Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12622000936729p
Ethics application status
Submitted, not yet approved
Date submitted
14/06/2022
Date registered
30/06/2022
Date last updated
30/06/2022
Date data sharing statement initially provided
30/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A feasibility trial evaluating a yogic style of breathing (Sudarshan Kriya Yoga) in young people with anxiety and/or depression
Scientific title
A Feasibility Study Exploring the Benefits of Sudarshan Kriya Yoga in Young People with Symptoms of Anxiety or Depression (BREATHE)
Secondary ID [1] 307100 0
Nil Known
Universal Trial Number (UTN)
U1111-1279-3704
Trial acronym
BREATHE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 326257 0
Depression 326258 0
Condition category
Condition code
Mental Health 323565 323565 0 0
Anxiety
Mental Health 323953 323953 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The BREATHE study will investigate the use an adaptation of the Sudarshan Kriya Yoga Campus Happiness Program (SKY-CHP) in a single-arm block design for young people experiencing symptoms of anxiety and/or depression. This intervention model will be delivered over 1 month; this involves 3-days of group-based learning followed by 27-days of individual practice. The Sudarshan Kriya Yoga Campus Happiness Program comes from the non-profit organization called the Art Of Living (AOL) Foundation. Instructors for the BREATHE study will be graduates of the AOL teacher training program. Up to 10 young people will be allocated to each group and will be led by the instructor and an Orygen clinician over three days. These three sessions will be live interactive videoconferencing sessions where all participants will engage with the group, instructor, and clinician over the space of three hours. Participants will be asked to have a pen and paper available for notetaking throughout the program. Participation lasts for four weeks with participants to complete a training diary at the end of each week to determine levels of compliance. This diary will be sent to the participant via a REDCap link where they can select each day of the week corresponding to their practices. REDCap is a secure web platform for building and managing online databases and surveys. Attendance at SKY-CHP sessions will also be monitored.

During the 3-day SKY-CHP course you will learn the following:
Day 1:
Foundations of Wellbeing: Understanding the role of stress, breath, and Connectedness, and the Role of Breath and Meditation in Resilience. The facilitator will discuss the potential benefits of completing the course and participants will meet each other in small groups and introduce themselves. The facilitator will discuss the importance of connectedness and its relationship with overall wellness, mental wellbeing, resilience, stress management, and connecting with values. Following this, participants will be introduced to the eight ‘limbs’ of yoga- including Outward awareness, Inner awareness, Physical postures/stretching, Breathing techniques, Awareness/focusing of the 5 senses, Concentration of the mind, Contemplation, and Meditation. Participants share their experience with life stressors and highlight what they would like to learn in order to change or cope with these stressors and improve energy levels.

Participants will learn mental awareness techniques to bring the mind to the present, and a breathing technique to bring the mind to the present. They will also learn the role of breath in guiding the mind to the present moment. Participants will learn an advanced breathwork practice including the practice of 3-stage breathing, SKY, and light meditation.

Day 2: Developing wellbeing and Campus Happiness through connectedness and value-driven actions
Participants share what they have noticed since the previous session in relation to how their mind works (wandering /fusion /avoidance) and their experiences in using skills taught in the previous class. Furthermore, participants share their life values with one another and how each of these values can affect their own breath. They will discuss subjective happiness through the acceptance of the present moment, and cultivated through using the breath, meditation and present moment awareness. Participants are guided through an experiential practice in small groups, that increases awareness of the mind in the present moment, of the amount of effort required for effective action, and in-turn examines the relationship between the mind and effort. Finally, the facilitator discusses the value of truly listening to others, as it can focus our attention outwards rather than inwards and allows for cultivating greater compassion and empathy. The group will then finish with the practice of 3-stage breathing, SKY, and light meditation.

Day 3: Enhancing Connection, Mental Flexibility and Resilience
On day 3, in pairs, participants reflect on times in their own life when mistakes were handled well, and when they were handled poorly. The facilitator will guide a meditative process where participants observe internal experiences that come up with non-acceptance (fusion/avoidance), and those that come up with the mind when practicing acceptance. Participants will then share what it was like when they did something for someone that was consistent with their values, even in the presence of unwanted internal experiences.
Participants share experiences of mental flexibility that helped them overcome obstacles in life and the people and qualities they admire. In teams, participants review all the perspectives for coping with unwanted internal experiences and stressors that they learned in this course. The group will then finish with the practice of 3-stage breathing, SKY, and light meditation.

