- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02265211
Mindfulness and Acceptance-Based Treatments for Social Anxiety: Defusion App
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Waterloo, Ontario, Canada, N2L 3C5
- Wilfrid Laurier University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- must be seeking help for shyness/social anxiety
- must own a smartphone
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Self-Help App
Smartphone app designed to teach cognitive defusion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in Social Anxiety Interaction Scale at 7 days
Time Frame: Baseline and 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.
|
Baseline and 7 days
|
|
Change from Baseline in Social Phobia Scale at 7 days
Time Frame: baseline and 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.
|
baseline and 7 days
|
|
Change from Baseline in Cognitive Fusion Questionnaire at 7 days
Time Frame: baseline and 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.
|
baseline and 7 days
|
|
Change from Baseline in Believability of Anxious Feelings and Thoughts Questionnaire at 7 days
Time Frame: baseline and 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.
|
baseline and 7 days
|
|
Change from Baseline in Experiences Questionnaire at 7 days
Time Frame: baseline and 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.
|
baseline and 7 days
|
|
Change from Baseline in Brief Social Anxiety - Acceptance and Action Questionnaire at 7 days
Time Frame: baseline and 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..
|
baseline and 7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Readiness Ruler
Time Frame: baseline
|
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).
|
baseline
|
|
Credibility/Expectancy Questionnaire
Time Frame: baseline
|
Self-reported app credibility.
Participants indicate how credible the treatment app seems.
|
baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Meagan B MacKenzie, Ph.D., Wilfrid Laurier University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4207
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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