Intervention to Reduce Safety Behaviors

NCT05996419 | Completed

• 2 other identifiers: D4401-P121RX004401-01-A1
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Social anxiety is associated with significant deficits in social and occupational functioning. The proposed study seeks to evaluate the feasibility of implementing a brief text-based intervention for decreasing social anxiety related safety behaviors among Veterans attempting to re-integrate into the workforce. Findings from this pilot will support a larger randomized controlled study examining the efficacy of the intervention for improving functional outcomes and quality of life among Veterans.

Conditions

Social Anxiety

Keywords

Veteran; Social Anxiety; workforce

Outcome Measures

Primary Outcomes (2)

• Subtle Avoidance Frequency Examination (SAFE)

  32-item self-report measure designed to assess the frequency of safety behavior (SB) use. Respondents are asked to rate how often they engage in SBs such as "Rehearse sentences in your mind" and "Avoid eye contact" on a scale of 0 (Never) to 4 (Always). Scores on the SAFE range from 0-128 with higher scores indicative or more safety behavior use. total mean score

  Baseline and immediately after intervention

• Social Phobia Inventory (SPIN)

  17-item measure of social anxiety severity. Participants are asked to rate items such as "I avoid doing things or speaking to people for fear of embarrassment" on a Likert-type scale of 0 (Not at all) to 4 (Extremely). Scores on the SPIN range from 0 to 68 with higher scores indicative of more severe social anxiety, total mean score

  baseline and immediately after intervention

Other Outcomes (9)

• General Self-Efficacy Scale (GSE)

  Baseline and immediately after intervention

• PTSD Checklist (PCL-5)

  Baseline and immediately after intervention

• Patient Health Questionnaire (PHQ-9)

  Baseline and immediately after intervention

Study Arms (1)

DSB-Intervention

EXPERIMENTAL

Active intervention group receives text message intervention via ANNIE for 30 days

Other: DSB-I

Interventions

DSB-I OTHER

Participant will receive text message every other day during active phase (30days) via ANNIE text messaging app related to the safety behaviors they identified prior to start.

DSB-Intervention

Eligibility Criteria

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

You may qualify if:

• Active enrollment in Compensated Work Therapy
• Score of \> 25 on the Social Phobia Inventory
• Score of \> 47 on the Subtle Avoidance Frequency Examination

You may not qualify if:

• Concurrent enrollment in another study related to social anxiety or improving functional status
• Recent (\<3 month) history of psychiatric hospitalization, detoxification admission, or suicide attempt

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Ralph H. Johnson VA Medical Center: collaborator

Study Sites (1)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5703, United States

Location

Study Officials

• Anouk L. Grubaugh, PhD MA BS

  Ralph H. Johnson VA Medical Center, Charleston, SC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: open trial

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 18, 2023
• Study Start: July 1, 2024
• Primary Completion: November 28, 2025
• Study Completion: December 31, 2025
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)