Web-administered STAIR for Patients on Behavioral Health Waitlists

NCT06431022 | Active Not Recruiting

• 1 other identifier: H-44467
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• PTSD Checklist for DSM-5 (PCL-5)

  baseline, 3 months, 6 months

• Trauma Symptoms of Discrimination (TSDS)

  baseline, 3 months, 6 months

• Work and Social Functioning (WSAS)

  baseline, 3 months, 6 months

Study Arms (2)

Self-directed webSTAIR

EXPERIMENTAL

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 with coaching from a Community Health Worker (CHW)

ACTIVE COMPARATOR

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; Behavioral: CHW coaching

Interventions

webSTAIR BEHAVIORAL

WebSTAIR is a self-paced, brief skills-focused treatment for PTSD that focused on improving one's ability to manage emotions and relationships.

Self-directed webSTAIR; webSTAIR with coaching from a Community Health Worker (CHW)

CHW coaching BEHAVIORAL

CHWs will provide webSTAIR coaching, which includes motivational, problem solving, and cognitive-behavioral strategies to enhance skills practice and engagement.

webSTAIR with coaching from a Community Health Worker (CHW)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Patient declines to be in the study.

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Sarah Valentine, PhD

  Boston Medical Center, Psychiatry Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: May 28, 2024
• Study Start: November 15, 2024
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)