NCT02265211

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 15, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 16, 2015

Status Verified

June 1, 2015

Enrollment Period

6 months

First QC Date

October 6, 2014

Last Update Submit

June 15, 2015

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Secondary Outcomes (2)

  • Readiness Ruler

    baseline

  • Credibility/Expectancy Questionnaire

    baseline

Study Arms (1)

Self-Help App

EXPERIMENTAL

Smartphone app designed to teach cognitive defusion.

Behavioral: Self-Help App

Interventions

Self-Help AppBEHAVIORAL
Self-Help App

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wilfrid Laurier University

Waterloo, Ontario, N2L 3C5, Canada

Location

MeSH Terms

Conditions

Anxiety DisordersShyness

Condition Hierarchy (Ancestors)

Mental DisordersSocial BehaviorBehavior

Study Officials

  • Meagan B MacKenzie, Ph.D.

    Wilfrid Laurier University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Fellow

Study Record Dates

First Submitted

October 6, 2014

First Posted

October 15, 2014

Study Start

October 1, 2014

Primary Completion

April 1, 2015

Study Completion

June 1, 2015

Last Updated

June 16, 2015

Record last verified: 2015-06

Locations