Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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.
Scientific title
Effect of yoga on neurocognitive outcomes in young adults with depression: a waitlist randomized controlled trial.
Secondary ID [1] 311870 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Symptomatic Depression 333419 0
Condition category
Condition code
Mental Health 330099 330099 0 0
Depression
Physical Medicine / Rehabilitation 330800 330800 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 328327 0
Treatment: Other
Intervention code [2] 328846 0
Lifestyle
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.
Control group
Active

Outcomes
Primary outcome [1] 337855 0
Global cognition
Timepoint [1] 337855 0
Baseline and post-completion of intervention
This will also be assessed at 12 weeks post-completion of intervention as an exploratory measure.
Secondary outcome [1] 434381 0
Cortical inhibition
Timepoint [1] 434381 0
Baseline and post-completion of intervention
This will also be assessed at 12 weeks post-completion of intervention as an exploratory measure.
Secondary outcome [2] 434382 0
Cerebrovascular function
Timepoint [2] 434382 0
Baseline and post-completion of intervention
This will also be assessed at 12 weeks post-completion of intervention as an exploratory measure.
Secondary outcome [3] 434383 0
Blood biomarker of stress
Timepoint [3] 434383 0
Baseline and post-completion of intervention
This will also be assessed at 12 weeks post-completion of intervention as an exploratory measure.
Secondary outcome [4] 434384 0
Depression severity
Timepoint [4] 434384 0
Baseline and post-completion of intervention
This will also be assessed at 12 weeks post-completion of intervention as an exploratory measure.
Secondary outcome [5] 436783 0
Blood biomarker of Neurogenensis
Timepoint [5] 436783 0
Baseline and Post-completion of intervention
This will also be assessed at 12 weeks post-completion of intervention as an exploratory measure.
Secondary outcome [6] 436788 0
Flourishing
Timepoint [6] 436788 0
Baseline and post-completion of intervention
This will also be assessed at 12 weeks post-completion of intervention as an exploratory measure.
Secondary outcome [7] 436790 0
Self-compassion
Timepoint [7] 436790 0
Baseline and post-completion of intervention
This will also be assessed at 12 weeks post-completion of intervention as an exploratory measure.
Secondary outcome [8] 436793 0
Mindfulness
Timepoint [8] 436793 0
Baseline and Post-completion of intervention
This will also be assessed at 12 weeks post-completion of intervention as an exploratory measure.
Secondary outcome [9] 436944 0
Memory
Timepoint [9] 436944 0
Baseline and post-completion of intervention
This will also be assessed at 12 weeks post-completion of intervention as an exploratory measure.
Secondary outcome [10] 436945 0
Attention and processing speed
Timepoint [10] 436945 0
Baseline and post-completion of intervention
This will also be assessed at 12 weeks post-completion of intervention as an exploratory measure.
Secondary outcome [11] 436946 0
Working Memory
Timepoint [11] 436946 0
Baseline and post-completion of intervention
This will also be assessed at 12 weeks post-completion of intervention as an exploratory measure.
Secondary outcome [12] 436947 0
Cognitive interference
Timepoint [12] 436947 0
Baseline and post-completion of the intervention
This will also be assessed at 12 weeks post-completion of intervention as an exploratory measure.
Secondary outcome [13] 436948 0
Perseveration and Abstract Reasoning
Timepoint [13] 436948 0
Baseline and Post completion of the intervention
This will also be assessed at 12 weeks post-completion of intervention as an exploratory measure.
Secondary outcome [14] 437391 0
Biomarker of neurodegeneration
Timepoint [14] 437391 0
This will be assessed at baseline, post completion of the intervention and 12 weeks post completion of intervention as an exploratory measure.
Secondary outcome [15] 437394 0
Biomarker of neuroactive metabolites
Timepoint [15] 437394 0
This will be assessed at baseline, post-completion of intervention and 12 weeks post completion of intervention as an exploratory outcome measure.
Secondary outcome [16] 437395 0
Biomarkers of inflammation
Timepoint [16] 437395 0
This will be assessed at baseline, post-completion of intervention and 12 weeks post completion of intervention as an exploratory outcome measure.

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
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

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)
Allocation will be concealed by using sealed opaque envelopes, which will be drawn by a person independent to the study at Victoria University.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
The allocation ratio of the participants will be 2:1.
Phase
Not Applicable
Type of endpoint/s
Efficacy
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).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2024
Actual
Date of last participant enrolment
Anticipated
30/12/2025
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
51
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316212 0
University
Name [1] 316212 0
Victoria University
Country [1] 316212 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
Country
Australia
Secondary sponsor category [1] 318396 0
None
Name [1] 318396 0
Address [1] 318396 0
Country [1] 318396 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315029 0
Victoria University Human Research Ethics Committee
Ethics committee address [1] 315029 0
https://www.vu.edu.au/researchers/research-lifecycle/conducting-research/human-research-ethics/vu-human-research-ethics-committee-vuhrec
Ethics committee country [1] 315029 0
Australia
Date submitted for ethics approval [1] 315029 0
27/03/2024
Approval date [1] 315029 0
27/06/2024
Ethics approval number [1] 315029 0

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.
Trial website
Trial related presentations / publications
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.

Contacts
Principal investigator
Name 133478 0
Dr James Broatch
Address 133478 0
Victoria University Institute for Health and Sport (IHES) Ballarat Road Footscray VIC, 3011
Country 133478 0
Australia
Phone 133478 0
+61399196283
Fax 133478 0
Email 133478 0
[email protected]
Contact person for public queries
Name 133479 0
Niranjan Parajuli
Address 133479 0
Victoria University Institute for Health and Sport (IHES) Ballarat Road Footscray VIC, 3011
Country 133479 0
Australia
Phone 133479 0
+61 450752045
Fax 133479 0
Email 133479 0
[email protected]
Contact person for scientific queries
Name 133480 0
Niranjan Parajuli
Address 133480 0
Victoria University Institute for Health and Sport (IHES) Ballarat Road Footscray VIC, 3011
Country 133480 0
Australia
Phone 133480 0
+61 450752045
Fax 133480 0
Email 133480 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.