Comparing effects of Yoga and Relaxation therapies in patients with Anxiety disorder

Not Applicable

• Conditions: Health Condition 1: F41- Other anxiety disorders

• Registration Number: CTRI/2022/09/045780
• Lead Sponsor: ational Institute of Mental Health and Neurosciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

For patients:

1. Patients diagnosed with anxiety disorder except specific phobias and selective mutism as per ICD 11.

2. Patients with anxiety disorder who are on stable medications for at least 6 weeks.

3. Patients able to understand Hindi, English or Kannada language.

4. No history of alcohol or other substance dependence (except nicotine) in the last 6 months.

5. Between 18 to 60 years of age.

6. All genders.

For healthy controls:

1. Between 18 to 60 years of age.

2. All genders.

3. Able to understand Hindi, English or Kannada language.

4. No history of alcohol or other substance dependence (except nicotine) in the last 6 months.

5. No history of anxiety disorder or any other long term psychiatric illness.

Exclusion Criteria

For patients:

1. Patients having specific phobias like agoraphobia and patients with selective mutism.

2. Patients having contraindication to Trans-cranial magnetic stimulation (TMS). [check list- Trans-cranial magnetic stimulation adult safety screen (TASS)]

3. Co-morbid substance abuse (excluding nicotine dependence), psychosis, mood disorders, suicidal and self-injurious behavior and mental retardation.

4. Ongoing current practice of yoga or any other mind-body techniques (e.g.; meditation, Tai-Chi, or related practices) of more than 45 minutes per week on average within the last 6 months or total estimated cumulative prior lifetime practice for more than 100 hours.

5. Presence of co-morbid neurological or general medical disorder that can alter mood states as clinically assessed.

For healthy controls:

1. Presence of any psychiatric disorder as screened by PHQ-9 PRIME-MD (Patient Health Questionnaire) and assessed clinically.

2. Substance abuse (excluding nicotine dependence), psychosis, mood disorders, suicidal and self-injurious behavior and mental retardation.

3. Ongoing current practice of yoga or any other mind-body techniques (e.g.; meditation, Tai-Chi, or related practices) of more than 45 minutes per week on average within the last 6 months or total estimated cumulative prior lifetime practice for more than 100 hours.

4. Presence of neurological or general medical disorder that can alter mood states as clinically assessed.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Primary objective: To compare cortical inhibition parameters using Trans-cranial magnetic stimulation (TMS) between patients with anxiety disorder and Healthy controls. <br/ ><br> <br/ ><br>2.Secondary Objective: Study the effect of yoga on GABAergic system by measuring cortical inhibition in patients with anxiety disorder after 6 sessions of yoga or progressive muscular relaxation. <br/ ><br>Timepoint: The cortical inhibition parameters will be measured at baseline and again after the 6 sessions of Yoga or Progressive Muscular Relaxation (PMR).

Secondary Outcome Measures

Name	Time	Method
Comparison of anxiety scores between the groups before and after the intervention, using Hamilton Anxiety Rating Scale (HAM-A)Timepoint: Hamilton Anxiety Rating Scale (HAM-A) scores will be measured at baseline and again after 6 sessions of Yoga or Progressive Muscular Relaxation (PMR)