Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5703, United States
NCT Number: NCT05996419
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Charleston, South Carolina, 29401-5703, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
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
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
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
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
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
Time frame: 18 month (end of recruitment)
Proportion of veterans who agree to participate compared to total number approached for enrollment
Time frame: Baseline and immediately after intervention
valid and reliable instrument to measure quality of life/functional status in Veterans
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
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.
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.
VA Office of Research and Development
Fed
Improving Psychosocial Functioning Among Veterans With Social Anxiety: A Pilot Evaluation of Self-Monitoring Intervention to Reduce Safety Behaviors
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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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