xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05996419</url>
    </required_header>
    <id_info>
      <org_study_id>D4401-P</org_study_id>
      <secondary_id>121RX004401-01-A1</secondary_id>
      <nct_id>NCT05996419</nct_id>
    </id_info>
    <brief_title>Intervention to Reduce Safety Behaviors</brief_title>
    <official_title>Improving Psychosocial Functioning Among Veterans With Social Anxiety: A Pilot Evaluation of Self-Monitoring Intervention to Reduce Safety Behaviors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>VA Office of Research and Development</agency>
        <agency_class>U.S. Fed</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Ralph H. Johnson VA Medical Center</agency>
        <agency_class>U.S. Fed</agency_class>
      </collaborator>
    </sponsors>
    <source>VA Office of Research and Development</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Social anxiety is associated with significant deficits in social and occupational&#xD;
        functioning. The proposed study seeks to evaluate the feasibility of implementing a brief&#xD;
        text-based intervention for decreasing social anxiety related safety behaviors among Veterans&#xD;
        attempting to re-integrate into the workforce. Findings from this pilot will support a larger&#xD;
        randomized controlled study examining the efficacy of the intervention for improving&#xD;
        functional outcomes and quality of life among Veterans.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 1, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>open trial</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Subtle Avoidance Frequency Examination (SAFE)</measure>
      <time_frame>Baseline and immediately after intervention</time_frame>
      <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 &quot;Rehearse sentences in your mind&quot; and &quot;Avoid eye contact&quot; 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</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Social Phobia Inventory (SPIN)</measure>
      <time_frame>baseline and immediately after intervention</time_frame>
      <description>17-item measure of social anxiety severity. Participants are asked to rate items such as &quot;I avoid doing things or speaking to people for fear of embarrassment&quot; 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</description>
    </primary_outcome>
    <other_outcome>
      <measure>General Self-Efficacy Scale (GSE)</measure>
      <time_frame>Baseline and immediately after intervention</time_frame>
      <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</description>
    </other_outcome>
    <other_outcome>
      <measure>PTSD Checklist (PCL-5)</measure>
      <time_frame>Baseline and immediately after intervention</time_frame>
      <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</description>
    </other_outcome>
    <other_outcome>
      <measure>Patient Health Questionnaire (PHQ-9)</measure>
      <time_frame>Baseline and immediately after intervention</time_frame>
      <description>a brief questionnaire that scores each of the 9 DSM-IV criteria for depression as &quot;0&quot; (not at all) to &quot;3&quot; (nearly every day). PHQ-9 score &gt; 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</description>
    </other_outcome>
    <other_outcome>
      <measure>Quality of Life Scale (QOL)</measure>
      <time_frame>Baseline and immediately after intervention</time_frame>
      <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</description>
    </other_outcome>
    <other_outcome>
      <measure>Rate of recruitment</measure>
      <time_frame>18 month (end of recruitment)</time_frame>
      <description>Proportion of veterans who agree to participate compared to total number approached for enrollment</description>
    </other_outcome>
    <other_outcome>
      <measure>THE VETERANS RAND 12-ITEM HEALTH SURVEY (SF-12)</measure>
      <time_frame>Baseline and immediately after intervention</time_frame>
      <description>valid and reliable instrument to measure quality of life/functional status in Veterans</description>
    </other_outcome>
    <other_outcome>
      <measure>Rate of retention</measure>
      <time_frame>18 month (end of recruitment)</time_frame>
      <description>Number of veterans who enroll and complete study procedures as well as follow up interview compared to number who enroll</description>
    </other_outcome>
    <other_outcome>
      <measure>Credibility and Expectancy Questionnaire (CEQ)</measure>
      <time_frame>Baseline</time_frame>
      <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.</description>
    </other_outcome>
    <other_outcome>
      <measure>Reactions to the Intervention</measure>
      <time_frame>immediately after intervention</time_frame>
      <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.</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Social Anxiety</condition>
    <arm_group>
