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Completed Phase 4 Interventional Results available

Sequenced Treatment Effectiveness for Posttraumatic Stress

ClinicalTrials.gov ID: NCT04597190

Public ClinicalTrials.gov record NCT04597190. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 4, 2026, 7:28 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Comparative Effectiveness PTSD Trial of Sequenced Pharmacotherapy and Psychotherapy in Primary Care

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Individuals with PTSD are more likely to engage in unhealthy behaviors such as tobacco use, drug use, alcohol misuse, and have high rates of morbidity/mortality. PTSD negatively impacts marriages, educational attainment, and occupational functioning. Some patients with PTSD can be successfully referred to specialty mental health clinics, but most patients with PTSD cannot engage in specialty care because of geographical, financial and cultural barriers and must be treated in primary care. However, policy makers do not know the best way to treat PTSD in primary care clinics, especially for patients who do not respond to the initial treatment choice. There are effective treatments for PTSD that are feasible to deliver in primary care. These treatments include commonly prescribed antidepressants and brief exposure-based therapies. However, because there are no head-to-head comparisons between pharmacotherapy and psychotherapy in primary care settings, primary care providers do not know which treatments to recommend to their patients. In addition, despite high treatment non-response rates, very few studies have examined which treatment should be recommend next when patients do not respond well to the first, and no such studies have been conducted in primary care settings. This trial will be conducted in Federally Qualified Health Centers and VA Medical Centers, where the prevalence of both past trauma exposure and PTSD are particularly high. The investigators will enroll 700 primary care patients. The investigators propose to 1) compare outcomes among patients randomized to initially receive pharmacotherapy or brief psychotherapy, 2) compare outcomes among patients randomized to treatment sequences (i.e., switching and augmenting) for patients not responding to the initial treatment and 3) examine variation in treatment outcomes among different subgroups of patients. Telephone and web surveys will be used to assessed outcomes important to patients, like self-reported symptom burden, side-effects, health related quality of life, and recovery outcomes, at baseline, 4 and 8 months. Results will help patients and primary care providers choose which treatment to try first and which treatment to try second if the first is not effective.

Study identification

NCT ID
NCT04597190
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
University of Washington
Other
Enrollment
700 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 31, 2020
Primary completion
Jul 31, 2024
Completion
Jul 31, 2024
Last update posted
May 7, 2025

2020 – 2024

United States locations

U.S. sites
15
U.S. states
11
U.S. cities
14
Facility City State ZIP Site status
Little Rock VA Medical Center North Little Rock Arkansas 72214
East Arkansas Family Health Center West Memphis Arkansas 72301
Neighborhood Healthcare San Diego California 92025
San Diego VA Medical Center San Diego California 92161
VA Eastern Colorado Health Care Aurora Colorado 80045
Bedford VA Medical Center Bedford Massachusetts 01730
Ann Arbor VA Medical Center Ann Arbor Michigan 49109
Upper Great Lakes Family Health Center Hancock Michigan 49930
Family Medical Center of Michigan Temperance Michigan 48182
Partnership Health Center Missoula Montana 59802
Cincinnati VA Medical Center Cincinnati Ohio 45220
Portland VA Medical Center Portland Oregon 97239
Ralph H. Johnson VA Medical Center Charleston South Carolina 29401
North Central Texas Community Health Center Wichita Falls Texas 76301
Healthpoint SeaTac Washington 98188

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04597190, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 7, 2025 · Synced Sep 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04597190 live on ClinicalTrials.gov.

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