Combined Behavioral/Pharmacological Therapy for Insomnia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2005 by National Institute of Mental Health (NIMH).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00044629
First received: September 3, 2002
Last updated: October 5, 2010
Last verified: May 2005

September 3, 2002
October 5, 2010
September 2001
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Complete list of historical versions of study NCT00044629 on ClinicalTrials.gov Archive Site
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Combined Behavioral/Pharmacological Therapy for Insomnia
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.

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.

Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Sleep Initiation and Maintenance Disorders
  • Behavioral: Cognitive-Behavioral Therapy for Insomnia
  • Drug: zolpidem tartrate (Ambien)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
144
August 2006
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Inclusion Criteria:

  • Chronic primary insomnia which includes at least 6 months of trouble falling asleep or staying asleep
Both
21 Years to 75 Years
No
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United States
 
NCT00044629
R01 MH62119, DSIR 83-ATAS
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National Institute of Mental Health (NIMH)
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National Institute of Mental Health (NIMH)
May 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP