Post Traumatic Stress DisorderNCT02749253
Sudarshan Kriya Yoga (SKY) in Post Traumatic Stress Disorder: a Feasibility Study
A study testing Sudarshan Kriya Yoga Tauma 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
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. 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 Tauma Relief Program (SKY).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2016to Aug 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
- 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
Who cannot join
- 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.
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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
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.
Read the detailed description
This is a single-center, open-label,longitudinal, empirical, feasibility trial of a 12 week intervention of Sudarshan Kriya Yoga in patients with Post traumatic stress disorder.
Research participants will be men and women, 18-75 years of age, who have a confirmed diagnosis of PTSD. Recruitment will occur 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 a clinically diagnosed PTSD by a psychiatrist and any other co-morbid diagnoses would have been previously confirmed by the physician. 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 presence of current suicidality. If the total score on Questions C1 and C2 is more than 5 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 significant cognitive impairment
A 12-week intervention of Sudarshan Kriya Yoga will be conducted, as per the details provided below. The SKY PTSD program is a mind-body resilience building program which has been specifically developed for persons with PTSD by the investigators collaborating not for profit organisation, Art of Living Foundation. The investigators wish to assess the feasibility of this intervention in the investigators routine trauma clinic at LHSC. The prescribed program of SKY includes specific breathing exercises, interactive discussions, journaling, yoga and guided meditations. It is supposed that the workshop builds a framework for resilience and empowerment, and develops self-awareness, connectedness and community, and a positive outlook. This minimally invasive treatment is not routinely performed as part of standard of care and is being applied in the study population for research purposes only. In addition to using feasibility measures, the investigators will use well-established clinical scales to assess symptoms of PSTD as well as comorbid depression, anxiety, quality of life as well as physiological measurements of the heart. These specifically include heart rate variability (HRV) and blood pressure measured at baseline (week 0), week 12 and week 24. Additionally, the investigators shall collect blood samples to measure possible changes in blood inflammatory markers at these three intervals of the study as described below.
Sudarshan Kriya Yoga (SKY): Participants will continue to receive their treatment as usual, including pharmacotherapy and/or psychotherapy. Following the initial clinical screening measurements, participants will undergo a 12-week training course conducted by certified instructors from the Art of Living Foundation who will be supervised by one of the study co-investigators (RN). There will be two instructors for this study (one male Spenser Delisle and one female Hiteshini Jugessur) for the initial 6 day course; both are certified as Art of Living instructors of SKY, in addition to being certified to work with traumatized populations. They have had experience of teaching more than 2000 people in multiple settings. Additional certified instructors may conduct follow up sessions. There will always be an overlap between the existing instructor and a replacement instructor, to ensure comfort of study participants. SKY training will take place in group-format (group sizes of 8-15 participants) in an appropriately sized and accessible community hall in London, Ontario. Given that men and women tend to have different sources of trauma, separate groups will be held for each gender. This is in accordance with current practices used in the Trauma Program at LHSC. While the investigators do not anticipate gender differences, the investigators have decided to stratify this study by gender to allow participants in these groups to feel more safe and comfortable, which is key to maximizing benefits of the course. 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). Nutritional snacks will be provided during the 6 session SKY training course. Information regarding demographic data, past psychiatric history, current ongoing psychological interventions, current medications, smoking and substance use status and any comorbid medical illnesses will be collected at baseline. Any change in status of ongoing psychological interventions, medications, smoking, alcohol and substance use, medical illnesses will be noted at each assessment visit in addition to hospitalizations or ER visits. This information is important to control for confounding factors as well as for risk assessment. The weight and height of patients will be measured at baseline and weight will be measured at each assessment visit to monitor for any effect of SKY yoga on weight (positive or negative). The information will be asked from the patient and/ or collected from the clinical charts if patient is distressed about giving the information, particularly past psychiatric history including trauma. Any adverse effects related to SKY will be monitored using a structured questionnaire, at each assessment visit (week 4, 8, 12 and 24).
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Sudarshan Kriya Yoga Tauma 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 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
| 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 Tauma Relief Program (SKY). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startJun 2016
- Primary completionAug 2017
- Study completionAug 2017
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 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
- NCT02749253
- Sponsor's protocol ID
- 107728
- Status last verified
- Aug 2017
- First submitted
- 6 Mar 2016
- Last updated
- 24 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sudarshan Kriya Yoga (SKY) in Post Traumatic Stress Disorder: a Feasibility Study
- ClinicalTrials.gov ID
- NCT02749253
- Acronym / sponsor ID
- 107728
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- Post Traumatic Stress Disorder (PTSD), Sudarshan Kriya Yoga (SKY)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 22 Apr 2016 (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.
