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Combined Behavioral/Pharmacological Therapy for Insomnia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00044629
First Posted: September 5, 2002
Last Update Posted: September 16, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Duke University
September 3, 2002
September 5, 2002
September 16, 2013
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
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Sleep Initiation and Maintenance Disorders
  • Behavioral: Cognitive-Behavioral Therapy for Insomnia
  • Drug: zolpidem tartrate (Ambien)
  • Drug: Placebo
  • Experimental: Cognitive Behavioral Therapy and Ambien
    Cognitive Behavioral Therapy and Ambien
    Interventions:
    • Behavioral: Cognitive-Behavioral Therapy for Insomnia
    • Drug: zolpidem tartrate (Ambien)
  • Placebo Comparator: Cognitive Behavioral Therapy and Placebo
    Cognitive Behavioral Therapy and Placebo
    Interventions:
    • Behavioral: Cognitive-Behavioral Therapy for Insomnia
    • Drug: Placebo
  • Active Comparator: Cognitive Behavioral Therapy alone (no drug)
    Cognitive Behavioral Therapy alone (no drug)
    Intervention: Behavioral: Cognitive-Behavioral Therapy for Insomnia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
162
August 2006
Not Provided

Inclusion Criteria:

  • be between 21 and 75 years of age
  • have a mean total nocturnal wake time of > 60 min./night
  • have a history of insomnia > 6 months
  • have a history of one or more poor sleep hygiene practices such as taking 3 or more naps/week, varying bed times or wake times by > 2 hrs. from day to day, or routinely lying in bed awake for periods > 30 min

Exclusion Criteria:

  • pregnant women
  • the terminally ill
  • individuals with other medical conditions (e.g. chronic pain disorders, etc.) that compromise sleep
  • individuals with major psychiatric diagnoses
  • persons with hypnotic-dependent insomnia
  • subjects on antidepressants or anxiolytics
  • subjects with evidence of sleep apnea
Sexes Eligible for Study: All
21 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00044629
Pro00011850
R01MH062119 ( U.S. NIH Grant/Contract )
DSIR 83-ATAS
Not Provided
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Duke University
Duke University
National Institute of Mental Health (NIMH)
Not Provided
Duke University
September 2013

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