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Breathing Focused Yoga in Social Anxiety Disorder

Primary Purpose

Social Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Yoga Treatment Group
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety Disorder focused on measuring Social Anxiety, Yoga

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female patients aged 18-65 years
  2. Primary diagnosis of SAD, per the DSM-IV-TR (APA, 2000)
  3. LSAS score of ≥50
  4. Absence of serious medical illness
  5. Not on any psychotropic medications currently, or on stable medications for at least 8 weeks prior to starting treatment
  6. 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

Exclusion Criteria:

  1. Current primary diagnosis of major depressive episode, mania or psychosis
  2. A score of ≥15 on the first 17 items of the HAM-D at Screening or Baseline
  3. Diagnosis of a substance abuse disorder within the prior 6 months
  4. Presence of medical or mental health conditions that would inhibit the patient's ability to participate in the study
  5. Currently receiving any structured formal psychotherapy (supportive therapy is allowed)

Sites / Locations

  • Centre for Addition and Mental Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Yoga Treatment Group

Waitlist Group

Arm Description

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.

Waitlisted participants will receive BFY at the next available group after their waitlist period is completed

Outcomes

Primary Outcome Measures

Change in Liebowitz Social Anxiety Scale (LSAS) Total Score

Secondary Outcome Measures

Change in Clinical Global Impression Scale
Change in Hamilton Depression Rating Scale (HAM-D) Total Score
Change in Quality of Life Enjoyment and Satisfaction Scale (QLESQ) Total Score
Change in Quick Inventory of Depressive Symptomatology (QIDS) Total Score

Full Information

First Posted
October 7, 2014
Last Updated
July 18, 2017
Sponsor
Centre for Addiction and Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT02266680
Brief Title
Breathing Focused Yoga in Social Anxiety Disorder
Official Title
A Randomized Controlled Trial of the Effectiveness of Breathing Focused Yoga (BFY) in Improving Symptoms of Social Anxiety Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder
Keywords
Social Anxiety, Yoga

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga Treatment Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist Group
Arm Type
No Intervention
Arm Description
Waitlisted participants will receive BFY at the next available group after their waitlist period is completed
Intervention Type
Behavioral
Intervention Name(s)
Yoga Treatment Group
Other Intervention Name(s)
Breathing Focused Yoga
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Liebowitz Social Anxiety Scale (LSAS) Total Score
Time Frame
Baseline to study endpoint (Week 8)
Secondary Outcome Measure Information:
Title
Change in Clinical Global Impression Scale
Time Frame
Baseline to study endpoint (Week 8)
Title
Change in Hamilton Depression Rating Scale (HAM-D) Total Score
Time Frame
Baseline to study endpoint (Week 8)
Title
Change in Quality of Life Enjoyment and Satisfaction Scale (QLESQ) Total Score
Time Frame
Baseline to study endpoint (Week 8)
Title
Change in Quick Inventory of Depressive Symptomatology (QIDS) Total Score
Time Frame
Baseline to study endpoint (Week 8)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arun Ravindran, MD, PhD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addition and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J 1H4
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.camh.net/research
Description
Information about research at the Centre for Addiction and Mental Health

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Breathing Focused Yoga in Social Anxiety Disorder

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