Combined Behavioral/Pharmacological Therapy for Insomnia

Phase 2

Completed

• Conditions: Sleep Initiation and Maintenance Disorders
• Interventions: Behavioral: Cognitive-Behavioral Therapy for Insomnia; Drug: zolpidem tartrate (Ambien); Drug: Placebo

• Registration Number: NCT00044629
• Lead Sponsor: Duke University

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.

Study Timeline

• Study Start: 2001-09
• Study First Submitted: 2002-09-03
• Study First Submitted QC: 2002-09-04
• Study First Posted: 2002-09-05
• Study Completion: 2006-08
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-12
• Last Update Posted: 2013-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Behavioral Therapy and Ambien	Cognitive-Behavioral Therapy for Insomnia	Cognitive Behavioral Therapy and Ambien
Cognitive Behavioral Therapy and Ambien	zolpidem tartrate (Ambien)	Cognitive Behavioral Therapy and Ambien
Cognitive Behavioral Therapy and Placebo	Cognitive-Behavioral Therapy for Insomnia	Cognitive Behavioral Therapy and Placebo
Cognitive Behavioral Therapy and Placebo	Placebo	Cognitive Behavioral Therapy and Placebo
Cognitive Behavioral Therapy alone (no drug)	Cognitive-Behavioral Therapy for Insomnia	Cognitive Behavioral Therapy alone (no drug)

Trial Locations

Locations (1)

Duke Sleep Disorders Center; 🇺🇸 Durham, North Carolina, United States