Combined Behavioral/Pharmacological Therapy for Insomnia
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Sleep Initiation and Maintenance Disorders
- Sponsor
- Duke University
- Enrollment
- 162
- Locations
- 1
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
This study will determine how sleeping pills can be combined with nondrug treatments to maximize the benefits of therapy for insomnia.
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.
Investigators
Eligibility 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
Arms & Interventions
Cognitive Behavioral Therapy and Placebo
Cognitive Behavioral Therapy and Placebo
Intervention: Placebo
Cognitive Behavioral Therapy alone (no drug)
Cognitive Behavioral Therapy alone (no drug)
Intervention: Cognitive-Behavioral Therapy for Insomnia
Cognitive Behavioral Therapy and Placebo
Cognitive Behavioral Therapy and Placebo
Intervention: Cognitive-Behavioral Therapy for Insomnia
Cognitive Behavioral Therapy and Ambien
Cognitive Behavioral Therapy and Ambien
Intervention: Cognitive-Behavioral Therapy for Insomnia
Cognitive Behavioral Therapy and Ambien
Cognitive Behavioral Therapy and Ambien
Intervention: zolpidem tartrate (Ambien)
Outcomes
Primary Outcomes
Not specified