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Completed

NCT Number: NCT02265211

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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Mental Disorders Shyness Social Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wilfrid Laurier University

Waterloo, Ontario, N2L 3C5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

Self-Help App

Behavioral

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Wilfrid Laurier University

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 15, 2014
Registry last updated
Jun 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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