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| ID | Type | Description | Link |
|---|---|---|---|
| 121RX004401-01-A1 | Other Grant/Funding Number | Department of Veterans Affairs |
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| Name | Class |
|---|---|
| Ralph H. Johnson VA Medical Center | FED |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DSB-Intervention | Experimental | Active intervention group receives text message intervention via ANNIE for 30 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anouk L. Grubaugh, PhD MA BS | Ralph H. Johnson VA Medical Center, Charleston, SC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ralph H. Johnson VA Medical Center, Charleston, SC | Charleston | South Carolina | 29401-5703 | United States |
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open trial
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| 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 |