What side effects are associated with this type of intervention?

Breathing techniques and meditation, such as those used in Sudarshan Kriya Yoga (v-SKY), are generally considered safe with minimal side effects. However, some individuals may experience temporary discomfort, such as increased anxiety, emotional distress, or physical discomfort during initial practice. These side effects are usually mild and tend to decrease with continued practice. It is important for individuals to practice these techniques under the guidance of a trained instructor to minimize any potential adverse effects.

What prior FDA approvals exist?

The FDA has approved several pharmacologic treatments for PTSD, including selective serotonin reuptake inhibitors (SSRIs) like sertraline and paroxetine. These medications help manage symptoms such as anxiety, depression, and sleep disturbances. Non-pharmacologic treatments, such as cognitive-behavioral therapy (CBT) and exposure therapy, are also widely used. While the FDA has not specifically approved breathing techniques and meditation for PTSD, these complementary therapies, including practices like Sudarshan Kriya Yoga (v-SKY), have shown promise in reducing PTSD symptoms in clinical studies. Further research is needed to establish their efficacy and potential for FDA approval.

What other types of research exist?

Promising alternatives to Sudarshan Kriya Yoga (v-SKY) for PTSD patients include: 1) Trauma-Informed Yoga, which has shown feasibility and preliminary efficacy in veterans with combat-related trauma. 2) Satyananda Yoga, which has been evaluated in a randomized controlled trial for reintegrating adults with PTSD. 3) Kripalu Yoga, which has demonstrated significant decreases in PTSD symptoms in military veterans and active duty personnel. These therapies incorporate both physical postures and mindfulness techniques, offering holistic approaches to managing PTSD symptoms.

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Sudarshan Kriya Yoga for PTSD

N/A

Recruiting

Led By Abhimanyu Sud, MD

Research Sponsored by Mount Sinai Hospital, Canada

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 18 years or older.

Meet criteria for current PTSD as determined by a score of >38 on the PTSD Checklist-5 (PCL-5).

Must not have

Seizure disorder not well controlled.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (week 0), follow-up 1 (week 6), follow-up 2 (week 12), follow-up 3 (week 30)

Awards & highlights

No Placebo-Only Group

Summary

This trial studies the effects of online yoga sessions on Canadian military and RCMP veterans with PTSD. The yoga involves breathing and relaxation exercises to help reduce stress and improve mental health. Researchers will compare the results to see if the yoga helps reduce PTSD symptoms and improve quality of life.

Who is the study for?

This trial is for Canadian military and RCMP veterans aged 18 or older with PTSD, as indicated by a PCL-5 score above 38. Participants must be able to consent, use Zoom, and not be involved in other trials or starting new behavioral therapies during the study.

What is being tested?

The trial tests virtual Sudarshan Kriya Yoga (v-SKY) against a waitlist control to see its effects on PTSD symptoms, depression, pain, anxiety, and life quality. It's an RCT that also examines how well v-SKY can be adopted and maintained among veterans.

What are the potential side effects?

Since SKY is a yoga-based intervention focusing on breathing techniques and meditation rather than medication or invasive procedures, significant side effects are not commonly reported. However, participants may experience discomfort or emotional distress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Select...

My PTSD score is above 38.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My seizures are not well controlled.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (week 0), follow-up 1 (week 6), follow-up 2 (week 12), follow-up 3 (week 30)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (week 0), follow-up 1 (week 6), follow-up 2 (week 12), follow-up 3 (week 30)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 0), follow-up 1 (week 6), follow-up 2 (week 12), follow-up 3 (week 30) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in PTSD symptoms

Other study objectives

Change in anxiety symptoms

Change in depressive symptoms

Change in pain symptoms

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Active intervention (ACT) groupExperimental Treatment1 Intervention

8-12 participants will meet for 3-hour sessions for the first 5 days of the intervention. This is followed by five weeks of 1-hour sessions twice per week. In total, the intervention will be 15 sessions that run for a total of 25 hours over 6-weeks. Experienced and licensed SKY instructors from the International Association for Human Values (IAHV) and Art of Living Foundation (AOLF) will provide the intervention through video calls. Instructors will guide participants through the v-SKY intervention through visual demonstrations and verbal guidance. All sessions will be delivered virtually using Zoom. Sessions will not be recorded.

Group II: Waitlist control (WLC) groupActive Control1 Intervention

8-12 participants will not receive the intervention for 6-weeks. The 6-weeks will line up with the v-SKY intervention that the ACT group receives. After the waitlist period, the WLC group will receive the same v-SKY intervention as the ACT group. According to our earlier estimates, a high number of veterans with PTSD may not be actively receiving treatment for their illness. For these reasons, a waitlist control design may better reflect the current treatment environment for veterans with PTSD.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for PTSD, such as breathing techniques, meditation, and mindfulness-based approaches, work by promoting relaxation and reducing arousal. These methods balance the autonomic nervous system by decreasing sympathetic activity (associated with the fight or flight response) and enhancing parasympathetic activity (associated with rest and digest). This balance is crucial for PTSD patients as it helps mitigate hyperarousal, anxiety, and intrusive thoughts, leading to improved sleep and overall quality of life.

Controlled Rhythmic Yogic Breathing as Complementary Treatment for Post-Traumatic Stress Disorder in Military Veterans: A Case Series.Effectiveness of an Extended Yoga Treatment for Women with Chronic Posttraumatic Stress Disorder.