CBT-I or Zolpidem/Trazodone for Insomnia

Summary

This study is a randomized (1:1:1) comparative effectiveness trial of medication (zolpidem or trazodone), cognitive-behavioral therapy for insomnia (CBT-I), and the combination (medication + CBT-I) for the treatment of chronic insomnia in men and women aged 18-80 living in rural areas with 1 year of follow-up. A total of 155 participants will be enrolled and randomized in the United States. This trial is funded by the Patient-Centered Outcomes Research Institute.

Conditions

• Chronic Insomnia

Interventions

DRUG

Zolpidem

Zolpidem, as prescribed by physician

BEHAVIORAL

Internet Cognitive Behavioral Therapy for Insomnia (CBT-I)

6-week internet CBT-I multi-component intervention (SHUTi) including sleep restriction, stimulus control, cognitive restructuring, sleep behaviors, and relapse prevention

DRUG

Trazodone

Trazodone, as prescribed by physician

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• University of Pittsburgh

  collaborator OTHER

• University of Arizona

  collaborator OTHER

• University of Virginia

  collaborator OTHER

• University of Illinois at Chicago

  collaborator OTHER

• California Pacific Medical Center Research Institute

  lead OTHER

Principal Investigators

• Katie L. Stone, PhD · California Pacific Medical Center/Sutter Bay Hospitals

• Daniel J. Buysse, MD · University of Pittsburgh

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-02-25

Primary Completion

2024-06-30

Completion

2024-06-30

FDA Drug

Yes

Countries

• United States

Study Locations