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Yoga or cognitive behavioural therapy for psychological distress and emotional difficulties: Can our neurophysiology predict treatment efficacy?

Transdiagnostic treatments for emotional resilience: Efficacy and mechanisms of yoga versus cognitive behavioural therapy

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000624785
Enrollment
15
Registered
2022-04-28
Start date
2022-04-28
Completion date
2024-09-23
Last updated
2025-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Almost half of all Australians experience a mental health disorder in their lifetime. Consistent with dimensional, transdiagnostic conceptualisations of mental health, many individuals experiencing high levels of psychological distress and emotional difficulties may fall short of formal diagnostic criteria for a mental health disorder yet are in need of psychological intervention. Indeed, these so-called "subclinical" disorders are key predictors of future mental health disorder development and are associated with poorer functioning and lower quality of life. At the same time, the COVID-19 pandemic has increased psychological distress and yet reduced access to gold standard mental health treatment like cognitive behavioural therapy (CBT). A paradigm shift is needed to increase the evidence-base and availability of mental health interventions. A “transdiagnostic” treatment approach where an intervention targets shared processes underlying psychological/emotional distress (e.g., sleep, emotion regulation) rather than disorder-specific symptoms is an innovative way to improve and prevent poor mental health. Individuals with better sleep and emotion regulation have less intense and persistent negative emotions in response to environmental stressors (e.g., pandemics, bushfires, floods), thus protecting against poor mental health. Yoga, a combination of mindfulness meditation, breathwork, and physical postures, is a compelling novel transdiagnostic solution. Yoga is efficacious for prevalent and comorbid mental health disorders associated with high psychological distress among Australians: anxiety, major depressive, posttraumatic stress, and alcohol use disorders. Yoga is also popular and has several advantages over first-line CBT like lower associated stigma and wait times and increased cost-effectiveness. Yoga is proposed to exert positive effects via improved sleep and emotion regulation. This innovative research aims to establish yoga efficacy for psychological/emotional distress (at least subclinical mental health) and to assess if sleep and/or emotion regulation are moderators and/or mediators of mental health outcome. It will use a non-inferiority randomised controlled trial design with CBT as the active control and both subjective (questionnaires, ecological momentary assessment) and objective (actigraphy, heart rate variability) measures of sleep and emotion regulation. This research will bring about a paradigm shift in mental health care and advance precision medicine.

Interventions

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

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.

Sponsors

Murdoch University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026