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Behavioral and Pharmacological Treatment for Insomnia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00042146
Recruitment Status : Completed
First Posted : July 26, 2002
Last Update Posted : May 21, 2013
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by:
Laval University

Tracking Information
First Submitted Date  ICMJE July 24, 2002
First Posted Date  ICMJE July 26, 2002
Last Update Posted Date May 21, 2013
Study Start Date  ICMJE December 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00042146 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Behavioral and Pharmacological Treatment for Insomnia
Official Title  ICMJE Behavioral and Pharmacological Treatment for Insomnia
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sleep Initiation and Maintenance Disorders
Intervention  ICMJE
  • Behavioral: Cognitive-behavior therapy
  • Drug: zolpidem
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
160
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00042146
Other Study ID Numbers  ICMJE R01MH060413( U.S. NIH Grant/Contract )
R01MH060413 ( U.S. NIH Grant/Contract )
DATR A4-GPS
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Laval University
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE Not Provided
PRS Account Laval University
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP