Recruiting

webSTAIR, Brief STAIR, WET

Sponsor:

Boston Medical Center

Code:

NCT06947538

Conditions

Post Traumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

webSTAIR

WebSTAIR plus coaching

Clinician administered Brief STAIR

Clinician administered WET

Study Details

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

Study ID

NCT06947538

Start date

Mar 12, 2026

Status verified date

Jul, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Jun, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

\- Concordance between CAPS-5 and PCL-5 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.

Study Design

Enrollment

428 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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 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 for responders.

active comparator: 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 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.

Interventions

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.

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.

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.

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.

Primary outcome measure

  • PTSD symptom severity [ Time Frame: baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks ]
  • Treatment retention [ Time Frame: 4 weeks, 8 weeks, 18 weeks ]
  • Treatment acceptability [ Time Frame: 4 weeks, 8 weeks, 18 weeks, 30 weeks ]

Central Contacts and Locations

Central contacts

Sarah Valentine, PhD

857 264 1102sarah.valentine@bmc.org

Locations

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Sarah Valentine, PhD

857-264-1102sarah.valentine@bmc.org

More Information

Sponsor

Boston Medical Center

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Medical Center on 2026-07-14.