Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia Phenotypes Based on Objective Sleep Duration: A Sequential Cohort/Randomized Controlled Trial

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Behavioral, Drug, Other
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

Individuals who have insomnia with short sleep duration (ISS) differ from individuals who have insomnia with normal sleep duration (INS) in terms of health risks (i.e., hypertension) and treatment response. This study will examine whether patients with ISS and INS demonstrate a differential response to two common insomnia treatments. One is behavioral, Cognitive Behavioral Therapy for Insomnia (CBT-I). The other is a widely prescribed, non-habit-forming medication, trazodone used at a low dose. The investigators' findings could lead to evidence-based treatment guidelines that help clinicians more effectively match treatments to insomnia patients and reduce associated health problems.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age 18 or older

• Able to read and effectively communicate in English at the United States sites or able to read and effectively communicate in English or French at the Canadian site.

• Meets criteria for chronic insomnia

• Body Mass Index (BMI) 18.5 kg/m2 and higher

Locations
United States
Colorado
National Jewish Health
RECRUITING
Denver
Pennsylvania
Penn State University
RECRUITING
Hershey
University of Pittsburgh
RECRUITING
Pittsburgh
Other Locations
Canada
Université Laval
RECRUITING
Québec
Contact Information
Primary
Carrie Criley
ccriley@pennstatehealth.psu.edu
717-531-4123
Time Frame
Start Date: 2024-03-20
Estimated Completion Date: 2028-05-31
Participants
Target number of participants: 600
Treatments
Placebo_comparator: Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with placebo
Subjects with insomnia treated with Cognitive Behavior Treatment for Insomnia (CBT-I) for 8 weeks, then non-remitting subjects received placebo for 8 weeks.
Active_comparator: Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with Trazodone
Subjects with insomnia treated with Cognitive Behavior Treatment for Insomnia (CBT-I) for 8 weeks, then non-remitting subjects received trazodone for 8 weeks.
Related Therapeutic Areas
Sponsors
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Leads: Milton S. Hershey Medical Center

This content was sourced from clinicaltrials.gov