Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000624785
Ethics application status
Approved
Date submitted
21/04/2022
Date registered
28/04/2022
Date last updated
21/07/2024
Date data sharing statement initially provided
28/04/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Yoga or cognitive behavioural therapy for psychological distress and emotional difficulties: Can our neurophysiology predict treatment efficacy?
Scientific title
Transdiagnostic treatments for emotional resilience: Efficacy and mechanisms of yoga versus cognitive behavioural therapy
Secondary ID [1] 306981 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
At least subclinical mental health 326096 0
Condition category
Condition code
Mental Health 323407 323407 0 0
Anxiety
Mental Health 323408 323408 0 0
Depression
Mental Health 323409 323409 0 0
Addiction
Mental Health 323410 323410 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
YOGA

Yoga – a holistic practice combining mindfulness meditation, breathwork, and physical postures – is proposed to exert positive effects via improved sleep and emotion regulation, including better autonomic regulation, higher heart rate variability (HRV), and healthier sleep electroencephalography (EEG). Holistic yoga has enhanced effects over mindfulness-only interventions. Thus, yoga is a compelling, novel transdiagnostic solution for improving psychological distress/emotional difficulties, likely via improved sleep and emotion regulation. Meta-analyses demonstrate that yoga is efficacious for non-comorbid anxiety, major depressive (MDD), posttraumatic stress (PTSD), and alcohol use disorders. Yoga improves wellbeing and is popular, acceptable, and tolerable across a range of demographics. It has several advantages over gold standard mental health interventions like cognitive behavioural therapy (CBT), such as lower associated stigma, reduced healthcare wait times, and increased cost-effectiveness. Further, CBT response rates vary from 33-87% (average ~50%).

The Yoga intervention is a trauma-informed protocol we designed to enhance the holistic effects of yoga on mental wellbeing, sleep, and emotion regulation. It will consist of one, 90-min group session per week for 10-weeks plus 10-15-min daily home practice (recorded via diary) and will be delivered by student yoga teachers/yoga therapists from The Yoga Space/Wisdom Yoga Institute, Perth. Student yoga teachers/yoga therapists undergoing training must deliver classes (hours) to complete their qualifications and become registered and will deliver the group yoga on this project to complete their training hours (trained and supervised by co-proprietor Dr Byrne, Yoga Teacher Level 2, Senior Member YA, ERYT-500, Yoga Alliance RPYT).

Most yoga or CBT interventions with mental health efficacy average 8-12 sessions in total. In a 2021 Perth-based pilot randomised controlled trial (RCT) of yoga versus CBT for transdiagnostic mental health (N=12; 100% retention), we found that aligning schedules with school terms (i.e., 10 weekly sessions) was most feasible in Perth.

Yoga sessions will be audio recorded to assess protocol adherence. Group interventions will be conducted either in-person or via telehealth (pragmatic design) to increase scope and reach across Australia and to comply with general health recommendations and/or government mandates during the global pandemic, as necessary.
Intervention code [1] 323416 0
Treatment: Other
Intervention code [2] 323417 0
Rehabilitation
Intervention code [3] 323418 0
Behaviour
Comparator / control treatment
COGNITIVE BEHAVIOURAL THERAPY (CBT)

CBT is the first-line, gold standard, evidence-based treatment for mental health and therefore is an ideal active control comparison. The CBT for this trial is the Unified Protocol, a well-established, manualised, transdiagnostic CBT developed for emotional disorders and/or emotion regulation. It is effective for anxiety, MDD, PTSD, alcohol use, comorbidity, group delivery, and is equivalent to disorder-specific CBT.

CBT will consist of one, 90-min group session per week for 10-weeks plus 10-15-min daily home practice (recorded via diary) to match the Yoga intervention. It will be delivered by Murdoch postgraduate clinical psychology students (supervised by Dr Mathersul, registered psychologist with clinical psychology endorsement, board-approved clinical psychology supervisor).

As per the Yoga intervention, CBT sessions will be audio recorded to assess protocol adherence. Group interventions will be conducted either in-person or via telehealth (pragmatic design) to increase scope and reach across Australia and to comply with general health recommendations and/or government mandates during the global pandemic, as necessary.
Control group
Active

