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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02265211
• Other study ID #: 4207
• Status: Completed
• Phase: N/A
• First received: October 6, 2014
• Last updated: June 15, 2015
• Start date: October 2014
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Wilfrid Laurier University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• must be seeking help for shyness/social anxiety

• must own a smartphone

Exclusion Criteria:

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Shyness

Intervention

Behavioral:
• Self-Help App

Locations

Country	Name	City	State
Canada	Wilfrid Laurier University	Waterloo	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Wilfrid Laurier University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 7 days	No
Primary	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.	baseline and 7 days	No
Primary	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.	baseline and 7 days	No
Primary	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.	baseline and 7 days	No
Primary	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.	baseline and 7 days	No
Primary	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..	baseline and 7 days	No
Secondary	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).	baseline	No
Secondary	Credibility/Expectancy Questionnaire	Self-reported app credibility. Participants indicate how credible the treatment app seems.	baseline	No