Combined Behavioral/Pharmacological Therapy for Insomnia
Recruitment status was Recruiting
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Purpose
This study will determine how sleeping pills can be combined with nondrug treatments to maximize the benefits of therapy for insomnia.
| Condition | Intervention |
|---|---|
|
Sleep Initiation and Maintenance Disorders |
Behavioral: Cognitive-Behavioral Therapy for Insomnia Drug: zolpidem tartrate (Ambien) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Combined Behavioral/Pharmacological Therapy for Insomnia |
| Estimated Enrollment: | 144 |
| Study Start Date: | September 2001 |
| Estimated Study Completion Date: | 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 to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Chronic primary insomnia which includes at least 6 months of trouble falling asleep or staying asleep
Contacts and Locations| United States, North Carolina | |
| Duke Sleep Disorders Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: William K Wohlgemuth, Ph.D. wkw@geri.duke.edu | |
| Contact: Victoria Herring 919-681-8392 | |
| Principal Investigator: William K Wohlgemuth, Ph.D. | |
| Sub-Investigator: Andrew Krystal, M.D. | |
| Sub-Investigator: Jack D Edinger, Ph.D. | |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00044629 History of Changes |
| Other Study ID Numbers: | R01 MH62119, DSIR 83-ATAS |
| Study First Received: | September 3, 2002 |
| Last Updated: | October 5, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
Sleep Deprivation Insomnia Sleep Disorders |
Additional relevant MeSH terms:
|
Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Mental Disorders Zolpidem Hypnotics and Sedatives Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses GABA-A Receptor Agonists GABA Agonists GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013