      <arm_group_label>DSB-Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Active intervention group receives text message intervention via ANNIE for 30 days</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>DSB-I</intervention_name>
      <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.</description>
      <arm_group_label>DSB-Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Active enrollment in Compensated Work Therapy&#xD;
  &#xD;
            -  Score of &gt; 25 on the Social Phobia Inventory&#xD;
  &#xD;
            -  Score of &gt; 47 on the Subtle Avoidance Frequency Examination&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Concurrent enrollment in another study related to social anxiety or improving&#xD;
               functional status&#xD;
  &#xD;
            -  Recent (&lt;3 month) history of psychiatric hospitalization, detoxification admission, or&#xD;
               suicide attempt&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Anouk L. Grubaugh, PhD MA BS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Ralph H. Johnson VA Medical Center, Charleston, SC</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Anouk L Grubaugh, PhD MA BS</last_name>
      <phone>(843) 789-6664</phone>
      <email>Anouk.Grubaugh@va.gov</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sarah Szafranski</last_name>
      <phone>(832) 577-5011</phone>
      <phone_ext>5316</phone_ext>
      <email>Sarah.Szafranski@va.gov</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Ralph H. Johnson VA Medical Center, Charleston, SC</name>
        <address>
          <city>Charleston</city>
          <state>South Carolina</state>
          <zip>29401-5703</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Anouk L Grubaugh, PhD MA BS</last_name>
        <phone>843-789-6664</phone>
        <email>Anouk.Grubaugh@va.gov</email>
      </contact>
      <investigator>
        <last_name>Anouk L. Grubaugh, PhD MA BS</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Veteran</keyword>
    <keyword>Social Anxiety</keyword>
    <keyword>workforce</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anxiety Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05996419
  org study id: D4401-P
  secondary id: 121RX004401-01-A1
  nct id: NCT05996419
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  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.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: open trial
  primary purpose: Other
  masking: None (Open Label)
  measure: Subtle Avoidance Frequency Examination (SAFE)
  time frame: Baseline and immediately after intervention
  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
  measure: Social Phobia Inventory (SPIN)
  time frame: baseline and immediately after intervention
  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
  measure: General Self-Efficacy Scale (GSE)
  time frame: Baseline and immediately after intervention
  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
  measure: PTSD Checklist (PCL-5)
  time frame: Baseline and immediately after intervention
  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
  measure: Patient Health Questionnaire (PHQ-9)
  time frame: Baseline and immediately after intervention
  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
  measure: Quality of Life Scale (QOL)
  time frame: Baseline and immediately after intervention
  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
  measure: Rate of recruitment
  time frame: 18 month (end of recruitment)
  description: Proportion of veterans who agree to participate compared to total number approached for enrollment
  measure: THE VETERANS RAND 12-ITEM HEALTH SURVEY (SF-12)
  time frame: Baseline and immediately after intervention
  description: valid and reliable instrument to measure quality of life/functional status in Veterans
  measure: Rate of retention
  time frame: 18 month (end of recruitment)
  description: Number of veterans who enroll and complete study procedures as well as follow up interview compared to number who enroll
  measure: Credibility and Expectancy Questionnaire (CEQ)
  time frame: Baseline
  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.
  measure: Reactions to the Intervention
  time frame: immediately after 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.
  arm group label: DSB-Intervention
  arm group type: Experimental
  description: Active intervention group receives text message intervention via ANNIE for 30 days
  intervention type: Other
  intervention name: DSB-I
  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.
  arm group label: DSB-Intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Anouk L. Grubaugh, PhD MA BS
  role: Principal Investigator
  affiliation: Ralph H. Johnson VA Medical Center, Charleston, SC
  last name: Anouk L Grubaugh, PhD MA BS
  phone: (843) 789-6664
  email: Anouk.Grubaugh@va.gov
  last name: Sarah Szafranski
  phone: (832) 577-5011
  phone ext: 5316
  email: Sarah.Szafranski@va.gov
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Anxiety Disorders
  sharing ipd: No