Intervention to Reduce Safety Behaviors

Social Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05996419
• Other study ID #: D4401-P
• Secondary ID: 121RX004401-01-A
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 3, 2024
• Est. completion date: November 30, 2025

Study information

• Verified date: May 2024
• Source: VA Office of Research and Development
• Contact: Anouk L Grubaugh, PhD MA BS
• Phone: (843) 789-6664
• Email: Anouk.Grubaugh[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: November 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Social Anxiety

Intervention

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.

Locations

Country	Name	City	State
United States	Ralph H. Johnson VA Medical Center, Charleston, SC	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Ralph H. Johnson VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	Rate of recruitment	Proportion of veterans who agree to participate compared to total number approached for enrollment	18 month (end of recruitment)
Other	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
Other	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)
Other	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
Other	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
Primary	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
Primary	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