Combined Behavioral/Pharmacological Therapy for Insomnia
This study will determine how sleeping pills can be combined with nondrug treatments to maximize the benefits of therapy for insomnia...
Brief Summary
Official Title: “Combined Behavioral/Pharmacological Therapy for Insomnia”
This study will determine how sleeping pills can be combined with nondrug treatments to maximize the benefits of therapy for insomnia.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Detailed Clinical Trial Description
Long-term insomnia is a common and significant health problem. Two main treatments, pharmacotherapy and behavioral therapy, have been used to help people with insomnia. Because both treatments have advantages and disadvantages, a combination of these treatments may be a good way to treat insomnia.
During the first 2 weeks of the study, participants keep a sleep log, wear an actigraph (a device that resembles a wristwatch and records activity to help determine when participants are asleep or awake), and complete questionnaires.
Participants are then randomly assigned to receive 6 weeks of behavioral therapy plus zolpidem tartrate (Ambien), behavioral therapy plus placebo, or behavioral therapy alone.
During treatment, participants return to the clinic once a week to turn in their sleep logs, download their actigraph, and complete questionnaires.
After 6 weeks, participants enter the post-treatment phase of the study, which lasts 2 weeks and is identical to the 2-week assessment at the beginning of the study.
After the post-treatment phase, participants enter the follow-up period and are contacted at 3 months, 6 months, and 1 year to complete another 2-week assessment with sleep logs, actigraphy, and questionnaires.
Intervention(s) in this Clinical Trial
- Behavioral: Cognitive-Behavioral Therapy for Insomnia
- Drug: zolpidem tartrate (Ambien)
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Chronic primary insomnia which includes at least 6 months of trouble falling asleep or staying asleep
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 21 Years
Maximum Age for this Clinical Trial: 75 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: National Institute of Mental Health (NIMH) NIH
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00044629
Study ID Number: R01 MH62119
ClinicalTrials.gov Identifier: NCT00044629
Health Authority: United States: Federal Government
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00044629
