Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04597190 |
| Other study ID # |
STUDY00011185 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2021 |
| Est. completion date |
December 31, 2025 |
Study information
| Verified date |
May 2024 |
| Source |
University of Washington |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 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.
Description:
Background: In primary care settings, PTSD frequently goes undetected and untreated. When
PTSD is diagnosed in primary care, treatment is usually inadequate and outcomes are poor.
This is highly problematic because many patients with PTSD prefer receiving care in primary
care settings, and less than half are successfully referred to the specialty mental health
setting. This is especially a concern for safety net primary settings such as Federally
Qualified Health Centers and VA Medical Centers, where the prevalence of both past trauma
exposure and PTSD are particularly high. However, there are effective pharmacotherapy and
psychotherapy treatments for PTSD that are feasible to deliver in primary care.
Objective: Because there are no head-to-head comparisons of pharmacotherapy and psychotherapy
for PTSD among 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.
Methods: This multi-site trial will enroll 700 patients meeting clinical criteria for PTSD
from 7 Federally Qualified Health Centers and 8 VA Medical Centers. The pharmacotherapy
treatments are sertraline, fluoxetine, paroxetine and venlafaxine. The psychotherapy
treatment is Written Exposure Therapy. Telephone and web surveys will be used to assessed
outcomes (patient treatment engagement, self-reported symptom burden, health related quality
of life, and recovery outcomes) at baseline, 4 and 8 months. Patients will be the unit of the
intent-to-treat analysis. Multiple imputation will be used for missing data. Mixed-models
will be used to test hypotheses.
Significance: Due to a lack of head-to-head comparisons between pharmacotherapy and
psychotherapy protocols, clinical practice guidelines for PTSD provide contradictory
recommendations about pharmacotherapy and psychotherapy. In particular, PTSD clinical
practice guidelines have little to offer primary care providers because so few trials have
been conducted in this setting. The proposed large pragmatic trial will compare,
head-to-head, FDA approved PTSD medications with a brief trauma-focused psychotherapy that is
evidence-based and feasible to deliver in primary care. In addition, despite high treatment
non-response rates, very few trials have examined treatment sequencing and none have done so
in the primary care setting. For patients not responding to the initial treatment, the
proposed research is powered to compare, head-to-head, alternative treatment sequences that
are feasible to deliver in primary care.
