Stepped care approach for PTSD
Official title: Adaptive Interventions to Improve Posttraumatic Stress Disorder (PTSD) Treatment Access, Engagement, and Effectiveness in Routine Care
Run by Boston Medical Center · NCT06947538 · Data updated 2026-11-12
This program tests a stepped care pathway that starts everyone on a web-based skills program and adds coaching or brief clinician treatments as needed for adults with PTSD.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 428 (estimated) |
| Sponsor | Boston Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | March 12, 2026 |
| Main results expected | June 2029 |
| Study ends | June 2029 |
| Registry record updated | July 14, 2026 |
| Trial ID | NCT06947538 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are Boston Medical Center primary care patients aged 18 or older with a CAPS-5-confirmed PTSD diagnosis who are appropriate for outpatient care, can read English or Spanish, have access to a computer or mobile device, and are stable on psychotropic medication.
✕Probably not a fit
People already engaged in clinician-administered therapy, those who need higher-than-outpatient care, or those with acute suicide risk are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This SMART-design trial gives all participants web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR) at baseline and adapts treatment based on early response. Nonresponders at 4 weeks are randomized to continue webSTAIR alone or webSTAIR plus community health worker coaching, and nonresponders at 8 weeks are re-randomized to clinician-delivered Brief STAIR or Written Exposure Therapy (WET). Nonresponse is defined as less than a 15-point decrease on the PCL-5, and PTSD symptom severity and related outcomes are measured through 18 weeks. The trial tests main effects of stage 1 and stage 2 options, examines mechanisms of change, and looks for patient-level moderators to inform which sequences work best.
Why it matters
Potential benefit: If successful, this approach could expand access to effective PTSD care by starting with a low-burden web program and reserving brief clinician input for people who need it.
How similar studies have gone: Components like STAIR and WET have demonstrated efficacy in prior trials and digital PTSD interventions show promising but variable results, so the stepped sequencing builds on established treatments though the full adaptive pathway is less tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: Assessed at pre-screening * Boston Medical Center primary care patient * At least 18 years of age * Access to computer or mobile device * Able to receive treatments in English or Spanish * Able to read at 4th grade level Assessed at baseline * Endorsement of Criterion A trauma using the Life Events Checklist for the DSM-5 (LEC-5), assessed at baseline * PTSD diagnosis, confirmed by the Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5) assessed at baseline \- Concordance between CAPS-5 and PCL-5 at baseline * Clinically appropriate for outpatient level of care * Stable on psychotropic medication for \>4 weeks Exclusion criteria: Assessed at pre-screening • Patient is currently engaged in clinician-administered therapy Assessed at baseline (clinician interview) * Patient is not clinically appropriate for outpatient level of care. * Acute risk for suicidal thoughts or behaviors, assessed by the Columbia Suicide Severity Rating Scale, administered by research clinician at baseline.
Where it's running
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Boston Medical Center
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Sarah Valentine, PhD — Boston Medical Center, Psychiatry
- Study coordinator: Sarah Valentine, PhD
- Email: sarah.valentine@bmc.org
- Phone: 857 264 1102
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.