Web-administered STAIR for Patients on Behavioral Health Waitlists (webSTAIR)

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

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 Overview

• Status: Completed
• Conditions: Post Traumatic Stress Disorder
• Intervention / Treatment: Behavioral: webSTAIR; Behavioral: CHW coaching

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Behavioral: webSTAIR; WebSTAIR is a self-paced, brief skills-focused treatment for PTSD that focused on improving one's ability to manage emotions and relationships.
Active Comparator: 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.	Behavioral: webSTAIR; WebSTAIR is a self-paced, brief skills-focused treatment for PTSD that focused on improving one's ability to manage emotions and relationships.; Behavioral: CHW coaching; CHWs will provide webSTAIR coaching, which includes motivational, problem solving, and cognitive-behavioral strategies to enhance skills practice and engagement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility based on recruitment rate	The recruitment rate will be calculated by dividing the number of participants by the total number of eligible participants.	3 months
Feasibility based on assessment completion rate	The proportion of assessments completed will be calculated by dividing the number of assessments completed by the total number of participants.	3 months, 6 months
Feasibility based on attendance rate	The attendance rate will be calculated by dividing the number of webSTAIR sessions attended by the potential number of webSTAIR sessions for each participant.	3 months
Client satisfaction	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.	3 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTSD Checklist for DSM-5 (PCL-5)	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).	baseline, 3 months, 6 months
Trauma Symptoms of Discrimination (TSDS)	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.	baseline, 3 months, 6 months
Work and Social Functioning (WSAS)	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.	baseline, 3 months, 6 months

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Investigators: Principal Investigator: Sarah Valentine, PhD, Boston Medical Center, Psychiatry Department

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2024
• Primary Completion (Actual): May 10, 2026
• Study Completion (Actual): May 10, 2026

Study Registration Dates

• First Submitted: May 22, 2024
• First Submitted That Met QC Criteria: May 22, 2024
• First Posted (Actual): May 28, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Community health worker (CHW); Stepped care; Digital mental health intervention (DMHI); Web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR)
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: H-44467

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No