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Trial registered on ANZCTR


Registration number
ACTRN12620000983909
Ethics application status
Approved
Date submitted
7/07/2020
Date registered
30/09/2020
Date last updated
30/09/2020
Date data sharing statement initially provided
30/09/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Yoga & Exercise for Mental Health Study
Scientific title
Effects of yoga and exercise on acute changes in mood in people with a common mental disorder: a randomised controlled crossover study
Secondary ID [1] 301701 0
Nil known
Universal Trial Number (UTN)
U1111-1254-8839
Trial acronym
n/a
Linked study record
n/a

Health condition
Health condition(s) or problem(s) studied:
depression 318154 0
anxiety 318155 0
Condition category
Condition code
Mental Health 316174 316174 0 0
Depression
Mental Health 316175 316175 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All conditions will be supervised by an Accredited Exercise Physiologist and delivered in a one-on-one format. Due to the cross-over study design, participants will complete 1 x each condition (including both control conditions) exactly 1 week apart. The week in between each condition is the allocated wash-out period. Home adherence is not required for this study.
Mindfulness-based yoga (Yin): a very light, non­-active form of yoga that involves long durations (2-4 minutes) in relaxed postures with a focus on mindfulness and awareness to bodily sensations, thoughts, breathing. This will be lead by a video recording for standardisation and will go for 30 minutes. (20-point Borg RPE should be below 8)
Exercise & Mindfulness-based yoga (Vinyasa): a moderate-intensity form of yoga that requires attention to breath and bodily movements. A focus on alignment and muscular engagement with some 'flow' sequences (i.e. each breath is synced with one movement). This will be lead by a video recording for standardisation and will go for 30 minutes. (advised Borg RPE = 13)
Aerobic exercise: 30 minutes of moderate ­intensity (self­-selected intensity with the instruction of maintaining a Rating of Perceived Exertion: 13) on an exercise bike. Including 5 minutes or warm up at the start and 5 minutes of cool down at the end (30 minutes total). (advised Borg RPE = 13)
Intervention code [1] 318007 0
Treatment: Other
Comparator / control treatment
Attention control: 30 minutes of self ­selected reading.
Sham control: 30 minutes of stretching directed by images presented on a powerpoint point presentation. Stretches include: supine knees tucked low back stretch, supine hamstring stretch, seated forward fold, wide leg forward fold, adductor stretch with lateral flexion, seated twist, childs pose, hip flexor stretch in lunge with knee down, prone quad stretch, cobra (spinal extension with forearms), supine twist. This condition will be supervised by an Accredited Exercise Physiologist and will be delivered in a one-on-one format. Each participant will complete 1 x 30 minute stretching condition throughout the study.
Control group
Active

Outcomes
Primary outcome [1] 324354 0
Change in mood assessed by Profile of Mood State
Timepoint [1] 324354 0
At baseline assessment
Pre-intervention commencement and immediately post-intervention (condition X, week 1)
Pre-intervention commencement and immediately post-intervention (condition X, week 2)
Pre-intervention commencement and immediately post-intervention (condition X, week 3)
Pre-intervention commencement and immediately post-intervention (condition X, week 4)
Pre-intervention commencement and immediately post-intervention (condition X, week 5)
*Condition order will be randomised. Only 1 condition will be completed each week.
Primary outcome [2] 324355 0
Treatment expectations assessed using the Credibility Expectancy of Intervention Condition questionnaire
Timepoint [2] 324355 0
Pre-intervention for each condition, total of 5 conditions. E.g. Prior to beginning every intervention condition.
Secondary outcome [1] 384426 0
Symptom severity of depression, anxiety and stress as measured by the composite Depression Anxiety & Stress Scale (DASS-21) questionnaire
Timepoint [1] 384426 0
At baseline pre-intervention commencement
Pre each intervention session, weekly (x5)
Secondary outcome [2] 384427 0
Subjective sleep quality (composite score that includes sleep latency, sleep duration, sleep disturbance and waking feeling rested in the score) as measured by the Sleep Quality Scale questionnaire.
Timepoint [2] 384427 0
At baseline, pre-intervention commencement
Pre each intervention condition and 24 hours post intervention condition (weekly, x5)
Secondary outcome [3] 384428 0
Central blood pressure assessed using sphygmomanometer
Timepoint [3] 384428 0
At baseline, pre-intervention commencement
Immediately pre and immediately post each intervention condition each week (x5)
Secondary outcome [4] 384429 0
Blood glucose levels as assessed by an AccuCheck Glucometer
Timepoint [4] 384429 0
At baseline, pre-intervention commencement
Immediately pre and immediately post each intervention condition each week (x5)
Secondary outcome [5] 386509 0
Augmentation Index assessed using sphygmomanometer
Timepoint [5] 386509 0
At baseline, pre-intervention commencement
Immediately pre and immediately post each intervention condition each week (x5)
Secondary outcome [6] 386510 0
Brachial systolic and diastolic blood pressure assessed using sphygmomanometer
Timepoint [6] 386510 0
At baseline, pre-intervention commencement
Immediately pre and immediately post each intervention condition each week (x5)

