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Clinical Trials/NCT00044629
NCT00044629
Completed
Phase 2

Combined Behavioral/Pharmacological Therapy for Insomnia

Duke University1 site in 1 country162 target enrollmentSeptember 2001

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.

Registry
clinicaltrials.gov
Start Date
September 2001
End Date
August 2006
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Study Sites (1)

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