Sequenced Treatment Effectiveness for Posttraumatic Stress
Completed · Phase 4
Conditions studied: PTSD
In brief
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.
Key facts
- Study ID
- NCT04597190
- Run by
- University of Washington
- People needed
- 700
- Starts
- 2020-06-01
- Expected to finish
- 2024-08-01
- Last updated by the study team
- 2025-05-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Screen positive for PTSD (PC-PTSD>=3 AND PCL>=33)
- Screen positive for trauma (Brief Trauma questionnaire)
You may not qualify if…
- Diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder or dementia
- Current prescription of venlafaxine
- Change in any psychotropic prescription in the past 2 months
- A scheduled specialty mental health appointment or preference for specialty mental health care
- Pregnant
- Terminally ill
- Prisoner
- Unable to communicate in English or Spanish
- <18 years of age
- Impaired decision making capacity
Where it is running
- Little Rock VA Medical Center — North Little Rock, Arkansas, United States
- East Arkansas Family Health Center — West Memphis, Arkansas, United States
- Neighborhood Healthcare — San Diego, California, United States
- San Diego VA Medical Center — San Diego, California, United States
- VA Eastern Colorado Health Care — Aurora, Colorado, United States
- Bedford VA Medical Center — Bedford, Massachusetts, United States
- Ann Arbor VA Medical Center — Ann Arbor, Michigan, United States
- Upper Great Lakes Family Health Center — Hancock, Michigan, United States
- Family Medical Center of Michigan — Temperance, Michigan, United States
- Partnership Health Center — Missoula, Montana, United States
- Cincinnati VA Medical Center — Cincinnati, Ohio, United States
- Portland VA Medical Center — Portland, Oregon, United States
- Ralph H. Johnson VA Medical Center — Charleston, South Carolina, United States
- North Central Texas Community Health Center — Wichita Falls, Texas, United States
- Healthpoint — SeaTac, Washington, United States
Full record on ClinicalTrials.gov
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