Eligibility
Key inclusion criteria
Moderate to severe score of depression and/or anxiety as per the Structured Clinical Interview for DSM-5.
Minimum age
18 Years
Maximum age
44 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
If a mental disorder (e.g. psychotic or personality disorders) impairs the participants ability to give informed consent, comprehend reading/writing tasks and/or participate reliably.
A physical (e.g., amputation without adequate prosthetic, uncontrolled blood pressure) or cognitive impairment is present that would hinder or restrict any part of the study requirements.
Unable to speak, read or write in English.
Medication has changed within 4 weeks prior to the intervention.
Already undertake a personal yoga or meditation practice (of more than once a week over the last 3 months).

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computer generated randomisation website: https://www.randomizer.org/
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
A conservative calculation for a sample size of 55 uses the conventional medium effect size for the F-test of the interaction of a 5 (condition) x 2 (time) repeated-­measures ANOVA at 80% power, 5% type­-1 error, not correcting for lack of sphericity. Due to no previous literature available to determine accurate required numbers, another statistical calculation was completed to detect a minimum within­ subject effect size of 0.6 between a vinyasa condition and a yin condition in an AB/BA crossover study design. Within­-subject Cohen's d effect sizes (Minami et al. 2008) were calculated for the pre­-post differences within Bartholomew, Morrison and Ciccolo (2005) inactive control group and physical exercise groups. We estimated the difference between Vinyasa and Yin yoga would be approximately equivalent to the difference between physical exercise and inactive control in the Bartholomew et al (2005) study: within­-group Cohen's d equal to 0.6. To have 80% power to detect a difference of this size with a two-­tailed test with a 5% type-1 error rate would require 24 participants (Senn & Senn 2002). Accounting for drop out, an additional 30% has been factored into the sample size, with a total of 31 participants required for this study. We will aim to recruit 55 participants for this study, but on the advice of our statistician we will run preliminary analyses when 24 participants is reached to ensure we are not under or over­powering. If the effect size estimate is consistent with predictions but the F-­test is not statistically significant, recruitment will continue until 55 are recruited. If the effect size appears to be significantly over­estimated, the study will halt at this point.
Repeated measures 2­factor (time, condition) ANOVAs will be used.
A Condition (5; aerobic, vinyasa, yin, stretching, control) x Time (3; pre, post, 24­hour post) repeated measures analysis of variance (ANOVA) will be used to assess for differences in mood. Carryover effects will be tested for in the same model by using a sequence*outcome interaction term. A linear mixed model may be utilized for the analysis if missing data is a factor.
An order effect will be applied to the analysis to test whether there is a main effect of group order, if yes, it will remain in the analysis to control for the variance.
Changes in pre­-post scores of depression, anxiety and stress, anthropometry, cardiorespiratory fitness and strength from commencement to conclusion of intervention will be analysed with a one­way ANOVA.If a larger sample size of 55 is recruited, repeated measures 2­ factor (time, condition) ANOVAs will be used.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 306138 0
University
Name [1] 306138 0
University of South Australia
Address [1] 306138 0
GPO Box 2471
Adelaide
South Australia 5001
Country [1] 306138 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
GPO Box 2471
Adelaide
South Australia 5001
Country
Australia
Secondary sponsor category [1] 306608 0
None
Name [1] 306608 0
Address [1] 306608 0
Country [1] 306608 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306355 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 306355 0
Research Ethics and Integrity
University of South Australia
Mawson Lakes Campus, Mawson Lakes Blvd, Mawson Lakes, SA, 5095

