NCT06947538

Stepped Care for Posttraumatic Stress Disorder Study

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 428 (estimated)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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).

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 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

Conditions

• Post Traumatic Stress Disorder

Interventions

Type	Name	Description
BEHAVIORAL	webSTAIR	WebSTAIR consists of 10 online modules that provide psychoeducation on trauma and emotions and teach skills to improve coping with emotions and strengthen interpersonal relationships. Modules are completed at the participants' own pace and utilize interactive exercises, and audio and video components to aid in delivery.
BEHAVIORAL	WebSTAIR plus coaching	WebSTAIR with up to five 30-min coaching sessions with a CHW will focus on guiding participants through the program, discussing exercises that are valuable or problematic, and reviewing module content.
BEHAVIORAL	Clinician administered Brief STAIR	Brief STAIR is a brief, low intensity, therapy that utilizes psychoeducation, coping skills training, and does not include recounting of the trauma memory, making it highly tolerable. It will be delivered by mental health clinicians in five to six 30-minute individual sessions.
BEHAVIORAL	Clinician administered WET	WET is a brief, high intensity, exposure-based treatment delivered by mental health clinicians consisting of six 30-minute individual sessions that cover treatment rationale, psychoeducation about PTSD, and directing participants to write in session about their traumatic experience using scripted instructions.

Timeline

• Start date: 2026-03-12
• Primary completion: 2029-06-01
• Completion: 2029-06-01
• First posted: 2025-04-27
• Last updated: 2026-03-13

Locations

1 site across 1 country: United States