Outcomes
Primary outcome [1] 331147 0
Kessler Psychological Distress Scale (K10)
Timepoint [1] 331147 0
Baseline, post-intervention/end-of-treatment, 3-month follow-up, 6-month follow-up
Primary outcome [2] 331148 0
Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5) clinical severity ratings for subclinical and primary mental health disorders.
Timepoint [2] 331148 0
Baseline, post-intervention/end-of-treatment, 3-month follow-up, 6-month follow-up
Secondary outcome [1] 408996 0
Depression Anxiety Stress Scale (DASS-21)
Timepoint [1] 408996 0
Baseline, post-intervention/end-of-treatment, 3-month follow-up, 6-month follow-up
Secondary outcome [2] 408997 0
PTSD Checklist for DSM-5 (PCL-5)
Timepoint [2] 408997 0
Baseline, post-intervention/end-of-treatment, 3-month follow-up, 6-month follow-up
Secondary outcome [3] 408998 0
Alcohol Use Disorders Identification Test (AUDIT)
Timepoint [3] 408998 0
Baseline, post-intervention/end-of-treatment, 3-month follow-up, 6-month follow-up
Secondary outcome [4] 408999 0
Suicidal Ideation Attributes Scale (SIDAS)
Timepoint [4] 408999 0
Baseline, post-intervention/end-of-treatment, 3-month follow-up, 6-month follow-up
Secondary outcome [5] 409000 0
World Health Organisation Well-being Index (WHO5)
Timepoint [5] 409000 0
Baseline, post-intervention/end-of-treatment, 3-month follow-up, 6-month follow-up
Secondary outcome [6] 409001 0
World Health Organisation Disability Assessment Schedule (WHODAS)
Timepoint [6] 409001 0
Baseline, post-intervention/end-of-treatment, 3-month follow-up, 6-month follow-up
Secondary outcome [7] 409002 0
Mental Health Continuum (MHC-SF)
Timepoint [7] 409002 0
Baseline, post-intervention/end-of-treatment, 3-month follow-up, 6-month follow-up
Secondary outcome [8] 409003 0
Pittsburgh Sleep Quality Index (PSQI)
Timepoint [8] 409003 0
Baseline, mid-treatment, post-intervention/end-of-treatment, 3-month follow-up, 6-month follow-up
Secondary outcome [9] 409004 0
Perth Emotion Regulation Competency Inventory (PERCI)
Timepoint [9] 409004 0
Baseline, mid-treatment, post-intervention/end-of-treatment, 3-month follow-up, 6-month follow-up
Secondary outcome [10] 409005 0
Ecological Momentary Assessment (EMA) across 1-week, assessing sleep and emotion regulation in daily life via smartphone app
Timepoint [10] 409005 0
Baseline, mid-treatment, post-intervention/end-of-treatment, 3-month follow-up, 6-month follow-up
Secondary outcome [11] 409006 0
Actigraphy (sleep biomarker) via wristwatches worn for 1-week concurrently with EMA/HRV
Timepoint [11] 409006 0
Baseline, mid-treatment, post-intervention/end-of-treatment, 3-month follow-up, 6-month follow-up
Secondary outcome [12] 409007 0
Heart Rate Variability (HRV; emotion regulation biomarker) via ambulatory (chest monitors) worn for 1-week concurrently with EMA/actigraphy AND 5-min resting-state
Timepoint [12] 409007 0
Baseline, mid-treatment, post-intervention/end-of-treatment, 3-month follow-up, 6-month follow-up

Eligibility
Key inclusion criteria
At least one subclinical anxiety, major depressive (MDD), posttraumatic stress (PTSD), or alcohol use disorder, as indicated by a clinical severity rating of 3 or 3.5 on the ADIS-5.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. at least one comorbid mental health disorder, as assessed by the ADIS-5 (i.e., more than one anxiety, major depressive [MDD], posttraumatic stress [PTSD], or alcohol use disorder).
or
2. active psychosis or mania
or
3. severe neurological or substance use disorder preventing engagement.

Temporary exclusion criteria (i.e., may participate when stabilised):
1. recent hospitalisation or suicide attempt (in the last 2mths);
2. recent CBT/yoga (>2 sessions in last 2mths); or
3. medication change (in the last 6wks).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Yes. Allocation will occur via either sealed opaque envelopes (e.g., for in-person interventions) or names and group allocation drawn out of two hats concurrently (e.g., for telehealth interventions). Allocation will occur after eligibility decisions are made.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation. Each cohort will have an equal number of Yoga and CBT sealed envelopes or names/interventions in hats, with the total number set according to the number of participants enrolled in the cohort.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study is a single-blind non-inferiority RCT design to evaluate the efficacy of yoga versus CBT (active control) for emotional mental health difficulties (at least one subclinical mental health disorder).

Power Analyses (80% power; a=.05): Based on meta-analysis effect sizes for Yoga (.61-.90) and CBT (.62-1.06) and non-inferiority margins and standard deviations of the K10 (4.6, 9.4) and ADIS-5 (0.75, 1.62) primary outcome measures, a non-inferiority RCT requires N=104-120 treatment completers (up to n=60/group completers). Medium-large to large-large mediation requires N=34-74. Thus, taking a conservative approach (largest sample size) and assuming 70% retention, we will randomise N=172 participants to ensure N=120 completers.

