NOT_YET_RECRUITING

Stepped Care for Posttraumatic Stress Disorder Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Adaptive Interventions to Improve Posttraumatic Stress Disorder (PTSD) Treatment Access, Engagement, and Effectiveness in Routine Care

Quick Facts

Study Start:2026-02
Study Completion:2029-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:NOT_YET_RECRUITING

Study ID

NCT06947538

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Boston Medical Center primary care patient
  2. * At least 18 years of age
  3. * Access to computer or mobile device
  4. * Able to receive treatments in English or Spanish
  5. * Able to read at 4th grade level
  6. * Endorsement of Criterion A trauma using the Life Events Checklist for the DSM-5 (LEC-5), assessed at baseline
  7. * PTSD diagnosis, confirmed by the Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5) assessed at baseline
  8. * Clinically appropriate for outpatient level of care
  9. * Stable on psychotropic medication for \>4 weeks
  1. * Patient is not clinically appropriate for outpatient level of care.
  2. * Acute risk for suicidal thoughts or behaviors, assessed by the Columbia Suicide Severity Rating Scale, administered by research clinician at baseline.

Contacts and Locations

Study Contact

Sarah Valentine, PhD
CONTACT
857 264 1102
sarah.valentine@bmc.org

Principal Investigator

Sarah Valentine, PhD
PRINCIPAL_INVESTIGATOR
Boston Medical Center, Psychiatry

Study Locations (Sites)

Boston Medical Center
Boston, Massachusetts, 02118
United States

Collaborators and Investigators

Sponsor: Boston Medical Center

  • Sarah Valentine, PhD, PRINCIPAL_INVESTIGATOR, Boston Medical Center, Psychiatry

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2026-02
Study Completion Date2029-06

Study Record Updates

Study Start Date2026-02
Study Completion Date2029-06

Terms related to this study

Keywords Provided by Researchers

  • Stepped Care
  • Skills training in affective and interpersonal regulation (STAIR)
  • Digital Mental Health Intervention
  • Written Exposure Therapy (WET)
  • Adaptive Interventions

Additional Relevant MeSH Terms

  • Post Traumatic Stress Disorder