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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Boston Medical Center
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Feasibility based on assessment completion rate
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 (Behavioral)
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 (Behavioral)
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 (Behavioral)
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)