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.
Detailed description
This is a single-center, open-label,longitudinal, empirical, feasibility trial of a 12 week intervention of Sudarshan Kriya Yoga in patients with Post traumatic stress disorder.
Research participants will be men and women, 18-75 years of age, who have a confirmed diagnosis of PTSD. Recruitment will occur 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 a clinically diagnosed PTSD by a psychiatrist and any other co-morbid diagnoses would have been previously confirmed by the physician. 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 presence of current suicidality. If the total score on Questions C1 and C2 is more than 5 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 significant cognitive impairment
A 12-week intervention of Sudarshan Kriya Yoga will be conducted, as per the details provided below. The SKY PTSD program is a mind-body resilience building program which has been specifically developed for persons with PTSD by the investigators collaborating not for profit organisation, Art of Living Foundation. The investigators wish to assess the feasibility of this intervention in the investigators routine trauma clinic at LHSC. The prescribed program of SKY includes specific breathing exercises, interactive discussions, journaling, yoga and guided meditations. It is supposed that the workshop builds a framework for resilience and empowerment, and develops self-awareness, connectedness and community, and a positive outlook. This minimally invasive treatment is not routinely performed as part of standard of care and is being applied in the study population for research purposes only. In addition to using feasibility measures, the investigators will use well-established clinical scales to assess symptoms of PSTD as well as comorbid depression, anxiety, quality of life as well as physiological measurements of the heart. These specifically include heart rate variability (HRV) and blood pressure measured at baseline (week 0), week 12 and week 24. Additionally, the investigators shall collect blood samples to measure possible changes in blood inflammatory markers at these three intervals of the study as described below.
Sudarshan Kriya Yoga (SKY): Participants will continue to receive their treatment as usual, including pharmacotherapy and/or psychotherapy. Following the initial clinical screening measurements, participants will undergo a 12-week training course conducted by certified instructors from the Art of Living Foundation who will be supervised by one of the study co-investigators (RN). There will be two instructors for this study (one male Spenser Delisle and one female Hiteshini Jugessur) for the initial 6 day course; both are certified as Art of Living instructors of SKY, in addition to being certified to work with traumatized populations. They have had experience of teaching more than 2000 people in multiple settings. Additional certified instructors may conduct follow up sessions. There will always be an overlap between the existing instructor and a replacement instructor, to ensure comfort of study participants. SKY training will take place in group-format (group sizes of 8-15 participants) in an appropriately sized and accessible community hall in London, Ontario. Given that men and women tend to have different sources of trauma, separate groups will be held for each gender. This is in accordance with current practices used in the Trauma Program at LHSC. While the investigators do not anticipate gender differences, the investigators have decided to stratify this study by gender to allow participants in these groups to feel more safe and comfortable, which is key to maximizing benefits of the course. 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). Nutritional snacks will be provided during the 6 session SKY training course. Information regarding demographic data, past psychiatric history, current ongoing psychological interventions, current medications, smoking and substance use status and any comorbid medical illnesses will be collected at baseline. Any change in status of ongoing psychological interventions, medications, smoking, alcohol and substance use, medical illnesses will be noted at each assessment visit in addition to hospitalizations or ER visits. This information is important to control for confounding factors as well as for risk assessment. The weight and height of patients will be measured at baseline and weight will be measured at each assessment visit to monitor for any effect of SKY yoga on weight (positive or negative). The information will be asked from the patient and/ or collected from the clinical charts if patient is distressed about giving the information, particularly past psychiatric history including trauma. Any adverse effects related to SKY will be monitored using a structured questionnaire, at each assessment visit (week 4, 8, 12 and 24).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sudarshan Kriya Yoga Trauma Relief Program (SKY) | Experimental | Other: Sudarshan Kriya Yoga Tauma Relief Program (SKY).Participants will receive training in SKY soon after completing baseline assessments. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
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 Tauma Relief Program (SKY).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 | Other | Sudarshan Kriya Yoga Trauma Relief Program (SKY) |
Primary outcome
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.
Time frame: 2 years
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.
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.
Time frame: 2 years
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.
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.
Time frame: 2 years
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.
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.
Time frame: 2 years
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.
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.
Time frame: 2 years
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.
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.
Time frame: 2 years
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.
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.
Time frame: 2 years
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.
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.
Time frame: 2 years
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.
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.
Time frame: 2 years
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.
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.
Time frame: 2 years
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.
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.
Time frame: 2 years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
- Individual participant dataSharing planned: No
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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 Tauma 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: finished, as of the sponsor's last update on 24 Aug 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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. (time frame: 2 years). The study lists 11 primary outcomes in all. 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 24 Aug 2017.