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Search / Trial NCT06947538

Stepped Care for Posttraumatic Stress Disorder Study

Launched by BOSTON MEDICAL CENTER · Apr 21, 2025

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Stepped Care Skills Training In Affective And Interpersonal Regulation (Stair) Digital Mental Health Intervention Written Exposure Therapy (Wet) Adaptive Interventions

ClinConnect Summary

The Stepped Care for Posttraumatic Stress Disorder Study is looking to find effective ways to help people with Posttraumatic Stress Disorder (PTSD), especially in primary care settings where many patients from diverse backgrounds may not receive the treatment they need. This study will test a combination of digital mental health tools and brief therapy sessions aimed at improving the emotional and interpersonal skills of participants. The goal is to create a treatment plan that is easy for patients to access and use, allowing them to get help in a way that fits into their lives.

To be eligible for the study, participants need to be at least 18 years old, a patient at Boston Medical Center, and have access to a computer or smartphone. They should also be comfortable receiving treatment in English or Spanish and be able to read at a 4th-grade level. Participants will be screened to confirm they have experienced trauma and have a diagnosis of PTSD. Those who take part can expect to engage in online and brief therapy sessions that are designed to be supportive and helpful. It’s important to note that people currently receiving therapy or those at high risk for suicide will not be included in the study.

Gender

ALL

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.

About Boston Medical Center

Boston Medical Center (BMC) is a leading academic medical center located in Boston, Massachusetts, dedicated to providing high-quality, compassionate care to diverse populations. As a prominent clinical trial sponsor, BMC conducts innovative research aimed at advancing medical knowledge and improving patient outcomes across a wide range of specialties. With a commitment to health equity and access to care, BMC collaborates with various stakeholders, including academic institutions and industry partners, to facilitate groundbreaking studies and translate findings into effective treatments. Its robust infrastructure and experienced research teams ensure adherence to the highest ethical standards and regulatory compliance in all clinical trials.

Locations

Boston, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Sarah Valentine, PhD

Principal Investigator

Boston Medical Center, Psychiatry

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported