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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 is a Phase 4 study that has completed, run by University of Washington. The registered enrollment target is 700 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04597190
The ClinicalTrials.gov registry entry for NCT04597190 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 700 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Written Exposure Therapy is the first listed.
NCT04597190 reports 0 study locations.
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.
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