Post Traumatic Stress DisorderNCT02553252
SKY Versus WLC in PTSD
A study testing Sudarshan Kriya Yoga Trauma Relief Program (SKY) in people with Post Traumatic Stress Disorder, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Sudarshan Kriya Yoga Trauma Relief Program (SKY)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2015to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sudarshan Kriya Yoga (SKY) Versus Wait List Control (WLC) in Post Traumatic Stress Disorder: A Randomised Controlled Study
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.
Read the detailed description
A single-center, single blind longitudinal randomized controlled naturalistic trial comparing a 12 week Sudarshan Kriya Yoga Trauma Relief Program (SKY) intervention to a wait list control (WLC) group.
Research participants will be men and women, 18-75 years of age, who have PTSD. The study will recruit from the general adult ambulatory mental health clinics as well as the geriatric mental health program in London.
Potential participants will be screened as per inclusion and exclusion criteria by trained research staff. These patients will already have clinically diagnosed PTSD by a psychiatrist and any other comorbid diagnoses would have already been confirmed. However, for research purposes a diagnosis of PTSD will be confirmed through a structured clinical interview specifically the MINI (Mini International neuropsychiatric Interview) and the Clinician-administered PTSD Scale for DSM5- past month version (CAPS5). CAPS5 will also be used to rule out exclusion criteria of severe depersonalization and derealization. The scales will be administered by a trained research staff and confirmed by a psychiatrist.
The MINI will also be used to assess for suicidality. If the total score on Questions C1 and C2 is more than 5 at any time during the study then this will be reported to the PI who will further assess the patient for safety and risk assessment.
If the participant is above the age of 65 years of age they will also be asked to complete a cognitive screening test (Mini Mental State Examination, MMSE) to ensure they are not suffering from any memory impairments.
Participants who meet the inclusion criteria will be randomized to either SKY or WLC with equal probability (1:1) using computer generated randomisation numbers. Concealment of randomisation to outcome assessors and investigators will be ensured by an independent staff member who will perform the randomisation using a third party web based provider. Computerised randomization will take place in the Geriatric Mental Health Program outpatient unit in London Health Sciences, London, Ontario. A telephone number will be available for study concerns/queries. Pre-randomized information will be stored using unique de-identifiers and downloaded on a secure database. It will not be possible to blind participants to intervention status hence the single-blind design.
SKY training involves attending a week-long (6 days) course that teaches the basic principles of SKY over 2.5-3 hour daily sessions. 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 and log practice frequency and any other noteworthy observations in a log sheet that will be provided to them (please see attached log sheet). Meals will be provided for 2 days during the initial SKY training course and nutritional snacks on the other 4 days.
Participants randomized to the control arm of the study will continue to receive their treatment as usual, including pharmacotherapy and/or psychotherapy. They will follow assessment and study procedures as listed below. Upon completing the initial 12 weeks of the study, participants in the WLC arm will also be offered the opportunity to learn SKY and attend follow up therapy sessions; that is, WLC participants will be offered the same intervention as the SKY group received in the first 12 weeks of the study. No study procedures will be applied or any other information collected during this period except for a final assessment that will take place at 24 weeks (see below).
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Sudarshan Kriya Yoga Trauma Relief Program (SKY)
- Keywords
- post traumatic stress disorder (PTSD), Sudarshan Kriya Yoga (SKY)
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Sudarshan Kriya Yoga Trauma Relief Program (SKY) | Experimental | Participants will receive training in SKY soon after completing baseline assessments. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
A clinican administered depression severity assessment scale HAM-D 17 will be used to assess the change in depression symptoms from baseline to weeks 4, 8, 12, and 24.
Measured: 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).
A clinician administered Hamilton Anxiety Scale (HAM-A) will be used to assess a change in anxiety symptoms from baseline to weeks 4, 8, 12, and 24.
Measured: 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.
Heart rate and heart rate variability will be measured to assess a change from baseline to weeks 12 and 24 in autonomic parameters.
Measured: Change from baseline to: 12 weeks, and 24 weeks.
Improvement in blood inflammatory markers as measured by enzyme-linked immunosorbent assay.
A blood sample will be taken to run an enzyme-linked immunosorbent assay (ELISA) to assess levels of the following inflammatory markers: C-Reactive Protein (CRP), Interleukin-6 (IL-6), malondialdehyde (MDA) and total antioxidant capacity (including glutathione). This will be done at baseline, week 12, and week 24 to assess a change in blood inflammatory markers.
Measured: Change from baseline to: 12 weeks, and 24 weeks.
Reduction in depression symptoms using self-rated BDI 21 (Beck's Depression Inventory).
A self-administered depression severity assessment scale BDI 21 will be used to assess the change in depression symptoms from baseline to weeks 4, 8, 12, and 24.
Measured: Change from baseline to: 4 weeks, 8 weeks, 12 weeks, and 24 weeks
Change in quality of life as assessed by the WHOQOL-Bref (World Health Organization Quality of Life Scale).
The WHOQOL-Bref will be used to assess any changes in quality of life from baseline to weeks 4, 8, 12, and 24.
Measured: Change from baseline to: 4 weeks, 8 weeks, 12 weeks, and 24 weeks
Improvement in blood pressure as assessed by manually using a standard plethysmograph.
A research assistant will manually obtain 3 blood pressures at each blood pressure assessment. The mean will be calculate from the three measurements and used to assess a change in blood pressure from baseline to weeks 12 and weeks 24.
Measured: Change from baseline to: 12 weeks, and 24 weeks.
Improvement in the mean respiratory rate as measured manually.
