Combined Behavioral/Pharmacological Therapy for Insomnia

Study Overview
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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.

Official Title
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Combined Behavioral/Pharmacological Therapy for Insomnia

Conditions
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Sleep Initiation and Maintenance Disorders

Intervention / Treatment
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* Behavioral: Cognitive-Behavioral Therapy for Insomnia
* Drug: zolpidem tartrate (Ambien)
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Behavioral Therapy and Ambien<br>Cognitive Behavioral Therapy and Ambien | Behavioral: Cognitive-Behavioral Therapy for Insomnia<br> <br> Drug: zolpidem tartrate (Ambien)<br> <br> |
| Placebo Comparator: Cognitive Behavioral Therapy and Placebo<br>Cognitive Behavioral Therapy and Placebo | Behavioral: Cognitive-Behavioral Therapy for Insomnia<br> <br> Drug: Placebo<br> <br> |
| Active Comparator: Cognitive Behavioral Therapy alone (no drug)<br>Cognitive Behavioral Therapy alone (no drug) | Behavioral: Cognitive-Behavioral Therapy for Insomnia<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep Deprivation, Insomnia, Sleep Disorders