<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/NCT02265211</url>
  </required_header>
  <id_info>
    <org_study_id>4207</org_study_id>
    <nct_id>NCT02265211</nct_id>
  </id_info>
  <brief_title>Mindfulness and Acceptance-Based Treatments for Social Anxiety: Defusion App</brief_title>
  <official_title>Mindfulness and Acceptance-Based Treatments for Social Anxiety: Defusion App</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wilfrid Laurier University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wilfrid Laurier University</source>
  <brief_summary>
    <textblock>
      This study evaluates a self-help app in the treatment of shyness and social anxiety in&#xD;
      adults. All participants will be assigned to the treatment group. It is expected that using&#xD;
      this app will result in a reduction in social anxiety.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Over 2 million Canadians have suffered from social anxiety disorder (SAD) at some point in&#xD;
      their lives. This disorder is characterized by a strong fear of negative evaluation in social&#xD;
      situations and is associated with significant impairment in social interactions,&#xD;
      educational/occupational achievement, and life satisfaction. Despite the fact that&#xD;
      efficacious treatments have been developed and evaluated, both treatment effectiveness and&#xD;
      treatment seeking behaviour remain below optimal levels. Combined with the many barriers to&#xD;
      treatment (i.e., cost, stigma, access), researchers are investigating self-help modalities as&#xD;
      an alternative to conventional psychotherapy.&#xD;
&#xD;
      The Defusion App is based on content from Fleming &amp; Kocovski's (2013) self-help book &quot;The&#xD;
      Mindfulness &amp; Acceptance Workbook for Social Anxiety &amp; Shyness.&quot; Specifically, the app&#xD;
      teaches users about the tendency of socially anxious individuals to fuse with their anxious&#xD;
      thoughts (i.e., cognitive fusion), and strategies to reduce it.&#xD;
&#xD;
      In this experimental research study, a smartphone app designed to help with social anxiety&#xD;
      and shyness will be evaluated for both effectiveness and frequency of use. The objectives&#xD;
      will be to determine whether participants use the app, and whether use of the app is&#xD;
      associated with a reduction in social anxiety.&#xD;
&#xD;
      Preliminary evidence has indicated that smartphone apps for mental health are associated with&#xD;
      promising results. It is expected that the use of the app in the present research will be&#xD;
      associated with reductions in social anxiety symptom severity and a greater use of cognitive&#xD;
      defusion strategies.&#xD;
&#xD;
      The participants will be a community sample of individuals interested in seeking help with&#xD;
      social anxiety and shyness as recruited by the use of posters around the Wilfrid Laurier&#xD;
      University campus and in the community, as well as online.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in Social Anxiety Interaction Scale at 7 days</measure>
    <time_frame>Baseline and 7 days</time_frame>
    <description>Self-reported social anxiety scores. Each item is scored 0 (not at all ) to 4 (extremely) yielding a total between 0 and 80.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in Social Phobia Scale at 7 days</measure>
    <time_frame>baseline and 7 days</time_frame>
    <description>Self-reported social anxiety scores. Each item is scored 0 (not at all ) to 4 (extremely) yielding a total between 0 and 80.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in Cognitive Fusion Questionnaire at 7 days</measure>
    <time_frame>baseline and 7 days</time_frame>
    <description>Self-reported cognitive fusion scores. Each item is scored 1 (never true ) to 7 (always true) yielding a total between 7 and 49.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in Believability of Anxious Feelings and Thoughts Questionnaire at 7 days</measure>
    <time_frame>baseline and 7 days</time_frame>
    <description>Self-reported believability of anxious feelings and thoughts scores. Each item is scored 1 (not at all believable) to 7 (completely believable) yielding a total between 16 and 112.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in Experiences Questionnaire at 7 days</measure>
    <time_frame>baseline and 7 days</time_frame>
    <description>Self-reported decentering scores. Each item is rated from 1 (never) to 5 (all the time) yielding a total between 20 and 100.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in Brief Social Anxiety - Acceptance and Action Questionnaire at 7 days</measure>
    <time_frame>baseline and 7 days</time_frame>
    <description>Self-reported acceptance of social anxiety scores. Each item is rated from 1 (never true) to 5 (always true) yielding a total between 1 and 56..</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Readiness Ruler</measure>
    <time_frame>baseline</time_frame>
    <description>Self-reported readiness to change ruler. Participants indicate the degree to which they are ready to change on a visual analogue scale ranging from 0 (not prepared to change) to 10 (already changing).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Credibility/Expectancy Questionnaire</measure>
    <time_frame>baseline</time_frame>
    <description>Self-reported app credibility. Participants indicate how credible the treatment app seems.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Anxiety</condition>
  <condition>Shyness</condition>
  <arm_group>
    <arm_group_label>Self-Help App</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Smartphone app designed to teach cognitive defusion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Self-Help App</intervention_name>
    <arm_group_label>Self-Help App</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  must be seeking help for shyness/social anxiety&#xD;
&#xD;
          -  must own a smartphone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Meagan B MacKenzie, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wilfrid Laurier University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wilfrid Laurier University</name>
      <address>
        <city>Waterloo</city>
        <state>Ontario</state>
        <zip>N2L 3C5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>October 6, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>June 15, 2015</last_update_submitted>
  <last_update_submitted_qc>June 15, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 16, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wilfrid Laurier University</investigator_affiliation>
    <investigator_full_name>Meagan MacKenzie</investigator_full_name>
    <investigator_title>Postdoctoral Fellow</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02265211
org study id: 4207
nct id: NCT02265211
lead sponsor: 
This study evaluates a self-help app in the treatment of shyness and social anxiety in
      adults. All participants will be assigned to the treatment group. It is expected that using
      this app will result in a reduction in social anxiety.
Over 2 million Canadians have suffered from social anxiety disorder (SAD) at some point in
      their lives. This disorder is characterized by a strong fear of negative evaluation in social
      situations and is associated with significant impairment in social interactions,
      educational/occupational achievement, and life satisfaction. Despite the fact that
      efficacious treatments have been developed and evaluated, both treatment effectiveness and
      treatment seeking behaviour remain below optimal levels. Combined with the many barriers to
      treatment (i.e., cost, stigma, access), researchers are investigating self-help modalities as
      an alternative to conventional psychotherapy.

