Sequenced Treatment Effectiveness for Posttraumatic Stress
Status:
Recruiting
Trial end date:
2024-01-01
Target enrollment:
Participant gender:
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 1,400 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, 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.
Phase:
Phase 4
Details
Lead Sponsor:
University of Washington
Collaborators:
Boston University Harvard University Patient-Centered Outcomes Research Institute Stanford University Washington State University