Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000612415
Ethics application status
Approved
Date submitted
6/05/2016
Date registered
11/05/2016
Date last updated
27/10/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Yoga for Stress Study
Scientific title
The effect of a Hatha Yoga practice on factors related to chronic stress in middle-aged women reporting psychological distress
Secondary ID [1] 289151 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic stress and psychological distress 298678 0
Immunity (inflammation) 298679 0
Condition category
Condition code
Mental Health 298733 298733 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Yoga Intervention conducted by certified yoga instructor (Yoga Australia, Level 2) with 7 years teaching experience. Classes were conducted at a centrally located community centre (public transport and ample parking is available nearby).Composed of 8 weeks of twice-weekly hour long yoga classes (16 classes total), which follow the structure listed below. Classes were scheduled for Monday and Friday evenings and participants were assigned to a flexible 1730-1830 or 1900-2000 timeslot (the maximum class-size feasible = 30 participants).

1) Active mindfulness mediation
2) Warm-up postures on floor
3) Sun Salutations (series of postures that 'flow together')
4) Standing postures
5) Floor postures
6) Savasana (lying down, relaxation)

Prior to class participants were asked to complete a self-reported check-list of attendance, this was confirmed by instructor's observation/headcount. Additionally, participants completed the Positive and Negative Affect Schedule (PANAS) before and after each class.
Intervention code [1] 294672 0
Other interventions
Comparator / control treatment
Randomised, stratified by level of distress, wait-list-controlled (received the yoga intervention 12 weeks after the intervention group).
Control group
Active

