Stepped Care for Posttraumatic Stress Disorder Study (STEPPS)

Boston Medical Center (BMC)

Status: Not yet enrolling

Conditions: Post Traumatic Stress Disorder

Treatments: Behavioral: WebSTAIR plus coaching; Behavioral: Clinician administered WET; Behavioral: webSTAIR; Behavioral: Clinician administered Brief STAIR

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06947538

H-45694

1R01MH138549-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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

Enrollment: 428 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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428 participants in 4 patient groups

webSTAIR, webSTAIR to WET

Active Comparator group

Description:

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.

Treatment:

Behavioral: webSTAIR

Behavioral: Clinician administered WET

webSTAIR+coaching, webSTAIR+coaching to WET

Active Comparator group

Description:

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.

Treatment:

Behavioral: Clinician administered WET

Behavioral: WebSTAIR plus coaching

webSTAIR, webSTAIR to Brief STAIR

Active Comparator group

Description:

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

Treatment:

Behavioral: Clinician administered Brief STAIR

Behavioral: webSTAIR

webSTAIR+coaching, websTAIR+coaching to Brief STAIR

Active Comparator group

Description:

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.

Treatment:

Behavioral: Clinician administered Brief STAIR

Behavioral: WebSTAIR plus coaching