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Stepped Care for Posttraumatic Stress Disorder Study
NCT06947538 · Boston Medical Center
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Adaptive Interventions to Improve Posttraumatic Stress Disorder (PTSD) Treatment Access, Engagement, and Effectiveness in Routine Care
About this study
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 weeks are randomized to either continue webSTAIR or webSTAIR plus community health worker coaching ("stage 1 treatments").
Nonresponders at 8 weeks are re-randomized to clinician-administered treatments, either Brief STAIR or WET ("stage 2 treatments").
Nonresponse is defined as less than a 15-point decrease in PTSD symptom severity, as measured by the PTSD Checklist for DSM-5 (PCL-5).
The objectives of this study are to:
* examine the main effects of stage 1 treatments, stage 2 treatments, and embedded
* adaptive interventions on PTSD symptom severity.
* confirm mechanisms of change established in the extant PTSD literature
* identify patient-level moderators of change in PTSD symptoms severity at 18 weeks
Eligibility 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.
Study design
Enrollment target: 428 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-03-12
Estimated completion: 2029-06
Last updated: 2026-03-13
Interventions
Behavioral: webSTAIRBehavioral: WebSTAIR plus coachingBehavioral: Clinician administered Brief STAIRBehavioral: Clinician administered WET
Primary outcomes
- • PTSD symptom severity (baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks)
- • Treatment retention (4 weeks, 8 weeks, 18 weeks)
- • Treatment acceptability (4 weeks, 8 weeks, 18 weeks, 30 weeks)
Sponsor
Boston Medical Center · other
With: National Institute of Mental Health (NIMH)
Contacts & investigators
ContactSarah Valentine, PhD · contact · sarah.valentine@bmc.org · 857 264 1102
InvestigatorSarah Valentine, PhD · principal_investigator, Boston Medical Center, Psychiatry
All locations (1)
Boston Medical CenterRecruiting
Boston, Massachusetts, United States