The mean respiratory rate will be calculated from three readings taken at each of the respiratory rate assessments (baseline, week 12, and week 24). The research assistant will record the number of breaths per minute, each breath consisting of an inhalation and exhalation.
Measured: Change from baseline to: 12 weeks, and 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startNov 2015
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Why it stopped: A pilot study is currently in progress.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamini Vasudev, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02553252
- Sponsor's protocol ID
- 106851
- Status last verified
- Mar 2018
- First submitted
- 5 Sep 2015
- Last updated
- 8 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sudarshan Kriya Yoga (SKY) Versus Wait List Control (WLC) in Post Traumatic Stress Disorder: A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT02553252
- Acronym / sponsor ID
- 106851
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- post traumatic stress disorder (PTSD), Sudarshan Kriya Yoga (SKY)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: A pilot study is currently in progress.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 17 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A single-center, single blind longitudinal randomized controlled naturalistic trial comparing a 12 week Sudarshan Kriya Yoga Trauma Relief Program (SKY) intervention to a wait list control (WLC) group.
Research participants will be men and women, 18-75 years of age, who have PTSD. The study will recruit from the general adult ambulatory mental health clinics as well as the geriatric mental health program in London.
Potential participants will be screened as per inclusion and exclusion criteria by trained research staff. These patients will already have clinically diagnosed PTSD by a psychiatrist and any other comorbid diagnoses would have already been confirmed. However, for research purposes a diagnosis of PTSD will be confirmed through a structured clinical interview specifically the MINI (Mini International neuropsychiatric Interview) and the Clinician-administered PTSD Scale for DSM5- past month version (CAPS5). CAPS5 will also be used to rule out exclusion criteria of severe depersonalization and derealization. The scales will be administered by a trained research staff and confirmed by a psychiatrist.
The MINI will also be used to assess for suicidality. If the total score on Questions C1 and C2 is more than 5 at any time during the study then this will be reported to the PI who will further assess the patient for safety and risk assessment.
If the participant is above the age of 65 years of age they will also be asked to complete a cognitive screening test (Mini Mental State Examination, MMSE) to ensure they are not suffering from any memory impairments.
Participants who meet the inclusion criteria will be randomized to either SKY or WLC with equal probability (1:1) using computer generated randomisation numbers. Concealment of randomisation to outcome assessors and investigators will be ensured by an independent staff member who will perform the randomisation using a third party web based provider. Computerised randomization will take place in the Geriatric Mental Health Program outpatient unit in London Health Sciences, London, Ontario. A telephone number will be available for study concerns/queries. Pre-randomized information will be stored using unique de-identifiers and downloaded on a secure database. It will not be possible to blind participants to intervention status hence the single-blind design.
SKY training involves attending a week-long (6 days) course that teaches the basic principles of SKY over 2.5-3 hour daily sessions. 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 and log practice frequency and any other noteworthy observations in a log sheet that will be provided to them (please see attached log sheet). Meals will be provided for 2 days during the initial SKY training course and nutritional snacks on the other 4 days.
Participants randomized to the control arm of the study will continue to receive their treatment as usual, including pharmacotherapy and/or psychotherapy. They will follow assessment and study procedures as listed below. Upon completing the initial 12 weeks of the study, participants in the WLC arm will also be offered the opportunity to learn SKY and attend follow up therapy sessions; that is, WLC participants will be offered the same intervention as the SKY group received in the first 12 weeks of the study. No study procedures will be applied or any other information collected during this period except for a final assessment that will take place at 24 weeks (see below).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sudarshan Kriya Yoga Trauma Relief Program (SKY) | Experimental | Other: Sudarshan Kriya Yoga Trauma Relief Program (SKY)Participants will receive training in SKY soon after completing baseline assessments. |
| wait list control (WLC) | No intervention | –Participants will receive training in SKY after 12 weeks have passed since the baseline assessment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sudarshan Kriya Yoga Trauma Relief Program (SKY)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. | Other | Sudarshan Kriya Yoga Trauma Relief Program (SKY) |
Primary outcome
Reduction in PTSD symptoms as assessed by the clinician administered PCL-5 (Post Traumatic Stress Disorder Check List).
Time frame: Change from baseline to: 4 weeks, 8 weeks, 12 weeks, and 24 weeks
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.
8 secondary outcomes
Reduction in depression symptoms as assessed by the clinician administered HAM-D 17 (Hamilton Depression Score).
Time frame: 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).
Time frame: 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.
Time frame: Change from baseline to: 12 weeks, and 24 weeks.
Improvement in blood inflammatory markers as measured by enzyme-linked immunosorbent assay.
Time frame: Change from baseline to: 12 weeks, and 24 weeks.
Reduction in depression symptoms using self-rated BDI 21 (Beck's Depression Inventory).
Time frame: Change from baseline to: 4 weeks, 8 weeks, 12 weeks, and 24 weeks
Change in quality of life as assessed by the WHOQOL-Bref (World Health Organization Quality of Life Scale).
Time frame: Change from baseline to: 4 weeks, 8 weeks, 12 weeks, and 24 weeks
Improvement in blood pressure as assessed by manually using a standard plethysmograph.
Time frame: Change from baseline to: 12 weeks, and 24 weeks.
Improvement in the mean respiratory rate as measured manually.
Time frame: Change from baseline to: 12 weeks, and 24 weeks.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sudarshan Kriya Yoga Trauma Relief Program (SKY) in people with Post Traumatic Stress Disorder, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in PTSD symptoms as assessed by the clinician administered PCL-5 (Post Traumatic Stress Disorder Check List). (time frame: Change from baseline to: 4 weeks, 8 weeks, 12 weeks, and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2018.