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Trial registered on ANZCTR


Registration number
ACTRN12619001073190
Ethics application status
Approved
Date submitted
25/07/2019
Date registered
5/08/2019
Date last updated
5/08/2019
Date data sharing statement initially provided
5/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Study of yoga interventions for reducing depression and anxiety
Scientific title
A randomised comparative mixed methods pilot study of yoga interventions for reducing depression and anxiety
Secondary ID [1] 298867 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 313783 0
Anxiety 313784 0
Condition category
Condition code
Mental Health 312185 312185 0 0
Depression
Mental Health 312186 312186 0 0
Anxiety
Alternative and Complementary Medicine 312187 312187 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study includes a comparison 2 different yoga interventions:
Arm 1:
Group yoga classes: 6 x 1.25 hr classes, once a week, for 6 weeks

All yoga sessions to be delivered by qualified yoga teachers, with a minimum of 5 years teaching experience and specialised training or experience in working with people with mental health concerns.

Adherence will be monitored by attendance checklist.

All yoga sessions are conducted at the NICM premises, Western Sydney University, Westmead Campus, 158-160 Hawkesbury Rd, Westmead.
Intervention code [1] 315095 0
Lifestyle
Intervention code [2] 315096 0
Treatment: Other
Comparator / control treatment
Arm 2 comparison:
One-on-one individual yoga sessions: 4 x 1 hr individual sessions, by appointment over 6 week period, with a personalised yoga practice to do at home:

Adherence will be monitored by attendance checklist, and completion of a yoga practice report form.

All yoga sessions to be delivered by qualified yoga teachers, with a minimum of 5 years teaching experience and specialised training or experience in working with people with mental health concerns.

All yoga sessions are conducted at the NICM premises, Western Sydney University, Westmead Campus, 158-160 Hawkesbury Rd, Westmead.
Control group
Active

Outcomes
Primary outcome [1] 320818 0
Depression Anxiety Stress Scale - 21 item (DASS-21)
Timepoint [1] 320818 0
Baseline and six weeks
Secondary outcome [1] 372949 0
Psychological distress - Kessler Psychological Distress Scale (K10)
Timepoint [1] 372949 0
Baseline and six weeks
Secondary outcome [2] 372950 0
Psychological well-being - Scale of Positive and Negative Experience (SPANE)
Timepoint [2] 372950 0
Baseline and six weeks
Secondary outcome [3] 372951 0
Psychological well-being - Flourishing Scale (FS)
Timepoint [3] 372951 0
Baseline and six weeks
Secondary outcome [4] 372952 0
Resilience - Connor-Davidson Resilience Scale (CD-RISC 2)
Timepoint [4] 372952 0
Baseline and six weeks
Secondary outcome [5] 372953 0
Self-reported Health Activities Questionnaire (HAQ)
Timepoint [5] 372953 0
Baseline and six weeks

Eligibility
Key inclusion criteria
Aged 18-65 years, inclusive; DASS-21 scores demonstrating at least mild severity of depression or anxiety (i.e. depression score above 10; or anxiety score above 8); adequate general health and ability to be involved in the yoga program; medication (including herbal medications, such as St John’s wort) and professional mental health assistance being unchanged for 3 months.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Serious injury or physical ailment (which yoga may negatively exacerbate), medical or psychological disorder likely to preclude completion of the trial; frequent alcohol or recreation intervention use; or have been undertaking yoga classes or a personal yoga practice, an average of more than once a week, over the past 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 randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Baseline demographics will be reported using descriptive statistics.
As this is a pilot study, between group differences will not be assessed directly.
Changes in each group’s baseline to endpoint data will be summarised and compared using means and 95% confidence intervals, providing estimated effect sizes. These will be compared to effect sizes found in prior studies of yoga for depression and anxiety (group and individual intervention approaches.

Recruitment
Recruitment status
Not yet 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)
NSW

Funding & Sponsors
Funding source category [1] 303379 0
University
Name [1] 303379 0
NICM Health Research Institute, Western Sydney University
Address [1] 303379 0
158-160 Hawkesbury Rd
WESTMEAD NSW 2145
Country [1] 303379 0
Australia
Primary sponsor type
University
Name
NICM Health Research Institute, Western Sydney University
Address
158-160 Hawkesbury Rd
WESTMEAD NSW 2145
Country
Australia
Secondary sponsor category [1] 303413 0
None
Name [1] 303413 0
Address [1] 303413 0
Country [1] 303413 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303911 0
Western Sydney University HREC
Ethics committee address [1] 303911 0
Locked Bag 1797
PENRITH NSW 2751
Ethics committee country [1] 303911 0
Australia
Date submitted for ethics approval [1] 303911 0
19/09/2018
Approval date [1] 303911 0
12/03/2019
Ethics approval number [1] 303911 0
H12929

Summary
Brief summary
This randomised controlled mixed methods pilot study aims to 1) compare the relative effectiveness of individualised yoga compared group yoga interventions for reducing depression and anxiety, and 2) to examine how the effectiveness of these two different intervention modalities may be influenced by patient preference.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95218 0
Dr Michael de Manincor
Address 95218 0
NICM Health Research Institute
Building J
Western Sydney University
Westmead Campus
158-160 Hawkesbury Rd
Westmead NSW 2145
Country 95218 0
Australia
Phone 95218 0
+61 2 9685 4700
Fax 95218 0
Email 95218 0
m.demanincor@westernsydney.edu.au
Contact person for public queries
Name 95219 0
Dr Michael de Manincor
Address 95219 0
NICM Health Research Institute
Building J
Western Sydney University
Westmead Campus
158-160 Hawkesbury Rd
Westmead NSW 2145
Country 95219 0
Australia
Phone 95219 0
+61 4 5691 6139
Fax 95219 0
Email 95219 0
m.demanincor@westernsydney.edu.au
Contact person for scientific queries
Name 95220 0
Dr Michael de Manincor
Address 95220 0
NICM Health Research Institute
Building J
Western Sydney University
Westmead Campus
158-160 Hawkesbury Rd
Westmead NSW 2145
Country 95220 0
Australia
Phone 95220 0
+61 2 9685 4700
Fax 95220 0
Email 95220 0
m.demanincor@westernsydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
This is a pilot study.
Data to be shared includes group allocation, de-identified demographic information, test measures, adverse events.
When will data be available (start and end dates)?
3 months after final analyses, no end date determined
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
any purpose
How or where can data be obtained?
by contacting Principal Investigator
What supporting documents are/will be available?
Study protocol
Clinical study report
Ethical approval
How or where can supporting documents be obtained?
Type [1] 3447 0
Study protocol
Citation [1] 3447 0
Link [1] 3447 0
Email [1] 3447 0
m.demanincor@westernsydney.edu.au
Other [1] 3447 0
Attachment [1] 3447 0
Type [2] 3450 0
Clinical study report
Citation [2] 3450 0
Link [2] 3450 0
Email [2] 3450 0
m.demanincor@westernsydney.edu.au
Other [2] 3450 0
Attachment [2] 3450 0
Type [3] 3451 0
Ethical approval
Citation [3] 3451 0
Link [3] 3451 0
Email [3] 3451 0
m.demanincor@westernsydney.edu.au
Other [3] 3451 0
Attachment [3] 3451 0
Summary results
No Results