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Behavioral and Pharmacological Treatment for Insomnia

Sponsor
Laval University (Other)
Overall Status
Completed
CT.gov ID
NCT00042146
Collaborator
National Institute of Mental Health (NIMH) (NIH)
160
Enrollment
1
Location

Study Details

Study Description

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
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

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Behavioral and Pharmacological Treatment for Insomnia
Study Start Date :
Dec 1, 2001

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years and Older
    Sexes Eligible for Study:
    All
    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

    Locations

    Site City State Country Postal Code
    1 Laval University Quebec City Quebec Canada G1K 7P4

    Sponsors and Collaborators

    • Laval University
    • National Institute of Mental Health (NIMH)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00042146
    Other Study ID Numbers:
    • R01MH060413
    • R01MH060413
    • DATR A4-GPS
    • NCT00218738
    First Posted:
    Jul 26, 2002
    Last Update Posted:
    May 21, 2013
    Last Verified:
    May 1, 2013
    Keywords provided by , ,
    Insomnia
    Sleep Disorders
    Sleep Deprivation
    Additional relevant MeSH terms:
    Sleep Initiation and Maintenance Disorders
    Zolpidem

    Study Results

    No Results Posted as of May 21, 2013