Social Anxiety DisorderNCT02266680
Breathing Focused Yoga in Social Anxiety Disorder
A study testing Yoga Treatment Group in people with Social Anxiety Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
The goal of this study is to determine the safety and effectiveness of Breathing Focused Yoga (BFY) in improving symptoms of social anxiety disorder (SAD). Patients with SAD will be randomized to 8 weeks of yoga or 8 weeks of wait-list. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- Yoga Treatment Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2012to 30 Jan 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged 18-65 years
- Primary diagnosis of SAD, per the DSM-IV-TR (APA, 2000)
- LSAS score of ≥50
- Absence of serious medical illness
- Not on any psychotropic medications currently, or on stable medications for at least 8 weeks prior to starting treatment
- Short-acting benzodiazepines (e.g. lorazepam 1 mg prn) and sleep medications (e.g. zopiclone 7.5 mg prn) may be used, but not within 12 hours prior to a study visit
Who cannot join
- Current primary diagnosis of major depressive episode, mania or psychosis
- A score of ≥15 on the first 17 items of the HAM-D at Screening or Baseline
- Diagnosis of a substance abuse disorder within the prior 6 months
- Presence of medical or mental health conditions that would inhibit the patient's ability to participate in the study
- Currently receiving any structured formal psychotherapy (supportive therapy is allowed)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of the Effectiveness of Breathing Focused Yoga (BFY) in Improving Symptoms of Social Anxiety Disorder
The goal of this study is to determine the safety and effectiveness of Breathing Focused Yoga (BFY) in improving symptoms of social anxiety disorder (SAD). Patients with SAD will be randomized to 8 weeks of yoga or 8 weeks of wait-list. Symptom severity and quality of life will be compared between the two groups before and after the 8 weeks.
Read the detailed description
This is an exploratory 8-week study with a randomized controlled, parallel group design, and will be carried out in two phases: 1) 8-week treatment phase and 2) a 3-month follow-up phase.
60 patients meeting Diagnostic and Statistical Manual IV Text Revision, (DSM-IV-TR), diagnostic criteria for social anxiety disorder will be recruited. Patients who have provided written consent, have met study criteria, and are stabilized on pharmacotherapy will be enrolled into the study.
In the treatment phase, patients will be randomized, to one of two groups 1) Breathing Focused Yoga (BFY); or 2) wait-list group.
A sub-set of 15 drug- naïve patients and matched healthy controls will undergo functional magnetic resonance imaging (fMRI) scans before and after yoga treatment.
A blood sample for genetic analysis will be taken from all SAD patients, to investigate to presence of genes linked to SAD and t treatment response.
The primary aim of the study is to determine the safety and effectiveness of Breathing Focused Yoga (BFY) in improving symptoms of SAD.
There are two secondary aims:
- To enhance the limited research data on the effect of treatment on neural circuitry in SAD, the investigators will also conduct fMRI scans on SAD patients and matched healthy controls pre- and post-BFY intervention.
- As well, to add to the literature on the genetics of SAD, the investigators will validate the links between specific gene polymorphisms and SAD that are already identified in the literature, and evaluate if they predict treatment response following BFY intervention.
Primary Hypotheses
- Subjects with Social Anxiety Disorder will show significant improvement in symptoms after BFY, compared to the wait-list group.
- Improvement in quality of life scores will be significantly greater in the BFY group compared to the wait-list group.
Secondary Hypotheses
- At baseline, the fMRI indications of neural circuitry of SAD subjects will differ from that of healthy controls.
- After yoga treatment, the fMRI indications of neural circuitry of treatment responders in the SAD group will be similar to that of healthy controls.
- The presence of specific gene polymorphisms in SAD patients will predict treatment response.
- Conditions
- Social Anxiety Disorder
- Being tested
- Yoga Treatment Group
- Keywords
- Social Anxiety, Yoga
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga Treatment GroupBehavioural
Also called Breathing Focused Yoga
The breathing focused yoga intervention is a manualized yoga protocol developed at CAMH by the Mood and Anxiety Disorders group, with yoga teacher, Ms. Tiffany Garfinkel, as the lead. BFY incorporates postures and meditation, but there is a special focus on controlled breathing at different rates, including Ujjaji or slow inhalation, exhalation and holding of breath; Bhastrika or Kapalabhati, two types of vigorous breathing with forced exhalation; and cyclical breathing or a repeated pattern of slow, moderate and fast breathing.
| Study group | Role | What they receive |
|---|---|---|
| Yoga Treatment Group | Experimental | BFY will be taught by a trained yoga instructor. Group sessions will be offered twice a week for 60 minutes each (i.e., a total of 2 hours per week), for 8 weeks. Receives: Behavioral: Yoga Treatment Group |
| Waitlist Group | No intervention | Waitlisted participants will receive BFY at the next available group after their waitlist period is completed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Liebowitz Social Anxiety Scale (LSAS) Total Score
Measured: Baseline to study endpoint (Week 8)
Secondary outcomes (4)
Change in Clinical Global Impression Scale
Measured: Baseline to study endpoint (Week 8)
Change in Hamilton Depression Rating Scale (HAM-D) Total Score
Measured: Baseline to study endpoint (Week 8)
Change in Quality of Life Enjoyment and Satisfaction Scale (QLESQ) Total Score
Measured: Baseline to study endpoint (Week 8)
Change in Quick Inventory of Depressive Symptomatology (QIDS) Total Score
Measured: Baseline to study endpoint (Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startJan 2012
- Primary completionJan 2017
- Study completion30 Jan 2017
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.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arun Ravindran, Centre for Addiction and Mental Health
- Investigators
- Arun Ravindran, MD, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02266680
- Sponsor's protocol ID
- 150/2011
- Status last verified
- Sep 2016
- First submitted
- 7 Oct 2014
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Effectiveness of Breathing Focused Yoga (BFY) in Improving Symptoms of Social Anxiety Disorder
- ClinicalTrials.gov ID
- NCT02266680
- Acronym / sponsor ID
- 150/2011
- Conditions
- Social Anxiety Disorder
- Keywords
- Social Anxiety, Yoga
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2017 (actual)
- Study completion
- 30 Jan 2017 (actual)
- First posted
- 17 Oct 2014 (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 goal of this study is to determine the safety and effectiveness of Breathing Focused Yoga (BFY) in improving symptoms of social anxiety disorder (SAD). Patients with SAD will be randomized to 8 weeks of yoga or 8 weeks of wait-list. Symptom severity and quality of life will be compared between the two groups before and after the 8 weeks.
