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Clinical Trials/NCT06431022
NCT06431022
Active, Not Recruiting
N/A

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

Boston Medical Center1 site in 1 country70 target enrollmentNovember 15, 2024

Overview

Phase
N/A
Intervention
webSTAIR
Conditions
Post Traumatic Stress Disorder
Sponsor
Boston Medical Center
Enrollment
70
Locations
1
Primary Endpoint
Feasibility based on assessment completion rate
Status
Active, Not Recruiting
Last Updated
last month

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 15, 2024
End Date
May 1, 2026
Last Updated
last month
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Arms & Interventions

Self-directed webSTAIR

Participants on the Research, and Education Center (RESTORE) waitlist randomized to this arm will receive the self-managed web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR).

Intervention: webSTAIR

webSTAIR with coaching from a Community Health Worker (CHW)

Participants on the RESTORE waitlist randomized to this arm will receive the web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR) with coaching support from a CHW.

Intervention: webSTAIR

webSTAIR with coaching from a Community Health Worker (CHW)

Participants on the RESTORE waitlist randomized to this arm will receive the web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR) with coaching support from a CHW.

Intervention: CHW coaching

Outcomes

Primary Outcomes

Feasibility based on assessment completion rate

Time Frame: 3 months, 6 months

The proportion of assessments completed will be calculated by dividing the number of assessments completed by the total number of participants.

Feasibility based on attendance rate

Time Frame: 3 months

The attendance rate will be calculated by dividing the number of webSTAIR sessions attended by the potential number of webSTAIR sessions for each participant.

Feasibility based on recruitment rate

Time Frame: 3 months

The recruitment rate will be calculated by dividing the number of participants by the total number of eligible participants.

Client satisfaction

Time Frame: 3 months, 6 months

Client satisfaction/acceptability will be measured by the Client Satisfaction Questionnaire (CSQ-8) which is an 8 item instrument with each item having 4 potential responses form 1 to 4. Scores are summed across items once. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.

Secondary Outcomes

  • PTSD Checklist for DSM-5 (PCL-5)(baseline, 3 months, 6 months)
  • Work and Social Functioning (WSAS)(baseline, 3 months, 6 months)
  • Trauma Symptoms of Discrimination (TSDS)(baseline, 3 months, 6 months)

Study Sites (1)

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