Combined Behavioral/Pharmacological Therapy for Insomnia
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|ClinicalTrials.gov Identifier: NCT00044629|
Recruitment Status : Completed
First Posted : September 5, 2002
Last Update Posted : September 16, 2013
|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|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||162 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Combined Behavioral/Pharmacological Therapy for Insomnia|
|Study Start Date :||September 2001|
|Study Completion Date :||August 2006|
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|
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
|United States, North Carolina|
|Duke Sleep Disorders Center|
|Durham, North Carolina, United States, 27710|