AnxietyNCT02400918
Self-help for Treating Social Anxiety Disorder: An Evaluation of a Mindfulness and Acceptance-based Approach
A study testing The Mindfulness and Acceptance-based Workbook for Social Anxiety and Shyness (Fleming & Kocovski, 2013) in people with Anxiety and Shyness, run by Wilfrid Laurier University at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- The Mindfulness and Acceptance-based Workbook for Social Anxiety and Shyness (Fleming & Kocovski, 2013)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- must be seeking help for shyness/social anxiety
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- The Mindfulness and Acceptance-based Workbook for Social Anxiety and Shyness (Fleming & Kocovski, 2013)
- Medical subject headings
- Anxiety Disorders, Shyness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Mindfulness and Acceptance-based Workbook for Social Anxiety and Shyness (Fleming & Kocovski, 2013)Other
An acceptance and commitment therapy-based self-help workbook for social anxiety and shyness. It includes an 8-week program.
| Study group | Role | What they receive |
|---|---|---|
| Workbook | Experimental | 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). Receives: Other: The Mindfulness and Acceptance-based Workbook for Social Anxiety and Shyness (Fleming & Kocovski, 2013) |
| Control | No intervention | Waitlist control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Self-reported mindfulness. Each item is scored 0 (rarely) to 4 (almost always) yielding a total between and 0 and 56.
Measured: 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)
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.
Measured: 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)
Self-reported depression symptoms. Each item is scored 0 to 3 yielding a total between and 0 and 63.
Measured: 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).
This 6-item scale assesses the participants' idea of treatment credibility.
Measured: One week following the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wilfrid Laurier University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meagan MacKenzie, Wilfrid Laurier University
- Investigators
- Nancy L Kocovski, PhD, Principal investigator, Wilfrid Laurier University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400918
- Sponsor's protocol ID
- WilfridLU
- Status last verified
- Nov 2016
- First submitted
- 23 Mar 2015
- Last updated
- 25 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-help for Treating Social Anxiety Disorder: An Evaluation of a Mindfulness and Acceptance-based Approach
- ClinicalTrials.gov ID
- NCT02400918
- Acronym / sponsor ID
- WilfridLU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Wilfrid Laurier UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 27 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Workbook | Experimental | Other: The Mindfulness and Acceptance-based Workbook for Social Anxiety and Shyness (Fleming & Kocovski, 2013)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). |
| Control | No intervention | –Waitlist control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- must be seeking help for shyness/social anxiety
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Workbook |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy L Kocovski, PhD principal investigator
Wilfrid Laurier University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Mindfulness and Acceptance-based Workbook for Social Anxiety and Shyness (Fleming & Kocovski, 2013) in people with Anxiety and Shyness, run by Wilfrid Laurier University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2016.