Web-administered STAIR for Patients on Behavioral Health Waitlists

Post Traumatic Stress Disorder Clinical Trial

— webSTAIR  

Official title:

The Feasibility, Acceptability, and Initial Effectiveness of Web-administered Skills Training in Affective and Interpersonal Regulation (webSTAIR) for Posttraumatic Stress Disorder (PTSD) Administered to Patients on Behavioral Health Waitlists

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06431022
• Other study ID #: H-44467
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Boston Medical Center
• Contact: Sarah Valentine, PhD
• Phone: (617) 414-1989
• Email: sarah.valentine[@]bmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 Medinal 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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