Status:
NOT_YET_RECRUITING
Stepped Care for Posttraumatic Stress Disorder Study
Lead Sponsor:
Boston Medical Center
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Post Traumatic Stress Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Less than 20% of people with PTSD receive any treatment. This study extends a program of research by the investigator focused on developing adaptive (stepped) interventions for PTSD. The adaptive inte...
Detailed Description
This study uses a Sequential, Multiple Assignment, Randomized Trial (SMART) design. All participants enrolled will receive access to webSTAIR at baseline ("initial treatment"). Nonresponders at 4 wee...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
428 Patients enrolled
Trial Details
Trial ID
NCT06947538
Start Date
February 1 2026
End Date
June 1 2029
Last Update
October 7 2025
Active Locations (1)
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1
Boston Medical Center
Boston, Massachusetts, United States, 02118