Social Anxiety Disorder Clinical Trial
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.
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:
1. 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.
2. 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
1. Subjects with Social Anxiety Disorder will show significant improvement in symptoms
after BFY, compared to the wait-list group.
2. Improvement in quality of life scores will be significantly greater in the BFY group
compared to the wait-list group.
Secondary Hypotheses
1. At baseline, the fMRI indications of neural circuitry of SAD subjects will differ from
that of healthy controls.
2. After yoga treatment, the fMRI indications of neural circuitry of treatment responders
in the SAD group will be similar to that of healthy controls.
3. The presence of specific gene polymorphisms in SAD patients will predict treatment
response.
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