Behavioral and Pharmacological Treatment for Insomnia

Laval University

Status and phase

Completed

Phase 4

Conditions

Sleep Initiation and Maintenance Disorders

Treatments

Behavioral: Cognitive-behavior therapy

Drug: zolpidem

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00042146

R01MH060413 (U.S. NIH Grant/Contract)

DATR A4-GPS

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

30+ years old

Volunteers

Accepts Healthy Volunteers

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