Day 15: Refresher Session
Participants will be invited to join an online session to refresh their memory of the SKY practice. With the instructor, participants will go through the practice in full and be able to ask any questions they have had since beginning their SKY practices.

INDIVIDUAL SKY PRACTICE:
Following the 3-Day SKY-CHP course, participants will continue to practice the learned techniques daily at home at a time that suits them for the following 27 days. Participants will perform the light physical yoga (5 minutes), the 3-stage breathing plus SKY breathing (10 minutes), and finish with meditation (5-10 minutes). The entire practice should take approximately 20 minutes.
Intervention code [1] 323551 0
Treatment: Other
Comparator / control treatment
There will not be a comparator group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331316 0
The feasibility of the BREATHE study will be assessed via a composite outcome. Feasibility will be assessed via recruitment and retention of completers of the adapted SKY-CHP intervention and BREATHE study visits. This will also be assessed with the number of blocks recruited over study period and recruitment and retention rate of participants within each block. These data will be determined by an audit of study enrolment logs, SKY-CHP attendance records, SKY compliance rates and records, and the study database,
Timepoint [1] 331316 0
Baseline, 15-Days, & 30-Days following intervention commencement
Primary outcome [2] 331317 0
Acceptability of the BREATHE study will be assessed via a composite outcome. Acceptability will be assessed via the participants experience of the intervention via a face-to-face in-depth qualitative interview. Acceptability ratings of the intervention will be completed via semi-structured interview including Intervention Appropriateness Measure (IAM) and Acceptability of Intervention Measure (AIM). This semi-structured interview will also assess participant’s expectations of the intervention and their perception of the intervention as a treatment therapy via Credibility and Expectancy Questionnaire (CEQ). Finally, intervention practice ratings will be measured via electronic practice diaries completed during the study period.
Timepoint [2] 331317 0
Baseline, 15-Days, & 30-Days following intervention commencement
Primary outcome [3] 331318 0
The safety of the intervention will be assessed based on a composite outcome. Safety will be assessed via the number and severity of adverse and serious adverse events during the trial collected at each study visit. The breathing practices involved may increase feelings of anxiety based on feedback provided to the study team via young people with lived-experience. Participants will be made aware of these potential effects and be asked to confer with the study clinician throughout training should they have any concerns. Any adverse effects will be added to our study adverse event log with details of duration, severity, and outcome.

Ongoing risk assessments will be carried out based on the Columbia Suicide Severity Rating Scale (C-SSRS).
Timepoint [3] 331318 0
Adverse events will be collected continuously from baseline to 30 days following intervention commencement.
Secondary outcome [1] 409508 0
Secondary aims to investigate changes in symptoms of depression via the Quick Inventory of Depressive Symptomatology (QIDS)
Timepoint [1] 409508 0
Baseline, 15-Days, & 30-Days following intervention commencement
Secondary outcome [2] 411010 0
Changes in anxiety via The Overall Anxiety Severity and Impairment Scale (OASIS)
Timepoint [2] 411010 0
Baseline, 15-Days, & 30-Days following intervention commencement
Secondary outcome [3] 411011 0
Changes in mindfulness via the Five Facet Mindfulness Questionnaire (FFMQ)
Timepoint [3] 411011 0
Baseline & 30-Days following intervention commencement
Secondary outcome [4] 411012 0
Changes in social connectedness via The Social Connectedness Scale Revised (SCS-R)
Timepoint [4] 411012 0
Baseline & 30-Days following intervention commencement
Secondary outcome [5] 411013 0
Changes in stress via The Perceived Stress Scale 10-Item Inventory (PSS-10)
Timepoint [5] 411013 0
Baseline & 30-Days following intervention commencement
Secondary outcome [6] 411014 0
Changes in well-being via The Ryff Scale of Psychological Well-being is an 18-item scale (RYFF)
Timepoint [6] 411014 0
Baseline & 30-Days following intervention commencement
Secondary outcome [7] 411015 0
Changes in depression, anxiety, and stress will be assessed via a composite outcome denoted the Depression, Anxiety, and Stress Scale (DASS-21)
Timepoint [7] 411015 0
Screening, 15-Days, & 30-Days following intervention commencement
Secondary outcome [8] 411016 0
Changes in quality of life via the Assessment of Quality of Life (AQoL-6D)
Timepoint [8] 411016 0
Baseline, 15-Days, & 30-Days following intervention commencement
Secondary outcome [9] 411017 0
Changes in functioning via the Social and Occupational Functioning Scale (SOFAS)
Timepoint [9] 411017 0
Baseline & 30-Days following intervention commencement
Secondary outcome [10] 411018 0
Changes in electrophysiological outcomes via resting state electroencephalography (EEG) & electrophsyiological markers including N200 & P300 event related potentials
Timepoint [10] 411018 0
Baseline & 30-Days following intervention commencement