Outcomes
Primary outcome [1] 298209 0
Kessler Psychological Distress Scale (K10) (Kessler & Mroczeck, 1994)
Timepoint [1] 298209 0
Baseline, Post-Intervention, 1-month follow-up, and at wait-list control group's post-intervention
Primary outcome [2] 298210 0
Perceived Stress Scale (PSS) (Cohen, Kamarck, & Mermelstein, 1983)
Timepoint [2] 298210 0
Baseline, Post-Intervention, 1-month follow-up, and at wait-list control group's post-intervention
Primary outcome [3] 298211 0
Emotional based mood-states assessed using the Positive and Negative Affect Schedule (PANAS) (Watson, Clark, & Tellegen, 1988)
Timepoint [3] 298211 0
Baseline, Post-Intervention, 1-month follow-up, and at wait-list control group's post-intervention; additionally, pre- and post-yoga class measures at each of the 16 classes administered
Secondary outcome [1] 323537 0
The Personal Wellbeing Index- Adult (PWI-A)(International Wellbeing Group, 2006)
Timepoint [1] 323537 0
Baseline, Post-Intervention, 1-month follow-up, and at wait-list control group's post-intervention
Secondary outcome [2] 323538 0
The Mindfulness Attention Awareness Scale (MASS) (Brown & Ryan, 2003)
Timepoint [2] 323538 0
Baseline, Post-Intervention, 1-month follow-up, and at wait-list control group's post-intervention
Secondary outcome [3] 323539 0
The International Physical Activity Questionnaire (IPAQ) (Craig et al., 2003)
Timepoint [3] 323539 0
Baseline, Post-Intervention, 1-month follow-up, and at wait-list control group's post-intervention
Secondary outcome [4] 323540 0
Motives for Physical Activity Measure - Revised (MPAM-R)
Timepoint [4] 323540 0
Baseline, Post-Intervention, 1-month follow-up, and at wait-list control group's post-intervention
Secondary outcome [5] 323541 0
State Trait Anger Expression Inventory-2 (STAI-2) (Spielberger, 1999)
Timepoint [5] 323541 0
Baseline, Post-Intervention, 1-month follow-up, and at wait-list control group's post-intervention
Secondary outcome [6] 323542 0
UCLA Loneliness Scale (Russell, 1996)
Timepoint [6] 323542 0
Baseline, Post-Intervention, 1-month follow-up, and at wait-list control group's post-intervention
Secondary outcome [7] 323543 0
Revised Helping Alliance Questionnaire (HAq-II) that is modified to assesses the extent to which the participant experiences their yoga instructor as helpful
Timepoint [7] 323543 0
Mid-point of Intervention (after the 8th yoga session) and Post-Intervention (after the 16th yoga session)
Secondary outcome [8] 323544 0
A Course Satisfaction Questionnaire, that asks questions about participant’s satisfaction with the yoga classes
Timepoint [8] 323544 0
Mid-point of Intervention (after the 8th yoga session) and Post-Intervention (after the 16th yoga session)
Secondary outcome [9] 323545 0
Heart Rate as measured by OMRON HEM-7203
Timepoint [9] 323545 0
Baseline, Post-Intervention, 1-month follow-up, and at wait-list control group's post-intervention
Secondary outcome [10] 323546 0
Blood Pressure as measured by OMRON HEM-7203
Timepoint [10] 323546 0
Baseline, Post-Intervention, 1-month follow-up, and at wait-list control group's post-intervention
Secondary outcome [11] 323547 0
“Sit-and-reach” test, which is a measure of flexibility (Lopez-Minarro, Muyor, & Alacid, 2011)
Timepoint [11] 323547 0
Baseline, Post-Intervention, 1-month follow-up, and at wait-list control group's post-intervention
Secondary outcome [12] 323548 0
high sensitivity C-reactive protein (hsCRP) as measured by serum assay (assessed in a subset of 35 participants)
Timepoint [12] 323548 0
Baseline, Post-Intervention, 1-month follow-up, and at wait-list control group's post-intervention
Secondary outcome [13] 323549 0
Inflammatory cytokines (Tumor necrosis factor alpha [TNFa], Interleukin 6 [IL-6]) as measured by serum assay (assessed in a subset of 35 participants)
Timepoint [13] 323549 0
Baseline, Post-Intervention, 1-month follow-up, and at wait-list control group's post-intervention
Secondary outcome [14] 323550 0
Deoxyribonucleic acid (DNA) methylation measured in wholebloods (assessed in a subset of 28 participants). QIAamp DNA Mini Kit (QIAGEN) was used to extract DNA, and bisulphite-converted using MethylEasyTM Xceed Kit (Genetic Signatures, Darlinghurst, Australia)
Timepoint [14] 323550 0
Post-Intervention, 1-month follow-up, and at wait-list control group's post-intervention
Secondary outcome [15] 323551 0
Ribonucleic acid (RNA) gene expression will be measured in wholebloods (to be assessed in a subset of 28 participants)
Timepoint [15] 323551 0
Post-Intervention, 1-month follow-up, and at wait-list control group's post-intervention
Secondary outcome [16] 323553 0
Waist-to-Height Ratio (height was measured in cm using the lab's permanently secured tape-measure, and weight was measured in kg by a digital scale placed on a solid surface)
Timepoint [16] 323553 0
Baseline, Post-Intervention, 1-month follow-up, and at wait-list control group's post-intervention

Eligibility
Key inclusion criteria
1) Healthy and free from acute infections for at least two weeks prior to biochemical or psychological assessments as indicated by self-report.
2) Refrain from drinking alcohol in the last 48 hours prior to biochemical or psychological assessments.
3) Refrain from eating or drinking (other than water) for 12 hours prior to biochemical or psychological assessments.
4) Kessler Psychological Distress Scale (K10) score of 16+, for at least one month (Kessler & Mroczeck, 1994)
5) Able to commit to attendance at 2 yoga classes a week for the duration of the intervention (8 weeks).
6) Able to provide own transportation to and from the assessment sessions at SA Pathology.
7) Agreement to withhold commencement of a yoga practice until after the follow up testing session, if allocated to the waitlist control.
Minimum age
35 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Anaemia
2) Diabetes
3) Cardiovascular diseases such as coronary heart disease
4) Blood cancers such as leukaemia and lymphoma
5) Inflammatory bowel diseases such as Crohn’s disease
6) Autoimmune diseases such as autoimmune thyroiditis and lupus, rheumatoid arthritis, pernicious anaemia
7) Asthma and being treated with steroids
8) Known immunodeficiency diseases such as HIV and infectious mononucleosis
9) Smoking
10) Alcoholism
11) On immune effecting medication
12) Serious psychological illness
13) Serious physiological illness
14) Presently practicing yoga, or having engaged in a regular yoga practice within the past year
15) Foreseeable acute stressors arising during the course of the intervention and follow-up period (e.g. university exams)

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)
Central randomisation (web-based) was used for allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants were stratified according to their K10 (psychological distress) score (Moderate, High or Very high). Then randomisation was conducted on the computer utilising Research Randomizer.

