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Web-administered STAIR for Patients on Behavioral Health Waitlists

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06431022
Acronym
webSTAIR
Enrollment
70
Registered
2024-05-28
Start date
2024-11-15
Completion date
2026-06-05
Last updated
2026-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

BEHAVIORALwebSTAIR

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

BEHAVIORALCHW coaching

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

Sponsors

Boston Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Feasibility based on recruitment rate3 monthsThe recruitment rate will be calculated by dividing the number of participants by the total number of eligible participants.
Feasibility based on assessment completion rate3 months, 6 monthsThe proportion of assessments completed will be calculated by dividing the number of assessments completed by the total number of participants.
Feasibility based on attendance rate3 monthsThe attendance rate will be calculated by dividing the number of webSTAIR sessions attended by the potential number of webSTAIR sessions for each participant.
Client satisfaction3 months, 6 monthsClient 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

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

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSarah Valentine, PhD

Boston Medical Center, Psychiatry Department

PRINCIPAL_INVESTIGATORNuha Alshabani, PhD

Boston Medical Center, Psychiatry Department

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 7, 2026