Stepped Care for Posttraumatic Stress Disorder Study

NCT06947538 | Recruiting DMC

• 2 other identifiers: H-456941R01MH138549-01
• Study Type: interventional
• Target: 428
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Post Traumatic Stress Disorder

Keywords

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

Outcome Measures

Primary Outcomes (3)

• PTSD symptom severity

  This outcome will be assessed by the PTSD Checklist for the DSM-5 (PCL-5), a 20-item self-report measure that evaluates the degree to which individuals have been bothered by PTSD symptoms in the past month tied to their most distressing event. Total scores ranging from 0 to 80, and a score of 31-33 or higher suggests probable PTSD and potential benefit from treatment.

  baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks

• Treatment retention

  as the proportion (%) of participant who complete 60% of interventions in the treatment windows.

  4 weeks, 8 weeks, 18 weeks

• Treatment acceptability

  This outcome will be assessed with the Client Satisfaction Questionnaire 8 \[CSQ-8\], a 8-item instruction where scores are summed across items once. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.

  4 weeks, 8 weeks, 18 weeks, 30 weeks

Secondary Outcomes (6)

• Trauma coping

  baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks

• Treatment expectancy

  baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks

• Mental health stigma

  baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks

• Medical mistrust

  baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks

• Posttraumatic cognitions

  baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks

Study Arms (4)

webSTAIR, webSTAIR to WET

ACTIVE COMPARATOR

First, offer skills-focused digital mental health intervention (DMHI); then switch to clinician-administered trauma-focused behavioral treatment for nonresponders and continue skills-focused DMHI for responders.

Behavioral: webSTAIR; Behavioral: Clinician administered WET

webSTAIR+coaching, webSTAIR+coaching to WET

ACTIVE COMPARATOR

First, offer skills-focused DMHI plus community health worker (CHW) coaching; then add clinician-administered trauma-focused behavioral treatment for nonresponders and continue skills-focused DMHI plus CHW coaching for responders.

Behavioral: WebSTAIR plus coaching; Behavioral: Clinician administered WET

webSTAIR, webSTAIR to Brief STAIR

ACTIVE COMPARATOR

First, offer skills-focused DMHI; then add clinician-administered skills-focused behavioral treatment for nonresponders and continue skills-focused DMHI for responders.

Behavioral: webSTAIR; Behavioral: Clinician administered Brief STAIR

webSTAIR+coaching, websTAIR+coaching to Brief STAIR

ACTIVE COMPARATOR

First, offer skills-focused DMHI plus CHW coaching; then add clinician-administered skills-focused behavioral treatment for nonresponders and continue skills-focused DMHI plus CHW coaching for responders.

Behavioral: WebSTAIR plus coaching; Behavioral: Clinician administered Brief STAIR

Interventions

Clinician administered Brief STAIR BEHAVIORAL

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.

webSTAIR+coaching, websTAIR+coaching to Brief STAIR; webSTAIR, webSTAIR to Brief STAIR

webSTAIR BEHAVIORAL

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.

webSTAIR, webSTAIR to Brief STAIR; webSTAIR, webSTAIR to WET

WebSTAIR plus coaching BEHAVIORAL

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.

webSTAIR+coaching, webSTAIR+coaching to WET; webSTAIR+coaching, websTAIR+coaching to Brief STAIR

Clinician administered WET BEHAVIORAL

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.

webSTAIR+coaching, webSTAIR+coaching to WET; webSTAIR, webSTAIR to WET

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Medical Center: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Sarah Valentine, PhD

  Boston Medical Center, Psychiatry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Valentine, PhD

CONTACT

857 264 1102; sarah.valentine@bmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study uses a Sequential, Multiple Assignment, Randomized Trial (SMART) design. All participants enrolled will receive access to webSTAIR at baseline ("initial treatment").

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: April 27, 2025
• Study Start: March 12, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)