Stepped care approach for PTSD
Adaptive Interventions to Improve Posttraumatic Stress Disorder (PTSD) Treatment Access, Engagement, and Effectiveness in Routine Care
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 428 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boston Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06947538 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 * 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 this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.