Eligibility
Key inclusion criteria
• Aged 18 to 25 years
• Report mild symptoms or higher of anxiety (>3) or depression (>4) on the DASS-21
• Ability to provide informed consent
• Ability and willingness to nominate an emergency contact person, such as a close family member
• Ability and willingness to provide details of their clinician
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Has an uncontrolled or poorly managed respiratory condition that could interfere with breathing exercises
• Inability to converse in or read English. English does not have to be the young person’s primary language
• Has a diagnosis of bipolar disorder, post-traumatic stress disorder, or has current high risks (e.g., suicidal planning/intent)
• Has a history of or is currently experiencing psychosis due to contraindications of hyperventilation
Has a diagnosis of epilepsy due to contraindications of hyperventilation

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Quantitative measures investigating psychopathology will be analysed via linear mixed effects model with restricted maximum likelihood estimator. All models will include random intercepts for participants and fixed effects for time, age, and gender. Quantitative measures investigating acceptability and feasibility will be analysed via t-test midway through the study (Day 15) with pre- and post- comparisons for the CEQ assessment. All quantitative measures will be accompanied by effect size analysis and 95% confidence intervals. Descriptive statistics will calculate mean values and standard deviations for normally distributed data and medians with range or percentage for non-normal and categorical data. Descriptive analysis of adverse and serious adverse events will be examined, including estimation of any causal relationships they may have had with the intervention.
Qualitative interviews will be recorded and transcribed and analysed using Interpretive Phenomenological Analysis. This process will involve data familiarization, generation of initial codes, theme identification, refining of themes, and theme names.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 37796 0
3052 - Parkville
Recruitment postcode(s) [2] 37797 0
3064 - Craigieburn
Recruitment postcode(s) [3] 37798 0
3337 - Melton
Recruitment postcode(s) [4] 37799 0
3030 - Werribee
Recruitment postcode(s) [5] 37800 0
3046 - Glenroy
Recruitment postcode(s) [6] 37801 0
3020 - Sunshine

Funding & Sponsors
Funding source category [1] 311405 0
Charities/Societies/Foundations
Name [1] 311405 0
Hearts and Minds Investment Limited
Country [1] 311405 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Orygen
Address
Orygen
35 Poplar Road, Parkville, 3052, VIC
Country
Australia
Secondary sponsor category [1] 312794 0
None
Name [1] 312794 0
Address [1] 312794 0
Country [1] 312794 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310886 0
University of Melbourne Humanities, Arts and Social Sciences (HASS1) - Greater Than Low Risk (GTLR) committee
Ethics committee address [1] 310886 0
Ethics committee country [1] 310886 0
Australia
Date submitted for ethics approval [1] 310886 0
16/02/2022
Approval date [1] 310886 0
Ethics approval number [1] 310886 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119230 0
Dr Aswin Ratheesh
Address 119230 0
Orygen
35 Poplar Road, Parkville, VIC, 3052


Country 119230 0
Australia
Phone 119230 0
+61 0498 322 927
Fax 119230 0
Email 119230 0
[email protected]
Contact person for public queries
Name 119231 0
James D Kean
Address 119231 0
Orygen
35 Poplar Road, Parkville, VIC, 3052
Country 119231 0
Australia
Phone 119231 0
+61 425 735 847
Fax 119231 0
Email 119231 0
[email protected]
Contact person for scientific queries
Name 119232 0
James Kean
Address 119232 0
Orygen
35 Poplar Road, Parkville, VIC, 3052
Country 119232 0
Australia
Phone 119232 0
+61 425 735 847
Fax 119232 0
Email 119232 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Consent not available for IPD sharing.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15988Statistical analysis plan    384043-(Uploaded-14-06-2022-13-33-52)-Study-related document.docx
15989Informed consent form    384043-(Uploaded-14-06-2022-13-34-05)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.