CBT-I or Zolpidem/Trazodone for Insomnia

NCT04468776 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: CER-2018C2-13262
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 7

Brief 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

Keywords

Insomnia; Chronic Insomnia; Zolpidem; Ambien; Cognitive-behavioral therapy for insomnia; CBT-I; Rural; Primary Care; Pragmatic Clinical Trial; Comparative Effectiveness; Trazodone

Outcome Measures

Primary Outcomes (1)

• Change in Insomnia Symptom Severity

  Change in Insomnia Severity Index score from baseline to follow-up. The Insomnia Severity Index is a 7-item self-report questionnaire that measures severity of insomnia symptoms during the last two weeks. Each item is scored 0 (no problem) to 4 (very severe problem) and total between 0-28, with higher scores indicating more severe insomnia symptoms. Change is estimated mean change from mixed-effects linear regression model. Fixed effects: Baseline ISI, Treatment Arm, Visit and Treatment Arm\*Visit interaction. Random effects: intercept for Subject, nested within Site.

  Baseline, 6 months

Secondary Outcomes (2)

• Number of Participants With Treatment Response of Insomnia Symptoms

  Baseline, 6 months

• Number of Participants With Remission of Insomnia Symptoms

  6 months

Other Outcomes (12)

• Change in Anxiety and Depression

  Baseline, 6 months

• Change in Cognitive Function

  Baseline, 6 months

• Change in Patient-Reported Health

  Baseline, 6 months

Study Arms (3)

Medication (zolpidem or trazodone)

ACTIVE COMPARATOR

Zolpidem or trazodone, as prescribed by physician

Drug: Zolpidem; Drug: Trazodone

Internet Cognitive Behavioral Therapy for Insomnia (CBT-I)

ACTIVE COMPARATOR

Internet-based CBT-I program

Behavioral: Internet Cognitive Behavioral Therapy for Insomnia (CBT-I)

Combination

EXPERIMENTAL

Medication (zolpidem or trazodone) as prescribed by physician and Internet-based CBT-I program

Drug: Zolpidem; Behavioral: Internet Cognitive Behavioral Therapy for Insomnia (CBT-I); Drug: Trazodone

Interventions

Zolpidem DRUG

Zolpidem, as prescribed by physician

Also known as: Ambien

Combination; Medication (zolpidem or trazodone)

Internet Cognitive Behavioral Therapy for Insomnia (CBT-I) BEHAVIORAL

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

Also known as: SHUTi

Combination; Internet Cognitive Behavioral Therapy for Insomnia (CBT-I)

Trazodone DRUG

Trazodone, as prescribed by physician

Also known as: Desyrel

Combination; Medication (zolpidem or trazodone)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80
• Insomnia Severity Index score \> 10
• Regular internet and computer access
• Receives primary care in a Non-metropolitan/Rural residence

You may not qualify if:

• Use of hypnotic medication \>2 times in the past week
• Current cognitive or cognitive behavioral treatment for insomnia
• Psychotic disorder
• Bipolar disorder
• Current substance use disorder
• Severe Chronic obstructive pulmonary disease (COPD) or other severe pulmonary disease (such as asthma or lung fibrosis)
• Cognitive impairment or dementia
• History of spontaneous or hypnotic-induced complex sleep behavior
• Delayed sleep phase disorder (DSPD)
• Shift work that includes working the night shift (between the hours of 12:00 a.m. - 6:00 a.m.)
• History of fracture or injurious fall in the past 12 months
• Currently pregnant, planning to become pregnant, or breastfeeding
• Other severe or uncontrolled mental or physical disorders that would make participation difficult or unsafe

Sponsors & Collaborators

• California Pacific Medical Center Research Institute: lead
• Patient-Centered Outcomes Research Institute: collaborator
• University of Pittsburgh: collaborator
• University of Arizona: collaborator
• University of Virginia: collaborator
• University of Illinois at Chicago: collaborator

Study Sites (7)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

University of Arizona

Tucson, Arizona, 85721, United States

Location

University of Missouri

Columbia, Missouri, 65212, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Zolpidem; Trazodone

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Pyridones

Results Point of Contact

• Title: Dr. Katie Stone
• Organization: CPMCRI

katie.Stone@ucsf.edu

(510) 427-4562

Study Officials

• Katie L. Stone, PhD

  California Pacific Medical Center/Sutter Bay Hospitals

  PRINCIPAL INVESTIGATOR

• Daniel J. Buysse, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking of participants and providers is not possible given two very different treatment types. The Prime Principal Investigator and a statistician at the Data Coordinating Center will be masked to individual treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a randomized (1:1:1) comparative effectiveness trial of medication preference (zolpidem or trazodone), CBT-I, and the combination for the treatment of insomnia in 155 men and women aged 18-80 years living in rural areas.

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 13, 2020
• Study Start: February 25, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: February 24, 2025
• Results First Posted: February 24, 2025

Record last verified: 2025-02

Locations

US (7)