SKY vs. HEP in PTSD

NCT03534583 | Terminated Phase 2

• 1 other identifier: 111756
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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

PTSD

Outcome Measures

Primary Outcomes (1)

• Change in Post traumatic stress disorder check list (PCL-5)

  The PCL-5 is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms. Participants will be asked to rate how bothered they have been by each item in the past month on a 5-point Likert scale ranging from 0-4. Items are summed to provide a total score ranging from 0 to 80, with higher scores indicating more severe symptoms of PTSD.

  Change from baseline to weeks 4, 8, 12 and 26.

Secondary Outcomes (14)

• Change in Hamilton Depression Scale (HAMD-17)

  Change from baseline to weeks 4, 8, 12 and 26.

• Change in Beck's Depression Inventory (BDI)

  Change from baseline to weeks 4, 8, 12 and 26

• Change in Hamilton Anxiety Scale (HAM-A)

  Change from baseline to weeks 4, 8, 12 and 26.

• Change in Toronto Side Effects Scale (TSES)

  Change from baseline to weeks 4, 8, 12 and 26

• Change in World Health Organization Quality of Life Scale (WHOQOL-Bref)

  Change from baseline ato weeks 4, 8, 12 and 26

Study Arms (2)

Health Enhancement Program (HEP)

ACTIVE COMPARATOR

The Health-Enhancement Program (HEP) is structurally equivalent to a SKY intervention, with similar-sized groups, meeting for 3 consecutive days for 1.5-3 hours. There will then be a a gap of 4 days where participants will practice what they have learned, followed by 3 consecutive days of 1.5-3 hours of instruction. Starting the following week participants will attend once weekly follow up sessions (60-90 min/wk) for 3 weeks and then bimonthly sessions for the next 8 weeks. Participants will be asked to complete 25 min/day of course homework. Participants will learn about health promotion, healthy diet, music, and exercise, but do not learn breathing techniques, or meditation. In HEP, which has been manualized, participants get the support of a group and facilitator, and talk through and try to implement positive health-enhancing life changes, HEP will be delivered by a trained social worker (or equivalent).

Other: Health Enhancement Program

Sudarshan Kriya Yoga (SKY)

EXPERIMENTAL

The SKY PTSD program is a mind-body resilience building program developed for persons with PTSD. Through SKY breathing, interactive discussions, journaling, yoga and guided meditations, the workshop builds a framework for resilience and empowerment, and develops self-awareness, connectedness and community, and a positive outlook. SKY training will take place in group-format (6-8 participants). During the first week participants will attend three 2.5-3 hour sessions on three consecutive days. There will then be a gap of 4 days where participants can apply the tools provided, followed by three more consecutive days of 1.5-3 hours of instruction. This will be followed by once weekly follow up sessions (90 min/wk) for 3 weeks and then bimonthly sessions (every 2 weeks) for the next 8 weeks. In addition, participants will be asked to practice SKY at home daily (25 min/day) throughout the duration of the study period (up to 26 weeks) and log practice frequency.

Other: Sudarshan Kriya Yoga

Interventions

Sudarshan Kriya Yoga OTHER

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

Also known as: SKY

Sudarshan Kriya Yoga (SKY)

Health Enhancement Program OTHER

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.

Also known as: HEP

Health Enhancement Program (HEP)

Eligibility Criteria

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

You may qualify if:

• Between the age of 18 and 75.
• Has confirmed Axis 1 diagnosis of PTSD as per CAPS5
• Sufficiently able to hear allowing them to follow verbal instructions. Able to communicate sufficiently in English.
• 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.
• Access to a device with a camera and microphone, internet access, and a private space large enough to accommodate a yoga mat (a yoga mat is not required a comfortable floor space or blanket can be substituted).

You may not qualify if:

• Currently participating in other studies on PTSD treatment.
• Score severe or extreme on Depersonalization (item 29) or Derealization (item 30) of CAPS5.
• Have other significant mental health diagnosis including bipolar disorder, Schizophrenia, Neurocognitive disorder, and/or severe Personality Disorder (confirmed by Psychiatrist and MINI).
• Have significant substance dependence, or for those that have significant substance use disorder (have been regularly using within 6 weeks prior to commencement of intervention) or are unable to attend the intervention and assessment sessions while not under the influence of a substance.
• Have a risk of suicide as elicited by clinical interview (MINI).
• Have psychotic episodes within the past 12 months.
• Have a 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.
• Non-professionals with complex PTSD. Professionals include those who have served in the Canadian armed forces, are public safety personnel or are health care professionals.
• Currently practice any type of formal meditation, mindfulness or breathing techniques regularly.
• Have serious cardiovascular disease in the past 12 months (i.e.myocardial infarction, stroke, uncontrolled hypertension or TIA), or a past history of neurological disease (including Parkinson's Disease), seizures, or diabetic neuropathy.
• Major surgery within 8 weeks prior to commencement of the intervention, or a scheduled major surgery during the intervention period.
• Have mental health difficulties that has prevented participant from leaving the house, and/or missed appointments in last 3 months.
• Have vacation plans that will interfere with participant's ability to participate in the study.

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: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Raters, investigators and physicians will not be aware of participant treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 29, 2018
• First Posted: May 23, 2018
• Study Start: August 1, 2018
• Primary Completion: May 29, 2022
• Study Completion: May 29, 2022
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)