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Trial registered on ANZCTR
Registration number
ACTRN12624000872538
Ethics application status
Approved
Date submitted
5/06/2024
Date registered
17/07/2024
Date last updated
17/07/2024
Date data sharing statement initially provided
17/07/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Effect of Yoga on neurocognitive function among individuals with symptoms of depression.
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Scientific title
Effect of yoga on neurocognitive outcomes in young adults with depression: a waitlist randomized controlled trial.
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Secondary ID [1]
311870
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Symptomatic Depression
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Condition category
Condition code
Mental Health
330099
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0
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Depression
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Physical Medicine / Rehabilitation
330800
330800
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0
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Other physical medicine / rehabilitation
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The participants will be provided with a 12-week yoga intervention, consisting of three guided sessions per week. Participants will be required to physically attend three sessions with the yoga instructor on weeks 1, 5 and 9. The remaining guided sessions will be done using the Zoom platform. Although it is not compulsory, participants will be encouraged to engage in home-based yoga practice on the remaining days of the week by the yoga instructor. A URL link to yoga videos and instruction manuals will be provided to the participants on the first day of the yoga session. Yoga sessions will be conducted by a trained yoga therapist. Participants in the experimental group will be divided into three groups (2 groups of 11 and one group of 12). When participants are unable to attend a scheduled group session, the yoga instructor will follow up with the participant to arrange 1:1 delivery of the sessions via zoom. Participants will be provided with a logbook to keep the record of unsupervised session at home. To ensure adherence, attendance of participants in supervised sessions will be kept by the yoga instructor.
The yoga classes will be 45 minutes each and the sequence has been developed based on research on yoga and depression. The yoga module is structured in a progressive order, with certain practices being removed, new practices being introduced, or the repetition of some existing practices being increased triweekly.
Yoga in this project refers to hatha yoga, which comprises sun salutations (surya namaskara), yoga postures (asanas), breath control/exercise (pranayama), and guided relaxation (dhyana). The designed yoga module meets the criteria for a moderate level of physical activity.
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Intervention code [1]
328327
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Treatment: Other
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Intervention code [2]
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Lifestyle
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Comparator / control treatment
This is a randomized wait-list control trial. The participant in the control group will be offered the yoga intervention after the 3 month follow up.
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Control group
Active
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Outcomes
Primary outcome [1]
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Global cognition
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Assessment method [1]
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Several Cognition domains will be measured using Colour Trail Test 1 and 2 (CTT1 and CTT2), Rey Auditory Verbal Learning Test (RAVLT), Wisconsin Card Sorting Test - 64 Card Version (WCST-64), Working Memory Index (WMI), a sub-scale of the Wechsler Adult Intelligence Scale, and Stroop Colour and Word Test (SCWT).
The raw score for each cognitive test will be converted to z score and averaged to yield a global cognition score.
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Timepoint [1]
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Baseline and post-completion of intervention
This will also be assessed at 12 weeks post-completion of intervention as an exploratory measure.
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Secondary outcome [1]
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Cortical inhibition
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Assessment method [1]
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Paired pulse transcranial magnetic stimulation paradigms and electromyography obtained from the abductor pollicis brevis muscle of the right hand will be compositely used to measure cortical inhibition.
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Timepoint [1]
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Baseline and post-completion of intervention
This will also be assessed at 12 weeks post-completion of intervention as an exploratory measure.
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Secondary outcome [2]
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Cerebrovascular function
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Assessment method [2]
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Dynamic brain vascular function will be assessed via blood flow velocity through a main artery in the brain (right middle cerebral artery; MCAv), measured by transcranial Doppler ultrasound (TCD). MCAv will be measured in normal condition and condition designed to challenge brain vasculature and provide information as to the functional responsiveness to the blood carbon dioxide (Cerebrovascular reactivity to hypercapnia).
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Timepoint [2]
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Baseline and post-completion of intervention
This will also be assessed at 12 weeks post-completion of intervention as an exploratory measure.
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Secondary outcome [3]
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Blood biomarker of stress
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Assessment method [3]
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Serum cortisol will be analyzed from participant blood samples.
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Timepoint [3]
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Baseline and post-completion of intervention
This will also be assessed at 12 weeks post-completion of intervention as an exploratory measure.
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Secondary outcome [4]
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Depression severity
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Assessment method [4]
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16-items Quick Inventory of Depressive Symptomology Self-Report
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Timepoint [4]
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Baseline and post-completion of intervention
This will also be assessed at 12 weeks post-completion of intervention as an exploratory measure.
