- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02400918
Self-help for Treating Social Anxiety Disorder: An Evaluation of a Mindfulness and Acceptance-based Approach
November 23, 2016 updated by: Meagan MacKenzie, Wilfrid Laurier University
Social anxiety disorder (SAD) is the most common anxiety disorder, affecting up to 10% of the population and causing significant distress.
Fortunately, there are effective interventions including cognitive behavior therapy (CBT) and acceptance and commitment therapy (ACT).
However, only about a third of people with SAD seek treatment.
There are a number of barriers to seeking treatment, including cost, availability, and stigma.
Self-help may be one way to reach people who may not otherwise present for treatment.
Research on self-help books for SAD based on CBT has yielded promising results.
However, no research to date has examined the efficacy of ACT-based self-help for SAD.
The primary purpose of the present study is to evaluate The Mindfulness and Acceptance-based Workbook for Social Anxiety and Shyness (Fleming & Kocovski, 2013), an ACT-based self-help book.
Socially anxious participants will be randomly assigned to receive the workbook or be placed on a waitlist.
It is hypothesized that workbook participants will report significantly reduced social anxiety at the end of eight weeks compared to waitlist participants.
The secondary purpose is to evaluate how the treatment works.
Increases in mindfulness and acceptance have been shown to lead to reduced social anxiety.
These same variables will be examined in the present study.
Finally, this research aims to examine variables that can predict who may do well in treatment.
Given that two-thirds of people who meet criteria for this disorder will not seek traditional treatments, it is important to develop and evaluate alternative treatments, including those based on self-help.
Study Overview
Status
Completed
Study Type
Interventional
Enrollment (Actual)
170
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ontario
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Waterloo, Ontario, Canada, N2L3C5
- Wilfrid Laurier University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- must be seeking help for shyness/social anxiety
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Waitlist control
|
|
Experimental: Workbook
They will be directed to use the 8-week plan included in The Mindfulness and Acceptance-based Workbook for Social Anxiety and Shyness (Fleming & Kocovski, 2013), an ACT-based self-help book and to access mindfulness audio files located on the publisher's website (as described in the book).
|
An acceptance and commitment therapy-based self-help workbook for social anxiety and shyness.
It includes an 8-week program.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline to 4 and 8 weeks later in The Liebowitz Social Anxiety Scale (Liebowitz, 1987)
Time Frame: Baseline and 4 weeks and 8 weeks
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Self-reported social anxiety scores.
Each item is scored 0 (none) to 3 (severe) yielding a total between 0 and 72.
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Baseline and 4 weeks and 8 weeks
|
Change from Baseline to 4 and 8 weeks later in the Freiberg Mindfulness Inventory (Buchheld, Grossman, & Walach, 2001)
Time Frame: Baseline and 4 weeks and 8 weeks
|
Self-reported mindfulness.
Each item is scored 0 (rarely) to 4 (almost always) yielding a total between and 0 and 56.
|
Baseline and 4 weeks and 8 weeks
|
Change from Baseline to 4 and 8 weeks later in the Social Anxiety - Acceptance and Action Questionnaire (MacKenzie & Kocovski, 2010)
Time Frame: Baseline and 4 weeks and 8 weeks
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Self-reported acceptance of social anxiety symptoms.
Each item is scored 1 (never true) to 7 (always true) yielding a total between and 19 and 133.
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Baseline and 4 weeks and 8 weeks
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Change from Baseline to 4 and 8 weeks later in the Beck Depression Inventory (Beck, Steer, & Brown, 1996)
Time Frame: Baseline and 4 weeks and 8 weeks
|
Self-reported depression symptoms.
Each item is scored 0 to 3 yielding a total between and 0 and 63.
|
Baseline and 4 weeks and 8 weeks
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Treatment credibility will be assessed using the scale by Devilly and Borkovec (2000) one week following the start of treatment (consistent with Nordgreen et al., 2012).
Time Frame: One week following the start of treatment
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This 6-item scale assesses the participants' idea of treatment credibility.
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One week following the start of treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nancy L Kocovski, PhD, Wilfrid Laurier University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Actual)
September 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
March 23, 2015
First Submitted That Met QC Criteria
March 23, 2015
First Posted (Estimate)
March 27, 2015
Study Record Updates
Last Update Posted (Estimate)
November 25, 2016
Last Update Submitted That Met QC Criteria
November 23, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WilfridLU
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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