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OpenTrials
Completed

NCT Number: NCT06431022

Web-administered STAIR 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.

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Key information

Conditions

Post Traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

CHW coaching

Behavioral

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

Primary outcomes

  1. Feasibility based on recruitment rate

    Time frame: 3 months

    The recruitment rate will be calculated by dividing the number of participants by the total number of eligible participants.

  2. Feasibility based on assessment completion rate

    Time frame: 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.

  3. Feasibility based on attendance rate

    Time frame: 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.

  4. Client satisfaction

    Time frame: 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 outcomes

  1. PTSD Checklist for DSM-5 (PCL-5)

    Time frame: 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).

  2. Trauma Symptoms of Discrimination (TSDS)

    Time frame: 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.

  3. Work and Social Functioning (WSAS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Registry information

Official study title

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

Acronym: webSTAIR

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 28, 2024
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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