Intervention to Reduce Safety Behaviors

Improving Psychosocial Functioning Among Veterans With Social Anxiety: A Pilot Evaluation of Self-Monitoring Intervention to Reduce Safety Behaviors

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.

Study Overview

• Status: Completed
• Conditions: Social Anxiety
• Intervention / Treatment: Other: DSB-I

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29401-5703
      • Ralph H. Johnson VA Medical Center, Charleston, SC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DSB-Intervention; Active intervention group receives text message intervention via ANNIE for 30 days	Other: DSB-I; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
General Self-Efficacy Scale (GSE)	10-item self-report measure of self-efficacy. The GSE demonstrates adequate internal reliability and convergent and divergent validity. Items range from 1 to 4 with total scores ranging between 10 and 40 and higher scores indicative of more self-efficacy;, total mean score	Baseline and immediately after intervention
PTSD Checklist (PCL-5)	20-item instrument that parallels DSM-5 criteria for PTSD. Each item has five response options. Scores range from 0-80 with higher scores indicative of PTSD. Measures DSM-5 criteria for PTSD	Baseline and immediately after intervention
Patient Health Questionnaire (PHQ-9)	a brief questionnaire that scores each of the 9 DSM-IV criteria for depression as "0" (not at all) to "3" (nearly every day). PHQ-9 score > or =10 have a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression, respectively , total mean score	Baseline and immediately after intervention
Quality of Life Scale (QOL)	16-item self-report measure of quality of life across 5 conceptual domains: material and physical well-being, relationships with other people, social/community activities, personal development and fulfillment, and recreation, as well as an item on independence. The QOL demonstrates strong internal reliability and validity across medical populations and settings	Baseline and immediately after intervention
Rate of recruitment	Proportion of veterans who agree to participate compared to total number approached for enrollment	18 month (end of recruitment)
THE VETERANS RAND 12-ITEM HEALTH SURVEY (SF-12)	valid and reliable instrument to measure quality of life/functional status in Veterans	Baseline and immediately after intervention
Rate of retention	Number of veterans who enroll and complete study procedures as well as follow up interview compared to number who enroll	18 month (end of recruitment)
Credibility and Expectancy Questionnaire (CEQ)	will be used to assess the perceived credibility and expectancy related to effectiveness of the intervention. The CEQ will be administered only at baseline (following the intervention description), and 3 items from the measure will be used. These include: 1) how logical the program seems; 2) how successful the Veteran believes the program will be for him or her; and 3) how confident the Veteran would be recommending the program to a friend with similar needs.	Baseline
Reactions to the Intervention	This form consists of 3 questions comparable in scaling (i.e., using a 1 to 9 scale) to the CEQ. Specific questions target 1) satisfaction with the program; 2) likelihood of recommending the program to someone else; and 3) degree to which the Veteran believes the program helped with his or her difficulties and/or goals.	immediately after intervention

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: Ralph H. Johnson VA Medical Center
• Investigators: Principal Investigator: Anouk L. Grubaugh, PhD MA BS, Ralph H. Johnson VA Medical Center, Charleston, SC

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): November 28, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: August 9, 2023
• First Submitted That Met QC Criteria: August 9, 2023
• First Posted (Actual): August 18, 2023

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Social Anxiety; Veteran; workforce
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: D4401-P; 121RX004401-01-A1 (Other Grant/Funding Number: Department of Veterans Affairs)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No