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Trial registered on ANZCTR


Registration number
ACTRN12618001467224
Ethics application status
Approved
Date submitted
21/08/2018
Date registered
31/08/2018
Date last updated
15/01/2019
Date data sharing statement initially provided
15/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study of individualised complex yoga for secondary traumatic stress in doctors-in-training
Scientific title
Controlled, pilot study of the effect of individualised complex yoga, compared to existing group yoga, on symptoms of secondary traumatic stress in doctors-in-training.
Secondary ID [1] 295866 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Secondary Traumatic Stress 309333 0
Burnout 309437 0
Compassion fatigue 309438 0
Condition category
Condition code
Mental Health 308197 308197 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants allocated to the individualised complex yoga intervention, will attend a 1-hour private yoga session with an experienced yoga facilitator once a week for eight (8) weeks at RPAH. They will also receive a 4-hour weekend retreat/intensive, eHealth home practice content and a voluntary FitBit® device. eHealth home practice will involve audio and video content delivered via smartphone. eHealth adherence will be tracked using smartphone activity data.

Participants in this study arm will also undertake 30-minutes of eHealth home practice per day, four (4) days per week, for a total average weekly dosage of 3.5 hours of yoga. In a cross-over design, participants allocated to the individualised complex yoga study arm first, will continue to the existing group yoga study arm for another eight (8) weeks. There will be no formal washout period.
Intervention code [1] 312201 0
Treatment: Other
Comparator / control treatment
Participants allocated to the existing group yoga arm, will attend a 1-hour group yoga session with an experienced yoga facilitator once a week for eight (8) weeks at RPAH. They will also receive eHealth home practice content and a voluntary FitBit® device. eHealth home practice will involve audio and video content delivered via smartphone. Participants in this study arm will undertake 30-minutes of eHealth home practice per day, five (5) days per week, for a total average weekly dosage of 3.5 hours of yoga. In a cross-over design, participants allocated to the existing group yoga study arm first, will continue to the individualised complex yoga study arm for another eight (8) weeks.

As a pilot study a minimum total of 20 participants will be targeted initially.
Control group
Active

