Project Summary

PCORI has identified Post-Traumatic Stress Disorder (PTSD) as an important research topic. Patients, caregivers, clinicians, and others want to learn: Which treatments for adults with PTSD are most effective, and for whom? To help answer this question, PCORI launched an initiative in 2019 on Treatment of Post-Traumatic Stress Disorder (PTSD) in Adults. The initiative funded this research project and others.

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Posttraumatic stress disorder, or PTSD, is a mental health problem that can occur after a traumatic event. People with PTSD may have bad dreams or scary thoughts.

Patients often receive treatment for PTSD in mental health clinics. But this type of care can be expensive, and it isn’t always available near where patients live. One option is for patients with PTSD to get treatment in primary care settings. For example, primary care doctors can prescribe medicine. Therapists who share space in a primary care clinic could provide talk therapy. But questions remain about the best ways to treat PTSD in primary care settings, especially for patients who don’t improve after the first treatment.

In this study, the research team is comparing PTSD treatment with antidepressants to written exposure therapy. In written exposure therapy, a therapist helps patients write about a traumatic memory to help lessen their PTSD symptoms. The team is also comparing three treatment sequences:

  • Treatment starts with medicine. Patients who don’t feel better after four months receive written exposure therapy along with the medicine.
  • Treatment starts with medicine. Patients who don’t feel better after four months switch to a different medicine.
  • Treatment starts with written exposure therapy. Patients who don’t feel better after four months switch to medicine.

Who can this research help?

Results may help patients and primary care providers when considering ways to treat PTSD.

What is the research team doing?

The research team is enrolling 1,400 patients with PTSD. All patients are receiving primary care at Veterans Affairs medical centers or other federal health centers across the country. The team is assigning patients by chance to one of three treatment sequences. After four months with the first treatment, if a patient’s symptoms don’t improve, the patient switches to or adds another treatment.

Patients are completing surveys by phone or online when they start the study and again after four and eight months. Surveys ask about patients’ symptoms, quality of life, depression, anxiety, and side effects of medicines. The research team is comparing these outcomes between patients who receive medicine versus written exposure therapy. The team is also comparing these outcomes across the three treatment sequences.

People with PTSD, primary care providers, health center administrators, and policy makers are helping to plan and conduct the study.

Research methods at a glance

Design Element Description
Design Randomized controlled trial
Population 1,400 adults with PTSD receiving primary care at Veterans Affairs medical centers or other federal health centers across the United States
Interventions/
Comparators
  • Treatment with sertraline, paroxetine, or fluoxetine plus written exposure therapy if needed
  • Treatment with sertraline, paroxetine, or fluoxetine, switching to venlafaxine if needed
  • Written exposure therapy and then switching to treatment with sertraline, paroxetine, or fluoxetine if needed
Outcomes

Primary: PTSD symptoms

Secondary: mental health-related quality of life, depression, anxiety, medicine side effects, engagement in treatment, recovery outcomes

Timeframe 8-month follow-up for primary outcome

Project Information

John Fortney, PhD
University of Washington
$6,824,666
Comparative Effectiveness Posttraumatic Stress Disorder Trial of Sequenced Pharmacotherapy and Psychotherapy in Primary Care

Key Dates

November 2019
March 2025
2019

Study Registration Information

Tags

Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: March 14, 2022