We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Combined Behavioral/Pharmacological Therapy for Insomnia

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.
 
ClinicalTrials.gov Identifier: NCT00044629
Recruitment Status : Completed
First Posted : September 5, 2002
Last Update Posted : September 16, 2013
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Duke University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study will determine how sleeping pills can be combined with nondrug treatments to maximize the benefits of therapy for insomnia.

Condition or disease Intervention/treatment Phase
Sleep Initiation and Maintenance Disorders Behavioral: Cognitive-Behavioral Therapy for Insomnia Drug: zolpidem tartrate (Ambien) Drug: Placebo Phase 2

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Combined Behavioral/Pharmacological Therapy for Insomnia
Study Start Date : September 2001
Study Completion Date : August 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Cognitive Behavioral Therapy and Ambien
Cognitive Behavioral Therapy and Ambien
 Behavioral: Cognitive-Behavioral Therapy for Insomnia
Drug: zolpidem tartrate (Ambien)
Placebo Comparator: Cognitive Behavioral Therapy and Placebo
Cognitive Behavioral Therapy and Placebo
 Behavioral: Cognitive-Behavioral Therapy for Insomnia
Drug: Placebo
Active Comparator: Cognitive Behavioral Therapy alone (no drug)
Cognitive Behavioral Therapy alone (no drug)
 Behavioral: Cognitive-Behavioral Therapy for Insomnia


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00044629


Locations
Layout table for location information
United States, North Carolina
Duke Sleep Disorders Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Institute of Mental Health (NIMH)
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00044629    
Other Study ID Numbers: Pro00011850
R01MH062119 ( U.S. NIH Grant/Contract )
DSIR 83-ATAS
First Posted: September 5, 2002    Key Record Dates
Last Update Posted: September 16, 2013
Last Verified: September 2013
Keywords provided by Duke University:
Sleep Deprivation
Insomnia
Sleep Disorders
Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Zolpidem
Sleep Aids, Pharmaceutical
 Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action