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Sequenced Treatment Effectiveness for Posttraumatic Stress
Not Recruiting
Trial ID: NCT04597190
Purpose
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.
Official Title
Comparative Effectiveness PTSD Trial of Sequenced Pharmacotherapy and Psychotherapy in Primary Care
Stanford Investigator(s)
Debra Lee Kaysen
Professor of Psychiatry and Behavioral Sciences (Public Mental Health & Population Sciences)
Eligibility
Inclusion Criteria:
- Screen positive for PTSD (PC-PTSD>=3 AND PCL>=33)
- Screen positive for trauma (Brief Trauma questionnaire)
Exclusion Criteria:
- 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
Intervention(s):
drug: Selective serotonin reuptake inhibitor
drug: Serotonin-norepinephrine reuptake inhibitor
behavioral: Written Exposure Therapy
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305