Stepped Care for Posttraumatic Stress Disorder Study

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Medical Center
Study ID
NCT06947538
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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 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.
  • 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.
  • 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.

Study Details

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).

Key Dates

Start date
Mar 12, 2026
Status verified
Mar 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
428 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: webSTAIR, webSTAIR to WET
    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.
  • Active Comparator: webSTAIR+coaching, webSTAIR+coaching to WET
    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.
  • Active Comparator: webSTAIR, webSTAIR to Brief STAIR
    First, offer skills-focused DMHI; then add clinician-administered skills-focused behavioral treatment for nonresponders and continue skills-focused DMHI for responders.
  • Active Comparator: webSTAIR+coaching, websTAIR+coaching to Brief STAIR
    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.

Primary Outcome Measure

PTSD symptom severity [ Time Frame: baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Medical CenterBostonMassachusetts02118
Sarah Valentine, PhD
[email protected]
857-264-1102

Find similar trials in Boston, MA

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
Boston Medical Center· Boston, MA

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