GPO Box Adress:
GPO Box 2471
Adelaide, South Australia 5001
Ethics committee country [1] 306355 0
Australia
Date submitted for ethics approval [1] 306355 0
25/09/2019
Approval date [1] 306355 0
21/02/2020
Ethics approval number [1] 306355 0
202462

Summary
Brief summary
Almost half of Australians will have a mental health condition in their lifetime, with 3 million adults having anxiety and/or depression in any year. Exercise has recently received a lot of attention for its ability to help prevent and manage symptoms of depression, as well as improving physical health. Mindfulness, which is attention to the present moment, also demonstrates positive effects on mood and mental health, however, not much is known about the effects of combining the two activities on mood in people with depression/anxiety. Yoga is an increasingly popular activity in Australia, and essentially combines exercise and mindfulness together in varying combinations, depending on the type of yoga practiced. We are interested in the effect of different combinations of exercise and mindfulness, such as exercise without mindfulness (cycling), mindfulness without exercise (yin yoga) and exercise and mindfulness combined (vinyasa yoga), has on mood state in people with depression and/or anxiety.
This study involves doing a 30-minute bout of different combinations of yoga, exercise and mindfulness each week, and goes for 6 weeks in total. We are interested in measuring mood state, depression, anxiety & stress scores, sleep quality, expectation of the condition’s effectiveness, as well as some basic physical health measures such as blood pressure and blood glucose levels, before and after each session.
The primary aim of this study is to investigate and compare changes in mood in people with diagnosed depression/anxiety after engaging in 30 minutes of physically active yoga (vinyasa) or non-physically active yoga (yin).
The hypotheses for the study are:
1. Physically active yoga (vinyasa) will have a greater effect on improving mood in people with depression/anxiety than mindfulness-based yoga (yin).
2. Physically active yoga (vinyasa) will have a greater effect on improving mood in people with depression/anxiety than sham control and attention control.
3. Mindfulness-based yoga (yin) will have a greater effect on improving mood in people with depression/anxiety than sham control and attention control.
Secondary questions that we intend to explore are:
1. Are acute changes in mood present 24 hours post yoga?
2. What are the acute effects of vinyasa and yin yoga on cardio-metabolic health measures (central blood pressure, augmentation index, blood glucose levels)?
3. Which condition scored the highest on the credibility expectancy questionnaire?
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103594 0
Ms Jacinta Brinsley
Address 103594 0
University of South Australia
P2-42, City East Campus
GPO Box 2471
Adelaide SA 5001
Country 103594 0
Australia
Phone 103594 0
+61 439769123
Fax 103594 0
Email 103594 0
jacintabrinsley@hotmail.com
Contact person for public queries
Name 103595 0
Ms Jacinta Brinsley
Address 103595 0
University of South Australia
P2-42, City East Campus
GPO Box 2471
Adelaide SA 5001
Country 103595 0
Australia
Phone 103595 0
+61 439769123
Fax 103595 0
Email 103595 0
jacintabrinsley@hotmail.com
Contact person for scientific queries
Name 103596 0
Ms Jacinta Brinsley
Address 103596 0
University of South Australia
P2-42, City East Campus
GPO Box 2471
Adelaide SA 5001
Country 103596 0
Australia
Phone 103596 0
+61 439769123
Fax 103596 0
Email 103596 0
jacintabrinsley@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Raw line-by-line data of outcome measures.
When will data be available (start and end dates)?
Data will be available immediately upon request following publication of the main results and ending 7 years from date of publication.
Available to whom?
Researchers
Available for what types of analyses?
For example, in the case of inclusion in a meta-analysis where all required data is not reported in the manuscript.
How or where can data be obtained?
Data can be obtained by contacting the principal investigator and will be provided in an excel document via email.
Contact can be made via email to: jacintabrinsley.aep@gmail.com
What supporting documents are/will be available?
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 8409 0
Ethical approval
Citation [1] 8409 0
Link [1] 8409 0
Email [1] 8409 0
Other [1] 8409 0
Type [2] 8410 0
Informed consent form
Citation [2] 8410 0
Link [2] 8410 0
Email [2] 8410 0
Other [2] 8410 0
Summary results
No Results