Sudarshan Kriya Yoga (SKY) in Post Traumatic Stress Disorder: a Feasibility Study

NCT02749253 | Completed

• 1 other identifier: 107728
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study is designed to investigate the feasibility of sudarshan kriya yoga (SKY) program in adults with post traumatic stress disorder (PTSD) resulting from a wide range of trauma experience. SKY incorporates standardized collection of breathing techniques which are known to positively influence the autonomic nervous system and stress response system. Both these systems are dysregulated in PTSD.

Conditions

Post Traumatic Stress Disorder

Keywords

Post Traumatic Stress Disorder (PTSD); Sudarshan Kriya Yoga (SKY)

Outcome Measures

Primary Outcomes (11)

• Feasibility of conducting a larger RCT for Sudarshan Kriya Yoga Trauma Relief Program (SKY) in participants with Post Traumatic Stress Disorder (PTSD) considering the number of potential participants approached.

  The number of potential participants with PTSD who are approached for potential study participation will be recorded. This information will be used to assess if a larger SKY study for participants with PTSD is likely to be successful.

  2 years

• Feasibility of conducting a larger RCT for Sudarshan Kriya Yoga Trauma Relief Program (SKY) in participants with Post Traumatic Stress Disorder (PTSD) considering the proportion of participants successfully screened.

  The proportion of successfully screened participants with PTSD will be recorded. This information will be used to assess if a larger SKY study for participants with PTSD is likely to be successful.

  2 years

• Feasibility of conducting a larger RCT for Sudarshan Kriya Yoga Trauma Relief Program (SKY) in participants with Post Traumatic Stress Disorder (PTSD) considering the proportion of screened participants who enroll.

  The proportion of screened participants with PTSD who enroll will be recorded. This information will be used to assess if a larger SKY study for participants with PTSD is likely to be successful.

  2 years

• Feasibility of conducting a larger RCT for Sudarshan Kriya Yoga Trauma Relief Program (SKY) in participants with Post Traumatic Stress Disorder (PTSD) considering the retention rate of the study.

  The proportion of participants enrolled in the study who complete the study intervention and assessments will be assessed. This information will be used to assess if a larger SKY study for participants with PTSD is likely to be successful.

  2 years

• Feasibility of conducting a larger RCT for Sudarshan Kriya Yoga Trauma Relief Program (SKY) in participants with Post Traumatic Stress Disorder (PTSD) considering the rate of adherence to study protocol.

  Participant intervention attendance and assessment attendance will be recorded to determine if participants are willing to adhere to the study protocol. This information will be used to assess if a larger SKY study for participants with PTSD is likely to be successful.

  2 years

• Feasibility of conducting a larger RCT for Sudarshan Kriya Yoga Trauma Relief Program (SKY) in participants with Post Traumatic Stress Disorder (PTSD) considering the proportion of completed planned ratings.

  The proportion of completed planned ratings will be calculated. This information will be used to assess if a larger SKY study for participants with PTSD is likely to be successful.

  2 years

• Feasibility of conducting a larger RCT for Sudarshan Kriya Yoga Trauma Relief Program (SKY) in participants with Post Traumatic Stress Disorder (PTSD) considering the intervention cost per case.

  The intervention cost per study participant will be calculated. This information will be used to assess if a larger SKY study for participants with PTSD is financially feasible.

  2 years

• Feasibility of conducting a larger RCT for Sudarshan Kriya Yoga Trauma Relief Program (SKY) in participants with Post Traumatic Stress Disorder (PTSD) considering the completeness of final data for analysis.

  The completeness of final data for analysis will be assessed. The proportion of incomplete Case Report Forms and Questionnaires will be calculated. This information will be used to assess if a larger SKY study for participants with PTSD is likely to be successful.

  2 years

• Feasibility of conducting a larger RCT for Sudarshan Kriya Yoga Trauma Relief Program (SKY) in participants with Post Traumatic Stress Disorder (PTSD) considering the length of time to collect all data.

  The length of time to collect all data will be recorded, including the time required for each assessment, and the time required to enter data into a database. The proportion of incomplete Case Report Forms and Questionnaires will be calculated. This information will be used to assess if a larger SKY study for participants with PTSD is likely to be successful.

  2 years

• Feasibility of conducting a larger RCT for SKY in participants with PTSD considering any capacity issues with partners providing intervention and investigators being able to perform the tasks that they are committed to doing.

  Any capacity issues with the partners providing intervention and investigators being able to perform the tasks that they are committed to doing will be recorded. This information will be used to assess if a larger SKY study for participants with PTSD is likely to be successful.

  2 years

• Feasibility of conducting a larger RCT for SKY in participants with Post Traumatic Stress Disorder (PTSD) considering if it is safe to apply the intervention in this population as assessed by a SKY adverse effects questionnaire.

  A SKY adverse effects questionnaire will be used at baseline, week 4, week 8, and week 12 to assess if the SKY intervention is safe to use in this population. This information will be assessed at two years and used to determine if a larger SKY study for participants with PTSD is likely to be successful.

  2 years

Study Arms (1)

Sudarshan Kriya Yoga Trauma Relief Program (SKY)

EXPERIMENTAL

Participants will receive training in SKY soon after completing baseline assessments.

Other: Sudarshan Kriya Yoga Tauma Relief Program (SKY).

Interventions

Sudarshan Kriya Yoga Tauma Relief Program (SKY). OTHER

Sudarshan Kriya Yoga Trauma Relief Program (SKY) participants will undergo a 12-week training course in SKY conducted by certified instructors from the Art of Living Foundation

Sudarshan Kriya Yoga Trauma Relief Program (SKY)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of PTSD as per CAPS5 (Clinician Administered PTSD Scale for DSM 5- past month version) criteria.
• If participants are using antidepressants or antipsychotics used as mood augmenting agents, they must be at therapeutic doses for a minimum of four weeks prior to commencing the study. Patients who are not willing to take any medications will also be eligible for the study
• Sufficient hearing to be able to follow verbal instructions and able to sit without physical discomfort for 60 minutes.
• Willing and able to attend 6 initial SKY training sessions and 75% of follow up sessions
• Not pregnant and willing to remain not pregnant for the duration of the study

You may not qualify if:

• They are currently participating in a similar study on either a pharmacological or non-pharmacological intervention for treatment of their PTSD.
• If the patient scores severe or extreme on Depersonalization (item 29) or Derealization (item 30) items of CAPS5.
• Other significant mental health diagnosis including substance dependence, Major Neurocognitive disorder, Panic Disorder, Bipolar disorder and/or Personality disorder (confirmed by Psychiatrist and MINI)
• High risk of suicide as elicited by clinical interview (MINI).
• Psychotic episodes within the past 12 months.
• Traumatic Brain Injury (TBI) as defined by loss of consciousness for more than 20 minutes and/or Glasgow Coma Scale score less than or equal to 12. The researcher will use self-reported histories to screen for traumatic brain injury and if necessary confirmed by medical records.
• Currently practicing any type of formal meditation, mindfulness or breathing techniques regularly.
• Serious cardiovascular disease in the past 12 months (i.e. myocardial infarction, stroke, TIA, uncontrolled hypertension), or a past history of neurological disease (including Parkinson's Disease), seizures, or diabetic neuropathy
• Major surgery within 6 weeks prior to commencement of the intervention, or a scheduled major surgery during the intervention period. (This is due to the physical rigor of the breathing techniques)

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

Victoria Hospital, LHSC

London, Ontario, N6A 5W9, Canada

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Kamini Vasudev

Study Record Dates

• First Submitted: March 6, 2016
• First Posted: April 22, 2016
• Study Start: June 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: August 24, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)