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Intervention to Reduce Safety Behaviors

Primary Purpose

Social Anxiety

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DSB-I
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Social Anxiety focused on measuring Veteran, Social Anxiety, workforce

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ralph H. Johnson VA Medical Center, Charleston, SC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DSB-Intervention

Arm Description

Active intervention group receives text message intervention via ANNIE for 30 days

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
August 9, 2023
Last Updated
August 9, 2023
Sponsor
VA Office of Research and Development
Collaborators
Ralph H. Johnson VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05996419
Brief Title
Intervention to Reduce Safety Behaviors
Official Title
Improving Psychosocial Functioning Among Veterans With Social Anxiety: A Pilot Evaluation of Self-Monitoring Intervention to Reduce Safety Behaviors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
November 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Ralph H. Johnson VA Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety
Keywords
Veteran, Social Anxiety, workforce

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
open trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DSB-Intervention
Arm Type
Experimental
Arm Description
Active intervention group receives text message intervention via ANNIE for 30 days
Intervention Type
Other
Intervention Name(s)
DSB-I
Intervention Description
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 Outcome Measure Information:
Title
Subtle Avoidance Frequency Examination (SAFE)
Description
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
Title
Social Phobia Inventory (SPIN)
Description
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
Other Pre-specified Outcome Measures:
Title
General Self-Efficacy Scale (GSE)
Description
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
Title
PTSD Checklist (PCL-5)
Description
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
Title
Patient Health Questionnaire (PHQ-9)
Description
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
Title
Quality of Life Scale (QOL)
Description
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
Baseline and immediately after intervention
Title
Rate of recruitment
Description
Proportion of veterans who agree to participate compared to total number approached for enrollment
Time Frame
18 month (end of recruitment)
Title
THE VETERANS RAND 12-ITEM HEALTH SURVEY (SF-12)
Description
valid and reliable instrument to measure quality of life/functional status in Veterans
Time Frame
Baseline and immediately after intervention
Title
Rate of retention
Description
Number of veterans who enroll and complete study procedures as well as follow up interview compared to number who enroll
Time Frame
18 month (end of recruitment)
Title
Credibility and Expectancy Questionnaire (CEQ)
Description
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
Baseline
Title
Reactions to the Intervention
Description
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.
Time Frame
immediately after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anouk L Grubaugh, PhD MA BS
Phone
(843) 789-6664
Email
Anouk.Grubaugh@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Szafranski
Phone
(832) 577-5011
Ext
5316
Email
Sarah.Szafranski@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anouk L. Grubaugh, PhD MA BS
Organizational Affiliation
Ralph H. Johnson VA Medical Center, Charleston, SC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ralph H. Johnson VA Medical Center, Charleston, SC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401-5703
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anouk L Grubaugh, PhD MA BS
Phone
843-789-6664
Email
Anouk.Grubaugh@va.gov
First Name & Middle Initial & Last Name & Degree
Anouk L. Grubaugh, PhD MA BS

12. IPD Sharing Statement

Plan to Share IPD
No

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Intervention to Reduce Safety Behaviors

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