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Completed

NCT Number: NCT05996419

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5703, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

Primary outcomes

  1. Subtle Avoidance Frequency Examination (SAFE)

    Time frame: Baseline and immediately after intervention

    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

  2. Social Phobia Inventory (SPIN)

    Time frame: baseline and immediately after intervention

    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

Other outcomes

  1. General Self-Efficacy Scale (GSE)

    Time frame: Baseline and immediately after intervention

    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

  2. PTSD Checklist (PCL-5)

    Time frame: Baseline and immediately after intervention

    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

  3. Patient Health Questionnaire (PHQ-9)

    Time frame: Baseline and immediately after intervention

    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

  4. Quality of Life Scale (QOL)

    Time frame: Baseline and immediately after intervention

    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

  5. Rate of recruitment

    Time frame: 18 month (end of recruitment)

    Proportion of veterans who agree to participate compared to total number approached for enrollment

  6. THE VETERANS RAND 12-ITEM HEALTH SURVEY (SF-12)

    Time frame: Baseline and immediately after intervention

    valid and reliable instrument to measure quality of life/functional status in Veterans

  7. Rate of retention

    Time frame: 18 month (end of recruitment)

    Number of veterans who enroll and complete study procedures as well as follow up interview compared to number who enroll

  8. Credibility and Expectancy Questionnaire (CEQ)

    Time frame: Baseline

    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.

  9. Reactions to the Intervention

    Time frame: immediately after 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • Ralph H. Johnson VA Medical Center

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 18, 2023
Registry last updated
Jan 27, 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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