Stepped Care for Posttraumatic Stress Disorder Study

Purpose

Posttraumatic stress disorder (PTSD) prevalence can be as high as 50% in low income and racially diverse primary care clinics, wherein only 13% of people with PTSD receive any treatment. This study extends a program of research by the investigator focused on developing adaptive 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, less burdensome to systems of care, and highly acceptable to diverse patients and care settings. These treatments are: web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR), Brief STAIR, and Written Exposure Therapy (WET).

Condition

  • Post Traumatic Stress Disorder

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 - 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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
This study uses a Sequential, Multiple Assignment, Randomized Trial (SMART) design. All participants enrolled will receive access to webSTAIR at baseline ("initial treatment").
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • 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: 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.
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.
  • 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 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.
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.
  • 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: 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.
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.
  • 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.

Recruiting Locations

Boston Medical Center
Boston, Massachusetts 02118
Contact:
Sarah Valentine, PhD
857-264-1102
sarah.valentine@bmc.org

More Details

Status
Recruiting
Sponsor
Boston Medical Center

Study Contact

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

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