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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
170

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • Ontario
      • Waterloo, Ontario, Canada, N2L3C5
        • Wilfrid Laurier University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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
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
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
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
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
This 6-item scale assesses the participants' idea of treatment credibility.
One week following the start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wilfrid Laurier University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 25, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Conditions

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Drug Interventions

Dietary Supplements

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