Self-help for Treating Social Anxiety Disorder: An Evaluation of a Mindfulness and Acceptance-based Approach

Anxiety Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02400918
• Other study ID #: WilfridLU
• Status: Completed
• Phase: N/A
• First received: March 23, 2015
• Last updated: November 23, 2016
• Start date: March 2015
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: Wilfrid Laurier University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• 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

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Shyness

Intervention

Other:
• The Mindfulness and Acceptance-based Workbook for Social Anxiety and Shyness (Fleming & Kocovski, 2013)
An acceptance and commitment therapy-based self-help workbook for social anxiety and shyness. It includes an 8-week program.

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 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.	Baseline and 4 weeks and 8 weeks	No
Primary	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.	Baseline and 4 weeks and 8 weeks	No
Primary	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.	Baseline and 4 weeks and 8 weeks	No
Primary	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.	Baseline and 4 weeks and 8 weeks	No
Primary	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.	One week following the start of treatment	No