Sequenced Treatment Effectiveness for Posttraumatic Stress
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.
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
- Enrollment
- 700 participants
Conditions and interventions
Conditions
Interventions
- Selective serotonin reuptake inhibitor Drug
- Serotonin-norepinephrine reuptake inhibitor Drug
- Written Exposure Therapy Behavioral
Drug · Behavioral
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.