Clinical trial NCT06431022: Web-administered STAIR for Patients on Behavioral Health Waitlists
Official title: The Feasibility, Acceptability, and Initial Effectiveness of Web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR) for Posttraumatic Stress Disorder (PTSD) for Patients on Behavioral Health Waitlists
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Traumatic Stress Disorder
Keywords: Digital mental health intervention (DMHI)
Community health worker (CHW)
Web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR)
Stepped care
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Posttraumatic stress disorder (PTSD) is a significant public health challenge with population prevalence rates in the US between 6.1 to 9.2%. There are large racial and socioeconomic inequities in access to PTSD treatment, as up to half (30-50%) of patients in safety net clinical settings meet criteria for PTSD, yet only 13% receive any behavioral health treatment. Workforce shortages are one major barrier to accessing care. Additional barriers to care can include heightened mental health stigma and mistrust of health services.

Digital mental health interventions (DMHIs) may be suitable within the continuum of care for PTSD in hospital settings, given their potential for rapid-access, scalability, and the high acceptability of DMHI among individuals with high stigma and social needs. Among the available DMHIs for PTSD, the investigators have selected web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR), based on emerging scientific evidence and a close collaboration with Boston Medical Center (BMC) users (patients and providers) in a previous pilot study in primary care.

The aim of this randomized study is to implement webSTAIR at BMC in the Recovery from Stress and Trauma through Outpatient Care, Research, and Education (RESTORE) Center's subspecialty clinic.


Eligibility criteria: Inclusion Criteria:

* Client on the RESTORE Center waitlist at Boston Medical Center
* Over 18 years of age
* Able to receive therapy in English or Spanish (per participant report)
* Exposure to trauma (as indicated by the Life Events Checklist for the DSM-5 \[LEC-5\])
* Probable PTSD (as indicated by the PTSD Checklist for the DSM-5 \[PCL-5\] based on PCL score of 33+).
* Reasonable to access to technology (e.g., phone, computer, internet access).

Exclusion Criteria:

* Patient declines to be in the study.

Primary outcomes:
measure: Feasibility based on recruitment rate
timeFrame: 3 months
measure: Feasibility based on assessment completion rate
timeFrame: 3 months, 6 months
measure: Feasibility based on attendance rate
timeFrame: 3 months
measure: Client satisfaction
timeFrame: 3 months, 6 months
Secondary outcomes:
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: baseline, 3 months, 6 months
measure: Trauma Symptoms of Discrimination (TSDS)
timeFrame: baseline, 3 months, 6 months
measure: Work and Social Functioning (WSAS)
timeFrame: baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center, Psychiatry Department
name: Sarah Valentine, PhD
role: PRINCIPAL_INVESTIGATOR
References: