Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000178741
Ethics application status
Approved
Date submitted
12/02/2013
Date registered
13/02/2013
Date last updated
18/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial of yoga for reducing depression and anxiety, and improving well-being and mental health.
Scientific title
Randomised controlled trial comparing benefits of personalised yoga interventions with waitlist treatment as usual, for reducing symptoms of depression and anxiety, and improving positive emotions, well-being and mental health.
Secondary ID [1] 281941 0
None
Universal Trial Number (UTN)
U1111-1139-4713
Trial acronym
Yoga for Mental Health (Y-MH)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 288350 0
Anxiety 288351 0
Condition category
Condition code
Mental Health 288701 288701 0 0
Depression
Mental Health 288702 288702 0 0
Anxiety
Alternative and Complementary Medicine 288703 288703 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
4 x 1 hour private yoga sessions are offered to each participant, over period of six weeks. A suitable personalised yoga practice is developed for participants to do at home, using consensus-based yoga protocol guidelines.
Intervention code [1] 286503 0
Other interventions
Comparator / control treatment
6 week waitlist period, with treatment as usual (TAU).
Yoga intervention is offered at end of waitlist period.
Control group
Active

Outcomes
Primary outcome [1] 288845 0
Depression, Anxiety and Stress Scale (DASS-21)
Timepoint [1] 288845 0
Baseline, after 6 week intervention period, and 12 week follow-up (6 weeks after intervention completion)
Secondary outcome [1] 301130 0
Kessler Psychological Distress Scale (K10)
Timepoint [1] 301130 0
Baseline, after 6 week intervention period, and 12 week follow-up (6 weeks after intervention completion)
Secondary outcome [2] 301131 0
Short-Form Health Survey (SF-12v2)
Timepoint [2] 301131 0
Baseline, after 6 week intervention period, and 12 week follow-up (6 weeks after intervention completion)
Secondary outcome [3] 301132 0
Scale of Positive and Negative Experience (SPANE)
Timepoint [3] 301132 0
Baseline, after 6 week intervention period, and 12 week follow-up (6 weeks after intervention completion)
Secondary outcome [4] 301133 0
Flourishing Scale (FS)
Timepoint [4] 301133 0
Baseline, after 6 week intervention period, and 12 week follow-up (6 weeks after intervention completion)
Secondary outcome [5] 301134 0
Connor-Davidson Resilience Scale 2 (CD-RISC 2)
Timepoint [5] 301134 0
Baseline, after 6 week intervention period, and 12 week follow-up (6 weeks after intervention completion)
Secondary outcome [6] 301138 0
Credibility-Expectancy Questionnaire (CEQ) used as a predictor of outcome, not an outcome measure.
Timepoint [6] 301138 0
Baseline only

Eligibility
Key inclusion criteria
Mild or moderate depression or anxiety indicated by DASS score, English competency, anti-depressant/anxiety medications (including complementary) and other forms of professional assistance are stable for at least 3 months.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Serious medical conditions, injuries or surgeries; alcohol or drug abuse; already doing a personal yoga practice (average of more than once a week, over the past 3 months.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2013
Actual
1/03/2013
Date of last participant enrolment
Anticipated
Actual
15/09/2014
Date of last data collection
Anticipated
Actual
15/12/2014
Sample size
Target
120
Accrual to date
Final
108
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 286721 0
University
Name [1] 286721 0
NICM Health Research Institute
Country [1] 286721 0
Australia
Primary sponsor type
University
Name
Centre for Complementary Medicine Research, University of Western Sydney
Address
Locked Bag 1797
Penrith NSW 2751
Country
Australia
Secondary sponsor category [1] 285494 0
None
Name [1] 285494 0
Address [1] 285494 0
Country [1] 285494 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288793 0
UWS HREC
Ethics committee address [1] 288793 0
University of Western Sydney
Office of Research Services
Locked Bag 1797
Penrith NSW 2751
Ethics committee country [1] 288793 0
Australia
Date submitted for ethics approval [1] 288793 0
Approval date [1] 288793 0
02/07/2012
Ethics approval number [1] 288793 0
H9529

Summary
Brief summary
This study aims to investigate the benefits of yoga in the reduction of depression and anxiety, and associated increases in positive emotions, well-being and mental health.
Trial website
Trial related presentations / publications
de Manincor et al, DEPRESSION AND ANXIETY 33:816–828 (2016)
DOI 10.1002/da.22502
Public notes

Contacts
Principal investigator
Name 37786 0
Mr Michael de Manincor
Address 37786 0
Centre for Complementary Medicine Research
University of Western Sydney
Locked Bag 1797
Penrith NSW 2751
Country 37786 0
Australia
Phone 37786 0
+61 4 04587643 or +61 2 46203695
Fax 37786 0
Email 37786 0
m.demanincor@uws.edu.au
Contact person for public queries
Name 37787 0
Michael de Manincor
Address 37787 0
Centre for Complementary Medicine Research
University of Western Sydney
Locked Bag 1797
Penrith NSW 2751
Country 37787 0
Australia
Phone 37787 0
+61 4 04587643 or +61 2 46203695
Fax 37787 0
Email 37787 0
m.demanincor@uws.edu.au
Contact person for scientific queries
Name 37788 0
Alan Bensoussan
Address 37788 0
Centre for Complementary Medicine Research
University of Western Sydney
Locked Bag 1797
Penrith NSW 2751
Country 37788 0
Australia
Phone 37788 0
+61 2 4620 3284
Fax 37788 0
Email 37788 0
a.bensoussan@uws.edu.au

No information has been provided regarding IPD availability


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.