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Stepped Care for Posttraumatic Stress Disorder Study

Stepped Care for Posttraumatic Stress Disorder Study

Recruiting
18 years and older
All
Phase N/A

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Overview

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 intervention sequences a digital mental health intervention (DMHI) and brief trauma- and skills-focused treatments for PTSD. The selected treatments are brief and scalable and less burdensome to systems of care. These treatments are: web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR), Brief STAIR, and Written Exposure Therapy (WET).

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 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

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 details
    Post Traumatic Stress Disorder

NCT06947538

Boston Medical Center

13 May 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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