## Protocol Section
### Identification Module
**NCT ID:** NCT06431022

**Acronym:** webSTAIR

**Brief Title:** Web-administered STAIR for Patients on Behavioral Health Waitlists

**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

#### Organization Study ID Info
**ID:** H-44467
#### Organization
**Class:** OTHER
**Full Name:** Boston Medical Center
### Status Module
#### Completion Date
**Date:** 2025-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Boston Medical Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 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.

### Conditions Module

**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

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 80

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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).

**Intervention Names:**

- Behavioral: webSTAIR

**Label:** Self-directed webSTAIR

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Behavioral: webSTAIR

- Behavioral: CHW coaching

**Label:** webSTAIR with coaching from a Community Health Worker (CHW)

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Self-directed webSTAIR

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

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

**Name:** webSTAIR

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

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

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

**Name:** CHW coaching

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Feasibility based on recruitment rate

**Time Frame:** 3 months

**Description:** The proportion of assessments completed will be calculated by dividing the number of assessments completed by the total number of participants.

**Measure:** Feasibility based on assessment completion rate

**Time Frame:** 3 months, 6 months

**Description:** The attendance rate will be calculated by dividing the number of webSTAIR sessions attended by the potential number of webSTAIR sessions for each participant.

**Measure:** Feasibility based on attendance rate

**Time Frame:** 3 months

**Description:** 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.

**Measure:** Client satisfaction

**Time Frame:** 3 months, 6 months

#### Secondary Outcomes

**Description:** 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).

**Measure:** PTSD Checklist for DSM-5 (PCL-5)

**Time Frame:** baseline, 3 months, 6 months

**Description:** 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.

**Measure:** Trauma Symptoms of Discrimination (TSDS)

**Time Frame:** baseline, 3 months, 6 months

**Description:** 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.

**Measure:** Work and Social Functioning (WSAS)

**Time Frame:** baseline, 3 months, 6 months

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** sarah.valentine@bmc.org

**Name:** Sarah Valentine, PhD

**Phone:** (617) 414-1989

**Role:** CONTACT

**Contact 2:**

**Email:** nuha.alshabani@bmc.org

**Name:** Nuha Alshabani, PhD

**Phone:** (617) 414-1989

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Boston Medical Center, Psychiatry Department

**Name:** Sarah Valentine, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000068099

- Term: Trauma and Stressor Related Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC26

- Name: Wounds and Injuries

### Condition Browse Module - Browse Leaves

- ID: M24916

- Name: Stress Disorders, Traumatic

- Relevance: HIGH

- As Found: Stress Disorder

- ID: M16103

- Name: Stress Disorders, Post-Traumatic

- Relevance: HIGH

- As Found: Post Traumatic Stress Disorder

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M222

- Name: Trauma and Stressor Related Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000040921

- Term: Stress Disorders, Traumatic

- ID: D000013313

- Term: Stress Disorders, Post-Traumatic

### Misc Info Module

- Version Holder: 2024-05-31
