Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMilton S. Hershey Medical Center

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Age < 18

Unable 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.

Unwilling to share email address/cell phone number to accept survey links.

Life time diagnosis of psychotic or bipolar disorder

Trial design

Treatments tested in this trial

  • Cognitive Behavioral Treatment for Insomnia (CBT-I)
  • Trazodone
  • Placebo

Treatment groups

600 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Milton S. Hershey Medical Center

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator