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Mindfulness and Acceptance-Based Treatments for Social Anxiety: Defusion App

Primary Purpose

Anxiety, Shyness

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Self-Help App
Sponsored by
Wilfrid Laurier University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • must be seeking help for shyness/social anxiety
  • must own a smartphone

Exclusion Criteria:

  • none

Sites / Locations

  • Wilfrid Laurier University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Self-Help App

Arm Description

Smartphone app designed to teach cognitive defusion.

Outcomes

Primary Outcome Measures

Change from Baseline in Social Anxiety Interaction Scale at 7 days
Self-reported social anxiety scores. Each item is scored 0 (not at all ) to 4 (extremely) yielding a total between 0 and 80.
Change from Baseline in Social Phobia Scale at 7 days
Self-reported social anxiety scores. Each item is scored 0 (not at all ) to 4 (extremely) yielding a total between 0 and 80.
Change from Baseline in Cognitive Fusion Questionnaire at 7 days
Self-reported cognitive fusion scores. Each item is scored 1 (never true ) to 7 (always true) yielding a total between 7 and 49.
Change from Baseline in Believability of Anxious Feelings and Thoughts Questionnaire at 7 days
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.
Change from Baseline in Experiences Questionnaire at 7 days
Self-reported decentering scores. Each item is rated from 1 (never) to 5 (all the time) yielding a total between 20 and 100.
Change from Baseline in Brief Social Anxiety - Acceptance and Action Questionnaire at 7 days
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..

Secondary Outcome Measures

Readiness Ruler
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).
Credibility/Expectancy Questionnaire
Self-reported app credibility. Participants indicate how credible the treatment app seems.

Full Information

First Posted
October 6, 2014
Last Updated
June 15, 2015
Sponsor
Wilfrid Laurier University
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1. Study Identification

Unique Protocol Identification Number
NCT02265211
Brief Title
Mindfulness and Acceptance-Based Treatments for Social Anxiety: Defusion App
Official Title
Mindfulness and Acceptance-Based Treatments for Social Anxiety: Defusion App
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wilfrid Laurier University

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Shyness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-Help App
Arm Type
Experimental
Arm Description
Smartphone app designed to teach cognitive defusion.
Intervention Type
Behavioral
Intervention Name(s)
Self-Help App
Primary Outcome Measure Information:
Title
Change from Baseline in Social Anxiety Interaction Scale at 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.
Time Frame
Baseline and 7 days
Title
Change from Baseline in Social Phobia Scale at 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.
Time Frame
baseline and 7 days
Title
Change from Baseline in Cognitive Fusion Questionnaire at 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.
Time Frame
baseline and 7 days
Title
Change from Baseline in Believability of Anxious Feelings and Thoughts Questionnaire at 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.
Time Frame
baseline and 7 days
Title
Change from Baseline in Experiences Questionnaire at 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.
Time Frame
baseline and 7 days
Title
Change from Baseline in Brief Social Anxiety - Acceptance and Action Questionnaire at 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..
Time Frame
baseline and 7 days
Secondary Outcome Measure Information:
Title
Readiness Ruler
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).
Time Frame
baseline
Title
Credibility/Expectancy Questionnaire
Description
Self-reported app credibility. Participants indicate how credible the treatment app seems.
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: must be seeking help for shyness/social anxiety must own a smartphone Exclusion Criteria: none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meagan B MacKenzie, Ph.D.
Organizational Affiliation
Wilfrid Laurier University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wilfrid Laurier University
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3C5
Country
Canada

12. IPD Sharing Statement

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