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Combined Behavioral/Pharmacological Therapy for Insomnia - Article


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Insomnia


Clinical Trial: Combined Behavioral/Pharmacological Therapy for Insomnia

This study is currently recruiting patients.

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)

Purpose

The purpose of this study is to determine how sleeping pills can be combined with nondrug treatments to maximize the benefits of therapy for insomnia.

Condition Treatment or Intervention
Sleep Initiation and Maintenance Disorders
Sleep Deprivation
 Behavior: Cognitive-Behavioral Therapy for Insomnia
 Drug: zolpidem tartrate (Ambien)

MedlinePlus related topics:  Sleep Disorders

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Further Study Details: 

Expected Total Enrollment:  144

Study start: September 2001;  Expected completion: August 2006

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

Ages Eligible for Study:  21 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Chronic primary insomnia which includes at least 6 months of trouble falling asleep or staying asleep

Location and Contact Information


North Carolina
      Duke Sleep Disorders Center, Durham,  North Carolina,  27710,  United States; Recruiting
William K Wohlgemuth, Ph.D.  919-684-4368    wkw@geri.duke.edu 
Victoria Herring  919-681-8392 
William K Wohlgemuth, Ph.D.,  Principal Investigator
Andrew Krystal, M.D.,  Sub-Investigator
Jack D Edinger, Ph.D.,  Sub-Investigator

More Information

Study ID Numbers:  62119-01A1
Record last reviewed:  October 2004
Last Updated:  October 13, 2004
Record first received:  September 3, 2002
ClinicalTrials.gov Identifier:  NCT00044629
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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Page Updated: May 11, 2006
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