Web-administered STAIR for Patients on Behavioral Health Waitlists
- Conditions
- Post Traumatic Stress Disorder
- Interventions
- Behavioral: webSTAIRBehavioral: CHW coaching
- Registration Number
- NCT06431022
- Lead Sponsor
- Boston Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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).
- Patient declines to be in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Self-directed webSTAIR 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). webSTAIR with coaching from a Community Health Worker (CHW) webSTAIR 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. webSTAIR with coaching from a Community Health Worker (CHW) CHW coaching 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.
- Primary Outcome Measures
Name Time Method Feasibility based on assessment completion rate 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 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 3 months The recruitment rate will be calculated by dividing the number of participants by the total number of eligible participants.
Client satisfaction 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 Outcome Measures
Name Time Method PTSD Checklist for DSM-5 (PCL-5) baseline, 3 months, 6 months The PCL-5 is a 20-item self-report checklist of PTSD symptoms based on the DSM-5 criteria1. It measures the degree to which respondents have been bothered by each symptom over the past month or week. To score the PCL-5, a cut-off raw score of 38 is used for a provisional diagnosis of PTSD. Additionally, the DSM-5 diagnostic rule requires at least one symptom from cluster B (questions 1-5), one from cluster C (questions 6-7), two from cluster D (questions 8-14), and two from cluster E (questions 15-20).
Work and Social Functioning (WSAS) baseline, 3 months, 6 months The WSAS is scored using a 9-point Likert-type scale ranging from 0 (no impairment) to 8 (severe impairment). Potential scores range from 0 to 40 with higher scores indicating higher levels of impairment in the assessed areas of a respondent's life.
Trauma Symptoms of Discrimination (TSDS) baseline, 3 months, 6 months The Trauma Symptoms of Discrimination Scale (TSDS) is a 21 item self-report measure designed to assess the traumatizing impact of discrimination broadly by measuring anxiety-related symptoms of trauma due to discriminatory experiences. Participants report the frequency of their experience of discriminatory distress regarding trauma on a 4-point scale ranging from 0 (Never) to 3 (Often). Scores can range from 0 to 63 and higher scores are associated with more trauma symptoms of discrimination.
Trial Locations
- Locations (1)
Boston Medical Center
🇺🇸Boston, Massachusetts, United States