Social Anxiety DisorderNCT01914874
Efficacy of a Mindfulness Meditation Program for Social Anxiety Disorder
A study testing Mindfulness Meditation in people with Social Anxiety Disorder, run by Hopital Montfort at 1 site in Canada.
Trial summary
The aim of this study is to evaluate the feasibility and initial efficacy of an enhanced mindfulness-based program that includes "mindful exposure" to reduce anxiety and avoidance of social situations, and the Buddhist practice of self-compassion aimed at reducing harsh judgment and self-criticism that is… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- Mindfulness Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2013to Jan 2015
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary diagnosis of Social Anxiety Disorder; Baseline score of 30 or higher on the Liebowitz Social Anxiety Scale; Baseline score of 4 or higher on the Clinical Global Impression of Severity
Who cannot join
- Lifetime history of psychosis or bipolar disorder; substance abuse in the past 12 months; diagnosis of borderline or antisocial personality disorder; serious suicide risk; currently in psychotherapy; regular meditation or yoga practice in the past 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of an Enhanced Mindfulness-based Intervention for Social Anxiety Disorder: A Pilot Feasibility Randomized Controlled Trial
The aim of this study is to evaluate the feasibility and initial efficacy of an enhanced mindfulness-based program that includes "mindful exposure" to reduce anxiety and avoidance of social situations, and the Buddhist practice of self-compassion aimed at reducing harsh judgment and self-criticism that is characteristic of people with social anxiety disorder.
Read the detailed description
The purpose of this pilot study is to evaluate the feasibility and initial efficacy of an enhanced mindfulness-based intervention for SAD (MIND-SAD) that incorporates the following components: training in classical mindfulness, including concentration and insight (vipassana) meditation; training in self-compassion; and mindful exposure. An exploratory aim of the study is to evaluate the effects of the mindfulness intervention on biological markers of stress reactivity, including salivary cortisoland salivary alpha-amylase. The study is a two-arm, parallel design, prospective study comparing 12 weekly sessions of MIND-SAD delivered in a group format versus a wait-list control (WLC).
- Conditions
- Social Anxiety Disorder
- Being tested
- Mindfulness Meditation
- Keywords
- Community Sample
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness MeditationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Meditation | Experimental | 12 weekly sessions in group format Receives: Behavioral: Mindfulness Meditation |
| Wait-list | No intervention | Patients will receive the mindfulness intervention after a 12-week wait period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician-rated Liebowitz Social Phobia Scale
Measured: change from baseline at weeks 6, 12 and 3 months follow-up
Social Phobia Inventory
Measured: change from baseline at weeks 6, 12 and 3 months follow-up
Secondary outcomes (5)
Beck Depression Inventory
Measured: change from baseline at weeks 6, 12 and 3 months follow-up
Social Adjustment Scale-Self-Report
Measured: change from baseline at weeks 6 and 12 and 3 months follow-up
CGI-Severity of Illness
Measured: change from baseline at weeks 6, 12 and 3 months follow-up
Self-Compassion Scale
Measured: change from baseline at weeks 6, 12 and 3-months follow-up
Five Facet Mindfulness Questionnaire
Measured: change from baseline at weeks 6, 12 and 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Anxiety DisorderStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Montfort
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diana Koszycki, Hopital Montfort
- Investigators
- Diana Koszycki, PhD, Principal investigator, Montfort Hospital and University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914874
- Sponsor's protocol ID
- DK-05-02-13
- Status last verified
- Jun 2015
- First submitted
- 30 Jul 2013
- Last updated
- 1 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Enhanced Mindfulness-based Intervention for Social Anxiety Disorder: A Pilot Feasibility Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01914874
- Acronym / sponsor ID
- DK-05-02-13
- Conditions
- Social Anxiety Disorder
- Keywords
- Community Sample
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Hopital MontfortUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 2 Aug 2013 (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.
The aim of this study is to evaluate the feasibility and initial efficacy of an enhanced mindfulness-based program that includes "mindful exposure" to reduce anxiety and avoidance of social situations, and the Buddhist practice of self-compassion aimed at reducing harsh judgment and self-criticism that is characteristic of people with social anxiety disorder.
Detailed description
The purpose of this pilot study is to evaluate the feasibility and initial efficacy of an enhanced mindfulness-based intervention for SAD (MIND-SAD) that incorporates the following components: training in classical mindfulness, including concentration and insight (vipassana) meditation; training in self-compassion; and mindful exposure. An exploratory aim of the study is to evaluate the effects of the mindfulness intervention on biological markers of stress reactivity, including salivary cortisoland salivary alpha-amylase. The study is a two-arm, parallel design, prospective study comparing 12 weekly sessions of MIND-SAD delivered in a group format versus a wait-list control (WLC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Meditation | Experimental | Behavioral: Mindfulness Meditation12 weekly sessions in group format |
| Wait-list | No intervention | –Patients will receive the mindfulness intervention after a 12-week wait period |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary diagnosis of Social Anxiety Disorder; Baseline score of 30 or higher on the Liebowitz Social Anxiety Scale; Baseline score of 4 or higher on the Clinical Global Impression of Severity
Key exclusion criteria (1 listed)
- Lifetime history of psychosis or bipolar disorder; substance abuse in the past 12 months; diagnosis of borderline or antisocial personality disorder; serious suicide risk; currently in psychotherapy; regular meditation or yoga practice in the past 12 months
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 |
|---|---|---|
| Mindfulness Meditation | Behavioural | Mindfulness Meditation |
Primary outcome
Clinician-rated Liebowitz Social Phobia Scale
Time frame: change from baseline at weeks 6, 12 and 3 months follow-up
Social Phobia Inventory
Time frame: change from baseline at weeks 6, 12 and 3 months follow-up
5 secondary outcomes
Beck Depression Inventory
Time frame: change from baseline at weeks 6, 12 and 3 months follow-up
Social Adjustment Scale-Self-Report
Time frame: change from baseline at weeks 6 and 12 and 3 months follow-up
CGI-Severity of Illness
Time frame: change from baseline at weeks 6, 12 and 3 months follow-up
Self-Compassion Scale
Time frame: change from baseline at weeks 6, 12 and 3-months follow-up
Five Facet Mindfulness Questionnaire
Time frame: change from baseline at weeks 6, 12 and 3 months follow-up
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 1 Jul 2015.
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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.
Diana Koszycki, PhD principal investigator
Montfort Hospital and University of Ottawa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Meditation in people with Social Anxiety Disorder, run by Hopital Montfort 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 1 Jul 2015. 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?
Clinician-rated Liebowitz Social Phobia Scale (time frame: change from baseline at weeks 6, 12 and 3 months follow-up). The study lists 2 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 1 Jul 2015.