Clinical trial NCT06947538: Stepped Care for Posttraumatic Stress Disorder Study
Official title: Adaptive Interventions to Enhance Equitable Access, Engagement, and Effectiveness of Posttraumatic Stress Disorder (PTSD) Treatments in Settings With Low Access to Mental Health Specialty Care
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post Traumatic Stress Disorder
Keywords: Stepped Care
Skills training in affective and interpersonal regulation (STAIR)
Digital Mental Health Intervention
Written Exposure Therapy (WET)
Adaptive Interventions
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2025-04-27
Enrollment: 428
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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

Brief summary: 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).

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

Eligibility criteria: 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.

Primary outcomes:
measure: PTSD symptom severity
timeFrame: baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks
measure: Treatment retention
timeFrame: 4 weeks, 8 weeks, 18 weeks
measure: Treatment acceptability
timeFrame: 4 weeks, 8 weeks, 18 weeks, 30 weeks
Secondary outcomes:
measure: Trauma coping
timeFrame: baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks
measure: Treatment expectancy
timeFrame: baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks
measure: Mental health stigma
timeFrame: baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks
measure: Medical mistrust
timeFrame: baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks
measure: Posttraumatic cognitions
timeFrame: baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks
measure: Pathological fear extinction
timeFrame: baseline, 4 weeks, 8 weeks, 18 weeks, 30 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center, Psychiatry
name: Sarah Valentine, PhD
role: PRINCIPAL_INVESTIGATOR
References: