Self-help for Treating Social Anxiety Disorder: An Evaluation of a Mindfulness and Acceptance-based Approach
Primary Purpose
Anxiety, Shyness
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
The Mindfulness and Acceptance-based Workbook for Social Anxiety and Shyness (Fleming & Kocovski, 2013)
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety
Eligibility Criteria
Inclusion Criteria:
- must be seeking help for shyness/social anxiety
Exclusion Criteria:
-
Sites / Locations
- Wilfrid Laurier University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Workbook
Control
Arm Description
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).
Waitlist control
Outcomes
Primary Outcome Measures
Change from Baseline to 4 and 8 weeks later in The Liebowitz Social Anxiety Scale (Liebowitz, 1987)
Self-reported social anxiety scores. Each item is scored 0 (none) to 3 (severe) yielding a total between 0 and 72.
Change from Baseline to 4 and 8 weeks later in the Freiberg Mindfulness Inventory (Buchheld, Grossman, & Walach, 2001)
Self-reported mindfulness. Each item is scored 0 (rarely) to 4 (almost always) yielding a total between and 0 and 56.
Change from Baseline to 4 and 8 weeks later in the Social Anxiety - Acceptance and Action Questionnaire (MacKenzie & Kocovski, 2010)
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.
Change from Baseline to 4 and 8 weeks later in the Beck Depression Inventory (Beck, Steer, & Brown, 1996)
Self-reported depression symptoms. Each item is scored 0 to 3 yielding a total between and 0 and 63.
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).
This 6-item scale assesses the participants' idea of treatment credibility.
Secondary Outcome Measures
Full Information
NCT ID
NCT02400918
First Posted
March 23, 2015
Last Updated
November 23, 2016
Sponsor
Wilfrid Laurier University
1. Study Identification
Unique Protocol Identification Number
NCT02400918
Brief Title
Self-help for Treating Social Anxiety Disorder: An Evaluation of a Mindfulness and Acceptance-based Approach
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wilfrid Laurier University
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Shyness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Workbook
Arm Type
Experimental
Arm Description
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).
Arm Title
Control
Arm Type
No Intervention
Arm Description
Waitlist control
Intervention Type
Other
Intervention Name(s)
The Mindfulness and Acceptance-based Workbook for Social Anxiety and Shyness (Fleming & Kocovski, 2013)
Intervention Description
An acceptance and commitment therapy-based self-help workbook for social anxiety and shyness. It includes an 8-week program.
Primary Outcome Measure Information:
Title
Change from Baseline to 4 and 8 weeks later in The Liebowitz Social Anxiety Scale (Liebowitz, 1987)
Description
Self-reported social anxiety scores. Each item is scored 0 (none) to 3 (severe) yielding a total between 0 and 72.
Time Frame
Baseline and 4 weeks and 8 weeks
Title
Change from Baseline to 4 and 8 weeks later in the Freiberg Mindfulness Inventory (Buchheld, Grossman, & Walach, 2001)
Description
Self-reported mindfulness. Each item is scored 0 (rarely) to 4 (almost always) yielding a total between and 0 and 56.
Time Frame
Baseline and 4 weeks and 8 weeks
Title
Change from Baseline to 4 and 8 weeks later in the Social Anxiety - Acceptance and Action Questionnaire (MacKenzie & Kocovski, 2010)
Description
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.
Time Frame
Baseline and 4 weeks and 8 weeks
Title
Change from Baseline to 4 and 8 weeks later in the Beck Depression Inventory (Beck, Steer, & Brown, 1996)
Description
Self-reported depression symptoms. Each item is scored 0 to 3 yielding a total between and 0 and 63.
Time Frame
Baseline and 4 weeks and 8 weeks
Title
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).
Description
This 6-item scale assesses the participants' idea of treatment credibility.
Time Frame
One week following the start of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
must be seeking help for shyness/social anxiety
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy L Kocovski, PhD
Organizational Affiliation
Wilfrid Laurier University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wilfrid Laurier University
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L3C5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Self-help for Treating Social Anxiety Disorder: An Evaluation of a Mindfulness and Acceptance-based Approach
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