ANZCTR - Registration

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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

11/08/2022

Date data sharing statement initially provided

30/09/2020

Date results provided

11/08/2022

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]

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

anxiety

Condition category

Condition code

Mental Health

Depression

Mental Health

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]

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]

Change in mood assessed by Profile of Mood State

Timepoint [1]

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]

Treatment expectations assessed using the Credibility Expectancy of Intervention Condition questionnaire

Timepoint [2]

Pre-intervention for each condition, total of 5 conditions. E.g. Prior to beginning every intervention condition.

Secondary outcome [1]

Symptom severity of depression, anxiety and stress as measured by the composite Depression Anxiety & Stress Scale (DASS-21) questionnaire

Timepoint [1]

At baseline pre-intervention commencement
Pre each intervention session, weekly (x5)

Secondary outcome [2]

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]

At baseline, pre-intervention commencement
Pre each intervention condition and 24 hours post intervention condition (weekly, x5)

Secondary outcome [3]

Central blood pressure assessed using sphygmomanometer

Timepoint [3]

At baseline, pre-intervention commencement
Immediately pre and immediately post each intervention condition each week (x5)

Secondary outcome [4]

Blood glucose levels as assessed by an AccuCheck Glucometer

Timepoint [4]

At baseline, pre-intervention commencement
Immediately pre and immediately post each intervention condition each week (x5)

Secondary outcome [5]

Augmentation Index assessed using sphygmomanometer

Timepoint [5]

At baseline, pre-intervention commencement
Immediately pre and immediately post each intervention condition each week (x5)

Secondary outcome [6]

Brachial systolic and diastolic blood pressure assessed using sphygmomanometer

Timepoint [6]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

Actual

4/08/2020

Date of last participant enrolment

Anticipated

23/02/2021

Actual

10/05/2021

Date of last data collection

Anticipated

13/04/2021

Actual

11/06/2021

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of South Australia

Address [1]

GPO Box 2471
Adelaide
South Australia 5001

Country [1]

Australia

Primary sponsor type

University

Name

University of South Australia

Address

GPO Box 2471
Adelaide
South Australia 5001

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of South Australia Human Research Ethics Committee

Ethics committee address [1]

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]

Australia

Date submitted for ethics approval [1]

25/09/2019

Approval date [1]

21/02/2020

Ethics approval number [1]

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

Ms Jacinta Brinsley

Address

University of South Australia
P2-42, City East Campus
GPO Box 2471
Adelaide SA 5001

Country

Australia

Phone

+61 439769123

Fax

jacintabrinsley@hotmail.com

Contact person for public queries

Name

Jacinta Brinsley

Address

University of South Australia
P2-42, City East Campus
GPO Box 2471
Adelaide SA 5001

Country

Australia

Phone

+61 439769123

Fax

jacintabrinsley@hotmail.com

Contact person for scientific queries

Name

Jacinta Brinsley

Address

University of South Australia
P2-42, City East Campus
GPO Box 2471
Adelaide SA 5001

Country

Australia

Phone

+61 439769123

Fax

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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
8409	Ethical approval					380134-(Uploaded-05-08-2020-07-31-17)-Study-related document.pdf
8410	Informed consent form					380134-(Uploaded-07-07-2020-11-26-22)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Acute mood and cardiovascular responses to moderate intensity vinyasa yoga, static yin yoga and aerobic exercise in people with depression and/or anxiety disorders: A 5-arm randomised controlled trial.	2022	https://dx.doi.org/10.1016/j.mhpa.2022.100450

N.B. These documents automatically identified may not have been verified by the study sponsor.

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