Breathing Focused Yoga in Social Anxiety Disorder

NCT02266680 | Completed DMC

• 1 other identifier: 150/2011
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Anxiety Disorder

Keywords

Social Anxiety; Yoga

Outcome Measures

Primary Outcomes (1)

• Change in Liebowitz Social Anxiety Scale (LSAS) Total Score

  Baseline to study endpoint (Week 8)

Secondary Outcomes (4)

• Change in Clinical Global Impression Scale

  Baseline to study endpoint (Week 8)

• Change in Hamilton Depression Rating Scale (HAM-D) Total Score

  Baseline to study endpoint (Week 8)

• Change in Quality of Life Enjoyment and Satisfaction Scale (QLESQ) Total Score

  Baseline to study endpoint (Week 8)

• Change in Quick Inventory of Depressive Symptomatology (QIDS) Total Score

  Baseline to study endpoint (Week 8)

Study Arms (2)

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.

Behavioral: Yoga Treatment Group

Waitlist Group

NO INTERVENTION

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

Interventions

Yoga Treatment Group BEHAVIORAL

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.

Also known as: Breathing Focused Yoga

Yoga Treatment Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addition and Mental Health

Toronto, Ontario, M6J 1H4, Canada

Location

Related Links

• Information about research at the Centre for Addiction and Mental Health

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Arun Ravindran, MD, PhD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: October 17, 2014
• Study Start: January 1, 2012
• Primary Completion: January 1, 2017
• Study Completion: January 30, 2017
• Last Updated: July 19, 2017

Record last verified: 2016-09

Locations

CA (1)