Data Analyses:
Aim 1/Hypothesis 1 (Yoga non-inferiority to CBT): Noninferiority margins for K10 and ADIS-5 set at 4.6 and 0.75, respectively, based on previous RCTs and clinically meaningful change in scales. All analyses will be both intent-to-treat and per protocol, as recommended for non-inferiority RCTs. Mixed modelling analyses with repeated measures (K10/ADIS-5 severity over time) by group (Yoga vs. CBT) and confirmatory sensitivity analyses on self-report (DASS-21, PCL-5, AUDIT, SIDAS) and functional (WHO5, WHODAS, MHC-SF) outcome measures.

Aim 2/Hypothesis 2 (sleep and/or emotion regulation will moderate mental health outcome with Yoga vs. CBT): Mixed modelling analyses of baseline PSQI, PERCI, EMA, sleep actigraphy, HRV, predicting K10/ADIS-5 by group over time.

Aim 3/Hypothesis 3 (sleep and/or emotion regulation will mediate mental health): Mixed modelling analyses of change from baseline-to-mid-treatment of PSQI, PERCI, HRV, predicting K10/ADIS-5 severity by group.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/04/2022
Actual
28/04/2022
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
1/07/2026
Actual
Sample size
Target
172
Accrual to date
15
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment postcode(s) [1] 37388 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 311292 0
University
Name [1] 311292 0
Murdoch University
Country [1] 311292 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
90 South Street
Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 312654 0
Individual
Name [1] 312654 0
Danielle C. Mathersul
Address [1] 312654 0
Murdoch University
90 South Street
Building 440
Murdoch WA 6150
Country [1] 312654 0
Australia
Other collaborator category [1] 282266 0
Individual
Name [1] 282266 0
Peter J. Bayley
Address [1] 282266 0
VA Palo Alto Health Care System
Stanford University
3801 Miranda Ave
Palo Alto, CA 94304
Country [1] 282266 0
United States of America
Other collaborator category [2] 282267 0
Individual
Name [2] 282267 0
Peter M. McEvoy
Address [2] 282267 0
Curtin University
Centre for Clinical Interventions
Kent Street
Bentley WA 6102
Country [2] 282267 0
Australia
Other collaborator category [3] 282268 0
Individual
Name [3] 282268 0
Kristin Gainey
Address [3] 282268 0
University of Western Australia
35 Stirling Hwy
Crawley WA 6009
Country [3] 282268 0
Australia
Other collaborator category [4] 282269 0
Individual
Name [4] 282269 0
Jean Byrne
Address [4] 282269 0
The Yoga Space
6/79 Colin St
West Perth WA 6005
Country [4] 282269 0
Australia
Other collaborator category [5] 282270 0
Individual
Name [5] 282270 0
Rob Schütze
Address [5] 282270 0
Curtin University
The Yoga Space
Kent Street
Bentley WA 6102
Country [5] 282270 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310795 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 310795 0
Ethics committee country [1] 310795 0
Australia
Date submitted for ethics approval [1] 310795 0
18/12/2020
Approval date [1] 310795 0
02/02/2021
Ethics approval number [1] 310795 0
2020/511

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

Contacts
Principal investigator
Name 118894 0
Dr Danielle C. Mathersul
Address 118894 0
Murdoch University
90 South Street
Building 440
Murdoch WA 6150
Country 118894 0
Australia
Phone 118894 0
+61 8 9360 6542
Fax 118894 0
Email 118894 0
[email protected]
Contact person for public queries
Name 118895 0
Danielle C. Mathersul
Address 118895 0
Murdoch University
90 South Street
Building 440
Murdoch WA 6150
Country 118895 0
Australia
Phone 118895 0
+61 8 9360 6542
Fax 118895 0
Email 118895 0
[email protected]
Contact person for scientific queries
Name 118896 0
Danielle C. Mathersul
Address 118896 0
Murdoch University
90 South Street
Building 440
Murdoch WA 6150
Country 118896 0
Australia
Phone 118896 0
+61 8 9360 6542
Fax 118896 0
+61
Email 118896 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified IPD
When will data be available (start and end dates)?
Start date: Only once all data collection is completed (including follow-up) and the primary outcomes manuscript is published.

End date: No end date.
Available to whom?
On a case-by-case basis at the discretion of Principle Investigator (Dr Mathersul) upon written request by researchers who provide a methodologically sound proposal.
Available for what types of analyses?
IPD meta-analyses
How or where can data be obtained?
Subject to approvals by Principal Investigator ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15845Study protocol    To be published
15846Informed consent form    Available upon written request to the Principle In... [More Details]
15847Ethical approval    Available upon written request to the Principle In... [More Details]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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