Combined Behavioral/Pharmacological Therapy for Insomnia
|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|
|Estimated 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|
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|