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| Comparative effectiveness PTSD trial of sequenced pharmacotherapy and psychotherapy in primary care | |
|---|---|
| Investigator (PI): | Fortney, John |
| Performing Organization (PO): |
(Current): University of Washington, School of Medicine, Department of Psychiatry and Behavioral Sciences / (206) 543-3750 |
| Supporting Agency (SA): | Patient-Centered Outcomes Research Institute (PCORI) |
| Initial Year: | 2020 |
| Final Year: | 2025 |
| Record Source/Award ID: | PCORI/ PTSD-2019C1-15636 |
| Funding: | Total Award Amount: $6,824,666 |
| Award Type: | Contract |
| Award Information: | PCORI: More information and project results (when completed) |
| Abstract: | 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, we 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 Veterans Affairs (VA) medical centers, where the prevalence of both past trauma exposure and PTSD are particularly high. We will enroll 1,500 primary care patients. We 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 assess outcomes important to patients, like self-reported symptom burden, side effects, health-related quality of life, and recovery outcomes, at baseline, 3, and 6 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. |
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| Country: | United States |
| State: | Washington |
| Zip Code: | 98195 |
| UI: | 20211345 |
| CTgovId: | NCT04597190 |
| Project Status: | Ongoing |