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Combined Behavioral/Pharmacological Therapy for Insomnia

NCT ID: NCT00044629

Last Updated: 2013-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2006-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Sleep Initiation and Maintenance Disorders

Keywords

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Sleep Deprivation Insomnia Sleep Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Cognitive Behavioral Therapy and Ambien

Cognitive Behavioral Therapy and Ambien

Group Type EXPERIMENTAL

Cognitive-Behavioral Therapy for Insomnia

Intervention Type BEHAVIORAL

zolpidem tartrate (Ambien)

Intervention Type DRUG

Cognitive Behavioral Therapy and Placebo

Cognitive Behavioral Therapy and Placebo

Group Type PLACEBO_COMPARATOR

Cognitive-Behavioral Therapy for Insomnia

Intervention Type BEHAVIORAL

Placebo

Intervention Type DRUG

Cognitive Behavioral Therapy alone (no drug)

Cognitive Behavioral Therapy alone (no drug)

Group Type ACTIVE_COMPARATOR

Cognitive-Behavioral Therapy for Insomnia

Intervention Type BEHAVIORAL

Interventions

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Cognitive-Behavioral Therapy for Insomnia

Intervention Type BEHAVIORAL

zolpidem tartrate (Ambien)

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Duke Sleep Disorders Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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R01MH062119

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DSIR 83-ATAS

Identifier Type: -

Identifier Source: secondary_id

Pro00011850

Identifier Type: -

Identifier Source: org_study_id