers H, Guay B, Morin CM. Long-Term Maintenance of Therapeutic Gains Associated With Cognitive-Behavioral Therapy for Insomnia Delivered Alone or Combined With Zolpidem. Sleep. 2017 Mar 1;40(3). doi: 10.1093/sleep/zsx002.

Morin CM, Beaulieu-Bonneau S, Bélanger L, Ivers H, Sánchez Ortuño M, Vallières A, Savard J, Guay B, Mérette C. Cognitive-behavior therapy singly and combined with medication for persistent insomnia: Impact on psychological and daytime functioning. Behav Res Ther. 2016 Dec;87:109-116. doi: 10.1016/j.brat.2016.09.002. Epub 2016 Sep 13.

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 ( U.S. NIH Grant/Contract ); DATR A4-GPS
First Posted:	July 26, 2002
Last Update Posted:	May 21, 2013
Last Verified:	May 2013

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