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

• ClinicalTrials.gov Identifier: NCT02265211
• Recruitment Status: Completed
• First Posted: October 15, 2014
• Last Update Posted: June 16, 2015
• Sponsor: Wilfrid Laurier University
• Information provided by (Responsible Party): Meagan MacKenzie, Wilfrid Laurier University

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.

Condition or disease	Intervention/treatment	Phase
Anxiety; Shyness	Behavioral: Self-Help App	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Mindfulness and Acceptance-Based Treatments for Social Anxiety: Defusion App
• Study Start Date: October 2014
• Actual Primary Completion Date: April 2015
• Actual Study Completion Date: June 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Self-Help App; Smartphone app designed to teach cognitive defusion.	Behavioral: Self-Help App

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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..

Secondary Outcome Measures :

1. 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).
2. Credibility/Expectancy Questionnaire [ Time Frame: baseline ]
   Self-reported app credibility. Participants indicate how credible the treatment app seems.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• none

Contacts and Locations

Locations

Canada, Ontario

Wilfrid Laurier University

Waterloo, Ontario, Canada, N2L 3C5

Sponsors and Collaborators

Wilfrid Laurier University

Investigators

• Principal Investigator: Meagan B MacKenzie, Ph.D.; Wilfrid Laurier University

More Information

• Responsible Party: Meagan MacKenzie, Postdoctoral Fellow, Wilfrid Laurier University
• ClinicalTrials.gov Identifier: NCT02265211
• Other Study ID Numbers: 4207
• First Posted: October 15, 2014
• Last Update Posted: June 16, 2015
• Last Verified: June 2015

Additional relevant MeSH terms:

Anxiety Disorders; Mental Disorders