Combined Behavioral/Pharmacological Therapy for Insomnia

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ClinicalTrials.gov Identifier: NCT00044629

Recruitment Status : Completed

First Posted : September 5, 2002

Last Update Posted : September 16, 2013

Sponsor:

Collaborator:

National Institute of Mental Health (NIMH)

Information provided by (Responsible Party):

Duke University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Sleep Initiation and Maintenance Disorders	Behavioral: Cognitive-Behavioral Therapy for Insomnia Drug: zolpidem tartrate (Ambien) Drug: Placebo	Phase 2

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 Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	162 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Treatment
Official Title:	Combined Behavioral/Pharmacological Therapy for Insomnia
Study Start Date :	September 2001
Study Completion Date :	August 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Zolpidem Zolpidem tartrate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cognitive Behavioral Therapy and Ambien Cognitive Behavioral Therapy and Ambien	Behavioral: Cognitive-Behavioral Therapy for Insomnia Drug: zolpidem tartrate (Ambien)
Placebo Comparator: Cognitive Behavioral Therapy and Placebo Cognitive Behavioral Therapy and Placebo	Behavioral: Cognitive-Behavioral Therapy for Insomnia Drug: Placebo
Active Comparator: Cognitive Behavioral Therapy alone (no drug) Cognitive Behavioral Therapy alone (no drug)	Behavioral: Cognitive-Behavioral Therapy for Insomnia

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	21 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00044629

Locations


United States, North Carolina
Duke Sleep Disorders Center
Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Duke University

National Institute of Mental Health (NIMH)

More Information


Responsible Party:	Duke University
ClinicalTrials.gov Identifier:	NCT00044629 History of Changes
Other Study ID Numbers:	Pro00011850 R01MH062119 ( U.S. NIH Grant/Contract ) DSIR 83-ATAS
First Posted:	September 5, 2002 Key Record Dates
Last Update Posted:	September 16, 2013
Last Verified:	September 2013

Keywords provided by Duke University:


Sleep Deprivation Insomnia Sleep Disorders

Additional relevant MeSH terms:


Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases Mental Disorders Zolpidem Hypnotics and Sedatives	Central Nervous System Depressants Physiological Effects of Drugs GABA-A Receptor Agonists GABA Agonists GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action

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