Detailed description
This is an exploratory 8-week study with a randomized controlled, parallel group design, and will be carried out in two phases: 1) 8-week treatment phase and 2) a 3-month follow-up phase.
60 patients meeting Diagnostic and Statistical Manual IV Text Revision, (DSM-IV-TR), diagnostic criteria for social anxiety disorder will be recruited. Patients who have provided written consent, have met study criteria, and are stabilized on pharmacotherapy will be enrolled into the study.
In the treatment phase, patients will be randomized, to one of two groups 1) Breathing Focused Yoga (BFY); or 2) wait-list group.
A sub-set of 15 drug- naïve patients and matched healthy controls will undergo functional magnetic resonance imaging (fMRI) scans before and after yoga treatment.
A blood sample for genetic analysis will be taken from all SAD patients, to investigate to presence of genes linked to SAD and t treatment response.
The primary aim of the study is to determine the safety and effectiveness of Breathing Focused Yoga (BFY) in improving symptoms of SAD.
There are two secondary aims:
- To enhance the limited research data on the effect of treatment on neural circuitry in SAD, the investigators will also conduct fMRI scans on SAD patients and matched healthy controls pre- and post-BFY intervention.
- As well, to add to the literature on the genetics of SAD, the investigators will validate the links between specific gene polymorphisms and SAD that are already identified in the literature, and evaluate if they predict treatment response following BFY intervention.
Primary Hypotheses
- Subjects with Social Anxiety Disorder will show significant improvement in symptoms after BFY, compared to the wait-list group.
- Improvement in quality of life scores will be significantly greater in the BFY group compared to the wait-list group.
Secondary Hypotheses
- At baseline, the fMRI indications of neural circuitry of SAD subjects will differ from that of healthy controls.
- After yoga treatment, the fMRI indications of neural circuitry of treatment responders in the SAD group will be similar to that of healthy controls.
- The presence of specific gene polymorphisms in SAD patients will predict treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga Treatment Group | Experimental | Behavioral: Yoga Treatment GroupBFY will be taught by a trained yoga instructor. Group sessions will be offered twice a week for 60 minutes each (i.e., a total of 2 hours per week), for 8 weeks. |
| Waitlist Group | No intervention | –Waitlisted participants will receive BFY at the next available group after their waitlist period is completed |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients aged 18-65 years
- Primary diagnosis of SAD, per the DSM-IV-TR (APA, 2000)
- LSAS score of ≥50
- Absence of serious medical illness
- Not on any psychotropic medications currently, or on stable medications for at least 8 weeks prior to starting treatment
Key exclusion criteria (5 listed)
- Current primary diagnosis of major depressive episode, mania or psychosis
- A score of ≥15 on the first 17 items of the HAM-D at Screening or Baseline
- Diagnosis of a substance abuse disorder within the prior 6 months
- Presence of medical or mental health conditions that would inhibit the patient's ability to participate in the study
- Currently receiving any structured formal psychotherapy (supportive therapy is allowed)
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 |
|---|---|---|
| Yoga Treatment GroupAlso: Breathing Focused YogaThe breathing focused yoga intervention is a manualized yoga protocol developed at CAMH by the Mood and Anxiety Disorders group, with yoga teacher, Ms. Tiffany Garfinkel, as the lead. BFY incorporates postures and meditation, but there is a special focus on controlled breathing at different rates, including Ujjaji or slow inhalation, exhalation and holding of breath; Bhastrika or Kapalabhati, two types of vigorous breathing with forced exhalation; and cyclical breathing or a repeated pattern of slow, moderate and fast breathing. | Behavioural | Yoga Treatment Group |
Primary outcome
Change in Liebowitz Social Anxiety Scale (LSAS) Total Score
Time frame: Baseline to study endpoint (Week 8)
4 secondary outcomes
Change in Clinical Global Impression Scale
Time frame: Baseline to study endpoint (Week 8)
Change in Hamilton Depression Rating Scale (HAM-D) Total Score
Time frame: Baseline to study endpoint (Week 8)
Change in Quality of Life Enjoyment and Satisfaction Scale (QLESQ) Total Score
Time frame: Baseline to study endpoint (Week 8)
Change in Quick Inventory of Depressive Symptomatology (QIDS) Total Score
Time frame: Baseline to study endpoint (Week 8)
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 19 Jul 2017.
- Information about research at the Centre for Addiction and Mental HealthLink provided by the sponsor.
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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.
Arun Ravindran, MD, PhD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga Treatment Group in people with Social Anxiety Disorder, run by Centre for Addiction and Mental Health 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 6 inclusion and 5 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 19 Jul 2017. 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 in Liebowitz Social Anxiety Scale (LSAS) Total Score (time frame: Baseline to study endpoint (Week 8)). 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 19 Jul 2017.