Outcomes
Primary outcome [1] 307162 0
Secondary traumatic stress as measured by the Professional Quality of Life Scale (ProQOL)
Timepoint [1] 307162 0
This outcome will be measured at baseline, at eight weeks post-intervention commencement, and sixteen weeks post-intervention commencement (i.e. eight-weeks post-crossover).
Secondary outcome [1] 365703 0
Maslach's Burnout Inventory (MBI)
Timepoint [1] 365703 0
This outcome will be measured at baseline, at eight weeks post-intervention commencement, and sixteen weeks post-intervention commencement (i.e. eight-weeks post-crossover).
Secondary outcome [2] 365704 0
Physician Wellbeing Inventory (PWI)
Timepoint [2] 365704 0
This outcome will be measured at baseline, at eight weeks post-intervention commencement, and sixteen weeks post-intervention commencement (i.e. eight-weeks post-crossover).
Secondary outcome [3] 365705 0
Pittsburgh Sleep Quality Index (PSQI)
Timepoint [3] 365705 0
This outcome will be measured at baseline, at eight weeks post-intervention commencement, and sixteen weeks post-intervention commencement (i.e. eight-weeks post-crossover).
Secondary outcome [4] 365706 0
Five Facets of Mindfulness Questionnaire (FFMQ, Short Form 15-item)
Timepoint [4] 365706 0
This outcome will be measured at baseline, at eight weeks post-intervention commencement, and sixteen weeks post-intervention commencement (i.e. eight-weeks post-crossover).
Secondary outcome [5] 365707 0
Mindful Attention Awareness Scale (MAAS)
Timepoint [5] 365707 0
This outcome will be measured at baseline, at eight weeks post-intervention commencement, and sixteen weeks post-intervention commencement (i.e. eight-weeks post-crossover).
Secondary outcome [6] 365708 0
Life Events Check List for DSM-5 (LEC-5)
Timepoint [6] 365708 0
This outcome will be measured at baseline, at eight weeks post-intervention commencement, and sixteen weeks post-intervention commencement (i.e. eight-weeks post-crossover).
Secondary outcome [7] 365709 0
PTSD Check List for DSM-5 with Extended Criterion A (PCL-5)
Timepoint [7] 365709 0
This outcome will be measured at baseline, at eight weeks post-intervention commencement, and sixteen weeks post-intervention commencement (i.e. eight-weeks post-crossover).
Secondary outcome [8] 365710 0
Shutdown Dissociation Scale (SHUT-D)
Timepoint [8] 365710 0
This outcome will be measured at baseline, at eight weeks post-intervention commencement, and sixteen weeks post-intervention commencement (i.e. eight-weeks post-crossover).
Secondary outcome [9] 365711 0
Alcohol Use Disorders Identification Test (AUDIT-C)
Timepoint [9] 365711 0
This outcome will be measured at baseline, at eight weeks post-intervention commencement, and sixteen weeks post-intervention commencement (i.e. eight-weeks post-crossover).
Secondary outcome [10] 365712 0
Drug Use Disorders Identification Test (DUDIT)
Timepoint [10] 365712 0
This outcome will be measured at baseline, at eight weeks post-intervention commencement, and sixteen weeks post-intervention commencement (i.e. eight-weeks post-crossover).
Secondary outcome [11] 365713 0
Suicidal Ideation Attributes Scale (SIDAS)
Timepoint [11] 365713 0
This outcome will be measured at baseline, at eight weeks post-intervention commencement, and sixteen weeks post-intervention commencement (i.e. eight-weeks post-crossover).
Secondary outcome [12] 365714 0
Session adherence using attendance logs
Timepoint [12] 365714 0
This outcome will be measured at baseline, at eight weeks post-intervention commencement, and sixteen weeks post-intervention commencement (i.e. eight-weeks post-crossover).
Secondary outcome [13] 365715 0
Heart Rate via blood pressure monitor
Timepoint [13] 365715 0
This outcome will be measured at baseline, at eight weeks post-intervention commencement, and sixteen weeks post-intervention commencement (i.e. eight-weeks post-crossover).
Secondary outcome [14] 365716 0
Respiration Rate (RR) via manual visual assessment
Timepoint [14] 365716 0
This outcome will be measured at baseline, at eight weeks post-intervention commencement, and sixteen weeks post-intervention commencement (i.e. eight-weeks post-crossover).
Secondary outcome [15] 365717 0
Breath counting task via smartphone app Click Counter, video recorded and scored using visual assessment.
Timepoint [15] 365717 0
This outcome will be measured at baseline, at eight weeks post-intervention commencement, and sixteen weeks post-intervention commencement (i.e. eight-weeks post-crossover).
Secondary outcome [16] 365718 0
Heart Rate Variability (HRV) via finger PPG sensor Corsense and smartphone app Elite HRV
Timepoint [16] 365718 0
This outcome will be measured at baseline, at eight weeks post-intervention commencement, and sixteen weeks post-intervention commencement (i.e. eight-weeks post-crossover).
Secondary outcome [17] 365719 0
Body Mass Index (BMI): height using tape measure; and weight using standard scales.
Timepoint [17] 365719 0
This outcome will be measured at baseline, at eight weeks post-intervention commencement, and sixteen weeks post-intervention commencement (i.e. eight-weeks post-crossover).
Secondary outcome [18] 365720 0
Waist circumference using tape measure
Timepoint [18] 365720 0
This outcome will be measured at baseline, at eight weeks post-intervention commencement, and sixteen weeks post-intervention commencement (i.e. eight-weeks post-crossover).
Secondary outcome [19] 365721 0
Sitting-Rising Test (SRT)
Timepoint [19] 365721 0
This outcome will be measured at baseline, at eight weeks post-intervention commencement, and sixteen weeks post-intervention commencement (i.e. eight-weeks post-crossover).
Secondary outcome [20] 365722 0
Right shoulder flexion, extension, and abduction measured in degrees using Dr Goniometer app.
Timepoint [20] 365722 0
This outcome will be measured at baseline, at eight weeks post-intervention commencement, and sixteen weeks post-intervention commencement (i.e. eight-weeks post-crossover).
Secondary outcome [21] 365723 0
Right hip extension, flexion, abduction, and adduction measured in degrees using Dr Goniometer app.
Timepoint [21] 365723 0
This outcome will be measured at baseline, at eight weeks post-intervention commencement, and sixteen weeks post-intervention commencement (i.e. eight-weeks post-crossover).
Secondary outcome [22] 365724 0
Systolic and diastolic blood pressure using blood pressure monitor
Timepoint [22] 365724 0
This outcome will be measured at baseline, at eight weeks post-intervention commencement, and sixteen weeks post-intervention commencement (i.e. eight-weeks post-crossover).
Secondary outcome [23] 365725 0
Peripheral capillary oxygen saturation (SpO2) via standard blood pressure monitor
Timepoint [23] 365725 0
This outcome will be measured at baseline, at eight weeks post-intervention commencement, and sixteen weeks post-intervention commencement (i.e. eight-weeks post-crossover).
Secondary outcome [24] 365726 0
Knee flexion measured in degrees using Dr goniometer smartphone app
Timepoint [24] 365726 0
This outcome will be measured at baseline, at eight weeks post-intervention commencement, and sixteen weeks post-intervention commencement (i.e. eight-weeks post-crossover).
Secondary outcome [25] 365727 0
Thoracic spine extension and flexion measured in degrees using Dr Goniometer smartphone app
Timepoint [25] 365727 0
This outcome will be measured at baseline, at eight weeks post-intervention commencement, and sixteen weeks post-intervention commencement (i.e. eight-weeks post-crossover).
Secondary outcome [26] 365728 0
Spine flexion (forward bend) measured with tape measure in centimetres of fingertips from floor.
Timepoint [26] 365728 0
This outcome will be measured at baseline, at eight weeks post-intervention commencement, and sixteen weeks post-intervention commencement (i.e. eight-weeks post-crossover).
Secondary outcome [27] 365729 0
Cervical spine extension, flexion, lateral flexion, and rotation measured in degrees using Dr Goniometer smartphone app.
Timepoint [27] 365729 0
This outcome will be measured at baseline, at eight weeks post-intervention commencement, and sixteen weeks post-intervention commencement (i.e. eight-weeks post-crossover).
Secondary outcome [28] 365730 0
Left hip extension, flexion, abduction, and adduction measured in degrees using Dr Goniometer app.
Timepoint [28] 365730 0
This outcome will be measured at baseline, at eight weeks post-intervention commencement, and sixteen weeks post-intervention commencement (i.e. eight-weeks post-crossover).
Secondary outcome [29] 365731 0
Left shoulder flexion, extension, and abduction measured in degrees using Dr Goniometer app.
Timepoint [29] 365731 0
This outcome will be measured at baseline, at eight weeks post-intervention commencement, and sixteen weeks post-intervention commencement (i.e. eight-weeks post-crossover).

