Combined Behavioral/Pharmacological Therapy for Insomnia

Sleep Initiation and Maintenance Disorders Clinical Trial

Official title:

Combined Behavioral/Pharmacological Therapy for Insomnia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00044629
• Other study ID #: Pro00011850
• Secondary ID: R01MH062119DSIR
• Status: Completed
• Phase: Phase 2
• First received: September 3, 2002
• Last updated: September 12, 2013
• Start date: September 2001
• Est. completion date: August 2006

Study information

• Verified date: September 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study will determine how sleeping pills can be combined with nondrug treatments to maximize the benefits of therapy for insomnia.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Cognitive-Behavioral Therapy for Insomnia

Drug:
• zolpidem tartrate (Ambien)

• Placebo

Locations

Country	Name	City	State
United States	Duke Sleep Disorders Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States,