Combined Behavioral/Pharmacological Therapy for Insomnia

Duke University

Status and phase: Completed; Phase 2

Conditions: Sleep Initiation and Maintenance Disorders

Treatments: Drug: Placebo; Behavioral: Cognitive-Behavioral Therapy for Insomnia; Drug: zolpidem tartrate (Ambien)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00044629

DSIR 83-ATAS

R01MH062119 (U.S. NIH Grant/Contract)

Pro00011850

Details and patient eligibility

About

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

Full 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.

Enrollment: 162 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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162 participants in 3 patient groups, including a placebo group

Cognitive Behavioral Therapy and Ambien

Experimental group

Description:

Cognitive Behavioral Therapy and Ambien

Treatment:

Drug: zolpidem tartrate (Ambien)

Behavioral: Cognitive-Behavioral Therapy for Insomnia

Cognitive Behavioral Therapy and Placebo

Placebo Comparator group

Description:

Cognitive Behavioral Therapy and Placebo

Treatment:

Drug: Placebo

Behavioral: Cognitive-Behavioral Therapy for Insomnia

Cognitive Behavioral Therapy alone (no drug)

Active Comparator group

Description:

Cognitive Behavioral Therapy alone (no drug)

Treatment:

Behavioral: Cognitive-Behavioral Therapy for Insomnia