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Secondary outcome [5]
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Blood biomarker of Neurogenensis
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Assessment method [5]
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Brain Derived Neurotropic Factor (BDNF) will be analyzed from participant blood samples.
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Timepoint [5]
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Baseline and Post-completion of intervention
This will also be assessed at 12 weeks post-completion of intervention as an exploratory measure.
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Secondary outcome [6]
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Flourishing
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Assessment method [6]
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Flourishing scale
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Timepoint [6]
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Baseline and post-completion of intervention
This will also be assessed at 12 weeks post-completion of intervention as an exploratory measure.
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Secondary outcome [7]
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Self-compassion
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Assessment method [7]
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Self-compassion scale short form
This will also be assessed at 12 weeks post-completion of intervention as an exploratory measure.
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Timepoint [7]
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Baseline and post-completion of intervention
This will also be assessed at 12 weeks post-completion of intervention as an exploratory measure.
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Secondary outcome [8]
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Mindfulness
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Assessment method [8]
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Freiburg Mindfulness Inventory
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Timepoint [8]
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Baseline and Post-completion of intervention
This will also be assessed at 12 weeks post-completion of intervention as an exploratory measure.
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Secondary outcome [9]
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Memory
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Assessment method [9]
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Rey Auditory Verbal Learning Test (RAVLT)
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Timepoint [9]
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Baseline and post-completion of intervention
This will also be assessed at 12 weeks post-completion of intervention as an exploratory measure.
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Secondary outcome [10]
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Attention and processing speed
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Assessment method [10]
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Attention and processing speed will be compositely assesses using Trial making test (1 and 2).
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Timepoint [10]
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Baseline and post-completion of intervention
This will also be assessed at 12 weeks post-completion of intervention as an exploratory measure.
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Secondary outcome [11]
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Working Memory
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Assessment method [11]
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Working Memory Index (WMI), a sub-scale of the Wechsler Adult Intelligence Scale
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Timepoint [11]
436946
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Baseline and post-completion of intervention
This will also be assessed at 12 weeks post-completion of intervention as an exploratory measure.
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Secondary outcome [12]
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Cognitive interference
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Assessment method [12]
436947
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Stroop Colour and Word Test (SCWT)
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Timepoint [12]
436947
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Baseline and post-completion of the intervention
This will also be assessed at 12 weeks post-completion of intervention as an exploratory measure.
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Secondary outcome [13]
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Perseveration and Abstract Reasoning
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Assessment method [13]
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Perseveration and Abstract Reasoning will be compositely assessed using Wisconsin Card Sorting Test - 64 Card Version (WCST-64)
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Timepoint [13]
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Baseline and Post completion of the intervention
This will also be assessed at 12 weeks post-completion of intervention as an exploratory measure.
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Secondary outcome [14]
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Biomarker of neurodegeneration
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Assessment method [14]
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Neurofilament light chain will be analyzed from participants blood samples.
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Timepoint [14]
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This will be assessed at baseline, post completion of the intervention and 12 weeks post completion of intervention as an exploratory measure.
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Secondary outcome [15]
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Biomarker of neuroactive metabolites
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Assessment method [15]
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Kynurenine pathway metabolites will be analyzed from participant blood samples.
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Timepoint [15]
437394
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This will be assessed at baseline, post-completion of intervention and 12 weeks post completion of intervention as an exploratory outcome measure.
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Secondary outcome [16]
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Biomarkers of inflammation
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Assessment method [16]
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Pro-inflammatory cytokines will be analyzed from the participants blood samples.
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Timepoint [16]
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This will be assessed at baseline, post-completion of intervention and 12 weeks post completion of intervention as an exploratory outcome measure.
