SKY Versus WLC in PTSD

NCT02553252 | Withdrawn

• 1 other identifier: 106851
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with post traumatic stress disorder (PTSD) will be randomized to a 12-week intervention of Sudarshan Kriya Yoga Trauma Relief Program (SKY) or a wait list control (WLC) to assess the effects of this intervention on symptoms of PTSD, depression, anxiety, quality of life, autonomic symptoms, and blood inflammatory markers.

Conditions

Post Traumatic Stress Disorder

Keywords

post traumatic stress disorder (PTSD); Sudarshan Kriya Yoga (SKY)

Outcome Measures

Primary Outcomes (1)

• Reduction in PTSD symptoms as assessed by the clinician administered PCL-5 (Post Traumatic Stress Disorder Check List).

  The clinician administered PCL-5 (Post Traumatic Stress Disorder Check List). willl be used to assess a change in PTSD symptoms from baseline to weeks 4, 8, 12, and 24.

  Change from baseline to: 4 weeks, 8 weeks, 12 weeks, and 24 weeks

Secondary Outcomes (8)

• Reduction in depression symptoms as assessed by the clinician administered HAM-D 17 (Hamilton Depression Score).

  Change from baseline to: 4 weeks, 8 weeks, 12 weeks, and 24 weeks

• Reduction in anxiety symptoms as assessed by the HAM-A (Hamilton Anxiety Scale).

  Change from baseline to: 4 weeks, 8 weeks, 12 weeks, and 24 weeks

• Improvement in autonomic parameters including heart rate variability and heart rate as assessed by a Bluetooth enabled Polar H7 Heart Rate Sensor.

  Change from baseline to: 12 weeks, and 24 weeks.

• Improvement in blood inflammatory markers as measured by enzyme-linked immunosorbent assay.

  Change from baseline to: 12 weeks, and 24 weeks.

• Reduction in depression symptoms using self-rated BDI 21 (Beck's Depression Inventory).

  Change from baseline to: 4 weeks, 8 weeks, 12 weeks, and 24 weeks

Study Arms (2)

Sudarshan Kriya Yoga Trauma Relief Program (SKY)

EXPERIMENTAL

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

Other: Sudarshan Kriya Yoga Trauma Relief Program (SKY)

wait list control (WLC)

NO INTERVENTION

Participants will receive training in SKY after 12 weeks have passed since the baseline assessment.

Interventions

Sudarshan Kriya Yoga Trauma Relief Program (SKY) OTHER

Participants in the SKY group will undergo a 12-week training course in Sudarshan Kriya Yoga (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:

• Have an Axis 1 diagnosis of PTSD as per CAPS5 (Clinician Administered PTSD Scale for DSM 5- past month version) criteria.
• If participants are using antidepressants, 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 other similar studies.
• 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, Neurocognitive disorder, Obsessive Compulsive 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: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 5, 2015
• First Posted: September 17, 2015
• Study Start: November 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: March 8, 2018

Record last verified: 2018-03

Locations

CA (1)