ANZCTR - Registration

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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]

Nil Known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Depression

Anxiety

Condition category

Condition code

Mental Health

Depression

Mental Health

Anxiety

Alternative and Complementary Medicine

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]

Lifestyle

Intervention code [2]

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]

Depression Anxiety Stress Scale - 21 item (DASS-21)

Timepoint [1]

Baseline and six weeks

Secondary outcome [1]

Psychological distress - Kessler Psychological Distress Scale (K10)

Timepoint [1]

Baseline and six weeks

Secondary outcome [2]

Psychological well-being - Scale of Positive and Negative Experience (SPANE)

Timepoint [2]

Baseline and six weeks

Secondary outcome [3]

Psychological well-being - Flourishing Scale (FS)

Timepoint [3]

Baseline and six weeks

Secondary outcome [4]

Resilience - Connor-Davidson Resilience Scale (CD-RISC 2)

Timepoint [4]

Baseline and six weeks

Secondary outcome [5]

Self-reported Health Activities Questionnaire (HAQ)

Timepoint [5]

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

Sex

Both males and females

Can healthy volunteers participate?

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

12/08/2019

Actual

Date of last participant enrolment

Anticipated

15/11/2019

Actual

Date of last data collection

Anticipated

31/12/2019

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

University

Name [1]

NICM Health Research Institute, Western Sydney University

Address [1]

158-160 Hawkesbury Rd
WESTMEAD NSW 2145

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Western Sydney University HREC

Ethics committee address [1]

Locked Bag 1797
PENRITH NSW 2751

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/09/2018

Approval date [1]

12/03/2019

Ethics approval number [1]

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

Dr Michael de Manincor

Address

NICM Health Research Institute
Building J
Western Sydney University
Westmead Campus
158-160 Hawkesbury Rd
Westmead NSW 2145

Country

Australia

Phone

+61 2 9685 4700

Fax

[email protected]

Contact person for public queries

Name

Michael de Manincor

Address

NICM Health Research Institute
Building J
Western Sydney University
Westmead Campus
158-160 Hawkesbury Rd
Westmead NSW 2145

Country

Australia

Phone

+61 4 5691 6139

Fax

[email protected]

Contact person for scientific queries

Name

Michael de Manincor

Address

NICM Health Research Institute
Building J
Western Sydney University
Westmead Campus
158-160 Hawkesbury Rd
Westmead NSW 2145

Country

Australia

Phone

+61 2 9685 4700

Fax

[email protected]

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?

Doc. No.	Type	Email
3447	Study protocol	[email protected]
3450	Clinical study report	[email protected]
3451	Ethical approval	[email protected]

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.

Trial Review

Documents added manually

Documents added automatically