Eligibility
Key inclusion criteria
Participants must be currently employed as doctors-in-training at RPAH to be eligible.
Participants are still eligible with prior yoga experience.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants are excluded with serious cardio-respiratory disorders, including previous cardiac or respiratory failure, angina, and/or chronic dyspnoea.
Pregnancy is also excluded.

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)
Allocation will be on a convenience basis in consideration of the schedules of doctors-in-training and capacity of the yoga facilitator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No longer applicable.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Crossover
Other design features
As a psychophysiological intervention, blinding participants and facilitators is not possible. However, analysis will be blinded.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Biomarkers and self-report responses will be analysed using SAS. Fitabase® will be used for FitBit® device connection, deployment, data collection, and analysis support for data output. HRV measures will be captured using Elite HRV and validated in Kubios® if deemed necessary. Data analysis will be performed using de-identified data only.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11698 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 23778 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 300463 0
Hospital
Name [1] 300463 0
Royal Prince Alfred Hospital
Address [1] 300463 0
Professor Marie Bashir Centre
67-73 Missenden Road
Camperdown NSW 2050
Country [1] 300463 0
Australia
Funding source category [2] 300532 0
University
Name [2] 300532 0
University of Sydney
Address [2] 300532 0
Brain and Mind Centre
94 Mallett Street
Camperdown NSW 2050
Country [2] 300532 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Research Ethics and Governance Office (REGO)
RPAH,
Missenden Rd,
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 299932 0
University
Name [1] 299932 0
University of Sydney
Address [1] 299932 0
Brain and Mind Centre
Sydney Medical School
94 Mallett Street
Camperdown NSW 2050
Country [1] 299932 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301266 0
SLHD Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 301266 0
Research Ethics and Governance Office (REGO)
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 301266 0
Australia
Date submitted for ethics approval [1] 301266 0
03/09/2018
Approval date [1] 301266 0
15/10/2018
Ethics approval number [1] 301266 0
HREC/18/RPAH/511

Summary
Brief summary
The primary aim of this controlled, pilot study is to investigate the effect of an eight-week individualised, complex yoga intervention on symptoms of STS and burnout for doctors-in-training at RPAH. The study will compare an individualised, complex yoga intervention combined with eHealth and biofeedback, to: (i) existing group yoga who also receive eHealth and biofeedback; and ii) routine mentoring without yoga, eHealth, or biofeedback. eHealth and biofeedback are included as the intervention homework/home practice delivery mechanism. Mediators and mechanisms, such as mindfulness, emotional awareness, and interoception, will also be assessed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86422 0
Prof Nick Glozier
Address 86422 0
Office 6, Level 5
Professor Marie Bashir Centre
67-73 Missenden Rd
Camperdown NSW 2050
Country 86422 0
Australia
Phone 86422 0
+61295151596
Fax 86422 0
Email 86422 0
nick.glozier@sydney.edu.au
Contact person for public queries
Name 86423 0
Ms Jennifer Taylor
Address 86423 0
Office 8, Level 5
Professor Marie Bashir Centre
67-73 Missenden Rd
Camperdown NSW 2050
Country 86423 0
Australia
Phone 86423 0
+61295151461
Fax 86423 0
Email 86423 0
bmc.yoga-study@sydney.edu.au
Contact person for scientific queries
Name 86424 0
Ms Jennifer Taylor
Address 86424 0
Office 8, Level 5
Professor Marie Bashir Centre
67-73 Missenden Rd
Camperdown NSW 2050
Country 86424 0
Australia
Phone 86424 0
+61295151461
Fax 86424 0
Email 86424 0
jennifer.taylor1@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified quantitative data only will be available to protect participant privacy.
When will data be available (start and end dates)?
Immediately following publication with no end date determined
Available to whom?
Researchers who provide a methodologically sound proposal.
Available for what types of analyses?
Any appropriate purpose, including meta-analyses and systematic reviews
By what mechanism will data be made available?
Cloudstor
What supporting documents are/will be available?
Study protocol
Clinical study report
Ethical approval
Summary results
Not applicable