      The Defusion App is based on content from Fleming & Kocovski's (2013) self-help book "The
      Mindfulness & Acceptance Workbook for Social Anxiety & Shyness." Specifically, the app
      teaches users about the tendency of socially anxious individuals to fuse with their anxious
      thoughts (i.e., cognitive fusion), and strategies to reduce it.

      In this experimental research study, a smartphone app designed to help with social anxiety
      and shyness will be evaluated for both effectiveness and frequency of use. The objectives
      will be to determine whether participants use the app, and whether use of the app is
      associated with a reduction in social anxiety.

      Preliminary evidence has indicated that smartphone apps for mental health are associated with
      promising results. It is expected that the use of the app in the present research will be
      associated with reductions in social anxiety symptom severity and a greater use of cognitive
      defusion strategies.

      The participants will be a community sample of individuals interested in seeking help with
      social anxiety and shyness as recruited by the use of posters around the Wilfrid Laurier
      University campus and in the community, as well as online.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from Baseline in Social Anxiety Interaction Scale at 7 days
time frame: Baseline and 7 days
description: Self-reported social anxiety scores. Each item is scored 0 (not at all ) to 4 (extremely) yielding a total between 0 and 80.
measure: Change from Baseline in Social Phobia Scale at 7 days
time frame: baseline and 7 days
description: Self-reported social anxiety scores. Each item is scored 0 (not at all ) to 4 (extremely) yielding a total between 0 and 80.
measure: Change from Baseline in Cognitive Fusion Questionnaire at 7 days
time frame: baseline and 7 days
description: Self-reported cognitive fusion scores. Each item is scored 1 (never true ) to 7 (always true) yielding a total between 7 and 49.
measure: Change from Baseline in Believability of Anxious Feelings and Thoughts Questionnaire at 7 days
time frame: baseline and 7 days
description: Self-reported believability of anxious feelings and thoughts scores. Each item is scored 1 (not at all believable) to 7 (completely believable) yielding a total between 16 and 112.
measure: Change from Baseline in Experiences Questionnaire at 7 days
time frame: baseline and 7 days
description: Self-reported decentering scores. Each item is rated from 1 (never) to 5 (all the time) yielding a total between 20 and 100.
measure: Change from Baseline in Brief Social Anxiety - Acceptance and Action Questionnaire at 7 days
time frame: baseline and 7 days
description: Self-reported acceptance of social anxiety scores. Each item is rated from 1 (never true) to 5 (always true) yielding a total between 1 and 56..
measure: Readiness Ruler
time frame: baseline
description: Self-reported readiness to change ruler. Participants indicate the degree to which they are ready to change on a visual analogue scale ranging from 0 (not prepared to change) to 10 (already changing).
measure: Credibility/Expectancy Questionnaire
time frame: baseline
description: Self-reported app credibility. Participants indicate how credible the treatment app seems.
arm group label: Self-Help App
arm group type: Experimental
description: Smartphone app designed to teach cognitive defusion.
intervention type: Behavioral
intervention name: Self-Help App
arm group label: Self-Help App
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Meagan B MacKenzie, Ph.D.
role: Principal Investigator
affiliation: Wilfrid Laurier University
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Wilfrid Laurier University
investigator full name: Meagan MacKenzie
investigator title: Postdoctoral Fellow
mesh term: Anxiety Disorders