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Eligibility
Key inclusion criteria
• Individuals with scores 11 to 20 in 16-items Quick Inventory of Depressive Symptomology Self-Report (QIDS-SR)
• Able to participate in 36 yoga sessions over 12 weeks
• Aged between 18 to 45 years
• Body Mass Index (BMI) 18 to 40
• All genders
• Able to read and write in English
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Minimum age
18
Years
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Maximum age
45
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• Individuals with score less than 11 (mild or no symptom of depression) and above 20 (very severe depression) in 16-items Quick Inventory of Depressive Symptomology Self-Report (QIDS-SR)
• Involved in regular mindfulness-based activity (3 or more days per week, or more than 150 min of mindfulness-based activity per week) in the previous 3 months
• Significant medical co-morbidities precluding participation in a yoga intervention (e.g., severe cardiovascular disease)
• Colour blindness
• Individuals with suicide ideation or history of suicide attempts
• A previous history and co-morbidities of other psychiatric (excluding anxiety disorder), neurological diseases and substance abuse
• Hearing deficits
• Pregnancy and physical deformities
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed by using sealed opaque envelopes, which will be drawn by a person independent to the study at Victoria University.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated to two groups (yoga and wait-list control) using computerized sequence generation with blocks of varying size and randomized order. Randomization will be stratified by gender (male or female) and severity of depression symptoms.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Other
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Other design features
The allocation ratio of the participants will be 2:1.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Sample size was calculated based on a systematic review and meta-analysis that used SMD ± 95%CI to assess the different cognitive domains (e.g., attention, memory, and executive function). The lowest SMD (intervention vs sham/control) was 0.96. Based on this the total sample size of 42 was calculated with alpha error at 5% and 80% power; yoga (n=28) and control (n = 14). Assuming 20% attrition rate, the target sample size is increased to 51: yoga (n = 34) and control (n = 17).
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/08/2024
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Actual
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Date of last participant enrolment
Anticipated
30/12/2025
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Actual
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Date of last data collection
Anticipated
1/06/2026
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Actual
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Sample size
Target
51
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Victoria University
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Victoria University
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
318396
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Victoria University Human Research Ethics Committee
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Ethics committee address [1]
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https://www.vu.edu.au/researchers/research-lifecycle/conducting-research/human-research-ethics/vu-human-research-ethics-committee-vuhrec
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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27/03/2024
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Approval date [1]
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27/06/2024
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Ethics approval number [1]
315029
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Summary
Brief summary
Depression is associated with moderate impairment in cognition, and this impairment is associated with functional impairment and even suicide. Second generation antidepressants and psychotherapies are first line treatment for depression. However, impairment in cognition among individuals with depression persists even after receiving conventional treatment, resulting in an urge to investigate alternative treatment modalities such as yoga. Yoga is known to improve cognition, neurobiological and psychological outcomes in various populations, however these studies are limited by study design, sample size, and heterogenous nature of population, and further randomized controlled trials are warranted. Hence, the present study is designed to assess the effect of yoga on cognition (i.e., neuropsychological tests), neurobiological (i.e., markers of stress, neuroplasticity, neurodegeneration and cortical inhibition) and psychological outcomes (i.e., psychological questionnaires) in individuals with depression. In this uneven two-arm randomized control trial, participants of both genders, aged 18 to 45 years and having moderate to severe depression as measured by ‘Quick Inventory of Depressive Symptomology Self-Report’, will be randomly allocated into 12 weeks yoga intervention (n = 34) or waitlist control (n = 17) groups. Participants in the intervention group will perform yoga, 3 days a week for 12 weeks, while participants in the waitlist group will be provided with yoga training after the 12 weeks follow-up. Outcome assessments will be done at baseline (t1), at the end of the 12 (t2) and 24 (t3) weeks. The primary outcome will be between group differences on global cognition from t1 to t2. Secondary and tertiary outcomes will assess between and within (yoga group only) differences in a number of cognitive functions, neurobiological markers and psychological outcomes associated with mental health and/or depression severity, across all time points.
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Trial website
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Trial related presentations / publications
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Public notes
The mediating effect of psychological outcomes (mindfulness and self-compassion), neurological outcomes (cortisol, pro-inflammatory cytokines, brain derived neurotropic factor, neurofilament light chain and Kynurenine pathway metabolites) and cognition (memory, attention and processing speed, working memory, preseveration and abstract thinking, and cognitive interference) on depression severity and flourishing from baseline to post-completion of intervention will be assessed as a tertiary outcome measure.
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Contacts
Principal investigator
Name
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Dr James Broatch
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Address
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Victoria University Institute for Health and Sport (IHES) Ballarat Road Footscray VIC, 3011
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Country
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Australia
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Phone
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+61399196283
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Niranjan Parajuli
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Address
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Victoria University Institute for Health and Sport (IHES) Ballarat Road Footscray VIC, 3011
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Country
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Australia
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Phone
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+61 450752045
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Niranjan Parajuli
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Address
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Victoria University Institute for Health and Sport (IHES) Ballarat Road Footscray VIC, 3011
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Country
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Australia
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Phone
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+61 450752045
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
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.
Download to PDF