Combined Behavioral/Pharmacological Therapy for Insomnia
Information source: National Institute of Mental Health (NIMH)
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sleep Initiation and Maintenance Disorders
Intervention: Cognitive-Behavioral Therapy for Insomnia (Behavioral); zolpidem tartrate (Ambien) (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: National Institute of Mental Health (NIMH)
Summary
This study will determine how sleeping pills can be combined with nondrug treatments to
maximize the benefits of therapy for insomnia.
Clinical Details
Official title: Combined Behavioral/Pharmacological Therapy for Insomnia
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Detailed 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.
Eligibility
Minimum age: 21 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Chronic primary insomnia which includes at least 6 months of trouble falling asleep
or staying asleep
Locations and Contacts
Duke Sleep Disorders Center, Durham, North Carolina 27710, United States; Recruiting
William K Wohlgemuth, Ph.D., Phone: 919-684-4368, Email: wkw@geri.duke.edu
Victoria Herring, Phone: 919-681-8392
William K Wohlgemuth, Ph.D., Principal Investigator
Andrew Krystal, M.D., Sub-Investigator
Jack D Edinger, Ph.D., Sub-Investigator
Additional Information
Starting date: September 2001
Ending date: August 2006
Last updated: November 17, 2005
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