Antidepressants + Therapy for PTSD
(STEPS Trial)

Recruiting in Palo Alto (17 mi)

+15 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of Washington

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults with PTSD who have experienced trauma, as indicated by specific screening tests. It's not for those under 18, recently changed psychotropic meds, prefer specialty mental health care, prisoners, non-English/Spanish speakers, terminally ill or decision-impaired individuals. Also excluded are those on venlafaxine or diagnosed with schizophrenia, schizoaffective disorder, bipolar disorder or dementia.

Inclusion Criteria

You have PTSD symptoms as indicated by a positive result on two screening tests called PC-PTSD and PCL.

You have experienced a traumatic event and have symptoms related to it.

Exclusion Criteria

I have a mental health appointment scheduled or prefer specialized mental health care.

I haven't changed my mental health medication in the last 2 months.

I cannot communicate in English or Spanish.

+7 more

Participant Groups

The study compares initial treatments of PTSD in primary care settings: antidepressants versus brief psychotherapy. For non-responders to the first treatment choice, it will test different follow-up strategies (switching or augmenting). The goal is to determine which sequence of treatments works best.

3Treatment groups

Active Control

Group I: SSRI Then Augmentation by WETActive Control2 Interventions

Prescribers will prescribe one of three SSRIs (sertraline, fluoxetine or paroxetine). Patients who do not respond to treatment by four months will have their treatment augmented by Written Exposure Therapy (WET) delivered by an integrated behavioral health consultant.

Group II: SSRI Then Switch to SNRIActive Control2 Interventions

Prescribers will prescribe one of three SSRIs (sertraline, fluoxetine or paroxetine). Patients who do not respond to treatment by four months will have their treatment switched to the SNRI (serotonin-norepinephrine reuptake Inhibitor) venlafaxine.

Group III: WET Then Switch to SSRIActive Control2 Interventions

Integrated behavioral health consultants will deliver WET. Patients who do not respond to treatment by four months will be switched to one of three SSRIs (sertraline, fluoxetine or paroxetine).