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NCT04597190 · ClinicalTrials.gov registry record · Phase 4
Sequenced Treatment Effectiveness for Posttraumatic Stress
A Phase 4 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 4
- Development phase
- 700
- Enrollment target
NCT04597190: Completed Phase 4 study, sponsored by University of Washington.
NCT04597190 is a Phase 4 study that has completed, run by University of Washington. The registered enrollment target is 700 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04597190, a Phase 4 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 700 participants
- Enrollment target
Study Summary
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 s
Primary Outcome
Self reported burden of PTSD symptoms (PCL-5) (range 0-80, higher scores are worse)
Interventions
- BEHAVIORAL Written Exposure Therapy
- DRUG Selective serotonin reuptake inhibitor
- DRUG Serotonin-norepinephrine reuptake inhibitor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 700 participants |
| Start Date | 2020-06-01 |
| Est. Completion | 2024-08-01 |
| Phase | Phase 4 |
What the finished NCT04597190 record still lists
NCT04597190 is an interventional study that assigns participants to a tested intervention. The registered 700 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (35% higher).
The record links to 0 conditions, and to 3 interventions - of which Written Exposure Therapy is the first listed.
NCT04597190 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04597190 about?
NCT04597190 is a clinical study titled "Sequenced Treatment Effectiveness for Posttraumatic Stress". 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 refer...
What is the current status of trial NCT04597190?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 700 participants. The study started on 2020-06-01. Estimated completion is 2024-08-01.
What interventions are being tested in trial NCT04597190?
The interventions under investigation include: Written Exposure Therapy (BEHAVIORAL), Selective serotonin reuptake inhibitor (DRUG), Serotonin-norepinephrine reuptake inhibitor (DRUG).
Who is sponsoring clinical trial NCT04597190?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04597190's enrollment target sits among peer trials
700 114th of 2000 higher than 1,882 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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