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SKY vs. HEP in PTSD

NCT03534583 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2022-06-01

No results posted yet for this study

Summary

Post-traumatic stress disorder (PTSD) is the third most common mental illness with a lifetime prevalence rate of 9.2% in Canada. Depression and anxiety are common comorbidities making treatment complex. Currently available treatments for PTSD include medications and talk therapies. However, their best combined response rates are around 50%. Our recent pilot feasibility study showed potential benefits of a breathing based meditation intervention called Sudarshan Kriya Yoga (SKY) in PTSD, as an augmentation treatment. The investigators seek to now assess the safety and efficacy of SKY intervention compared to an active control, Health Enhancement Program (HEP) in a double blind randomized controlled trial. The investigators will include PTSD patients with a wide range of trauma experience including road traffic accidents, childhood, physical, emotional or sexual abuse, or recurrent traumas over the lifespan. Patients will be offered a 12-week program of either SKY or HEP interventions as an add-on to their existing treatment schedules. This study will examine if patients with PTSD experience a reduction in PTSD symptoms from baseline to 12-week follow-up, as measured by the PCL-5 after receiving either HEP or SKY.

Conditions

Interventions

OTHER

Sudarshan Kriya Yoga

Participants in the SKY group will undergo an oline 12-week training course conducted by certified teachers of the Art of Living Foundation

OTHER

Health Enhancement Program

Participants in the online HEP will learn about health promotion, healthy diet, music, and exercise, but will not learn breathing techniques, or meditation. HEP will be delivered by trained staff.

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2022-05-29
Completion
2022-05-29

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03534583 on ClinicalTrials.gov