None listed
Conditions
Brief summary
Almost half of all Australians experience a mental health disorder in their lifetime. Comorbidity is the norm and is associated with poorer functioning and lower quality of life. The COVID-19 pandemic has increased psychological distress and 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 comorbidity (e.g., sleep, emotion regulation) rather than disorder-specific symptoms is an innovative way to improve comorbid 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 among Australians: anxiety, major depressive, posttraumatic stress, and alcohol use disorders. Yet no study has assessed yoga efficacy for comorbid mental health. Yoga is 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 comorbid 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 comorbid mental health, likely via improved
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 comorbid mental health, 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. However, no study has yet assessed the efficacy of yoga for comorbid mental health. 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%) and efficacy is lower and drop-out higher for disorders with high comorbidity (cooccurrence) rates. 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
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
1. primary diagnosis of anxiety, major depressive (MDD), posttraumatic stress (PTSD), or alcohol use disorders and 2. at least one comorbid mental health disorder as assessed by the ADIS-5.
Exclusion criteria
1. active psychosis or mania or 2. 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