Sleep Initiation and Maintenance Disorders Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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