Urbaniak, G. C., & Plous, S. . (2013). Research Randomizer (Version 4.0) [Computer software] http://www.randomizer.org/. Retrieved April 10, 2013, from http://www.randomizer.org/
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
After completion of follow-up testing, the yoga intervention was administered to the waitlist-control group and post-test assessment was completed at conclusion.

All participants provided data for psychological (i.e. questionnaires) and physiological (e.g. blood-pressure, flexibility) outcomes (N = 116).

Biochemical markers of inflammation: Due to resource availability the achievability of a within-subjects, longitudinal design, random-effects modelling can be used, making it necessary to only take blood samples of a subset of the participants (n = 30). The study is designed to collect biochemical measures at three time points (pre, post, and follow-up), using all of these observations and time-varying covariates, the intra-patient variability of the biochemical measures will be decreased relative to a cross-sectional or a between-subjects experimental design, thus increasing the feasible statistical power.

Pilot genetic factors study: the addition of genetic factors to this study came following the baseline time-point, thus data (n = 28) was collected at the following time points: post-test, follow-up, and follow-up after the waitlist control's yoga intervention. Thus this small pilot study will conduct a cross-sectional analysis at post-test (yoga intervention completer vs control) and longitudinal analysis on the control group.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A power analysis (0.80) conducted (repeated measures, between factors ANOVA, p = .05) shows that for the RCT a total of 86 participants for the two groups will be required for this study to obtain a medium effect size (f = 0.25). Due to common drop-outs in exercise interventions, this study planned to obtain a minimum of 96 participants. This target insured power to find medium effects on psychological variables utilizing ANOVAs. Mixed-models will conducted, such testing can control for nesting and covariates (e.g. physical activity). Application of both analysis allows for more complex designs coupled with clear effect sizes.

The reliable change index (RC) and the clinically significant change index (CSC) will be applied to participant's in the yoga group to indicate if improvement or decline for an individual is greater than might be due to measurement error, and if the cut-off point for the participant’s score is within the normal range, rather than the clinical.

As the biochemical and genetic samples are smaller, mixed-models will be used when appropriate. Additionally ANOVA's and t-tests will be performed to corroborate findings (and derive effect sizes).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
14/03/2013
Date of last participant enrolment
Anticipated
Actual
12/04/2013
Date of last data collection
Anticipated
Actual
30/06/2014
Sample size
Target
96
Accrual to date
Final
116
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 13220 0
5005 - The University Of Adelaide

Funding & Sponsors
Funding source category [1] 293536 0
University
Name [1] 293536 0
The University of Adelaide
Country [1] 293536 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
The School of Psychology
The University of Adelaide
Adelaide SA, 5005
Country
Australia
Secondary sponsor category [1] 292353 0
None
Name [1] 292353 0
Address [1] 292353 0
Country [1] 292353 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294981 0
The University of Adelaide Human Research Ethics Committee
Ethics committee address [1] 294981 0
Ethics committee country [1] 294981 0
Australia
Date submitted for ethics approval [1] 294981 0
12/12/2012
Approval date [1] 294981 0
27/02/2013
Ethics approval number [1] 294981 0
H-2013-001

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 870 870 0 0
/AnzctrAttachments/370651-H-2013-001.pdf
Attachments [2] 871 871 0 0
/AnzctrAttachments/370651-Outline of Yoga Session Structure.pdf

Contacts
Principal investigator
Name 65662 0
Prof Paul Delfabbro
Address 65662 0
The School of Psychology
The University of Adelaide
Adelaide SA 5005
Country 65662 0
Australia
Phone 65662 0
+61 8 831 34936
Fax 65662 0
Email 65662 0
[email protected]
Contact person for public queries
Name 65663 0
Kaitlin Harkess
Address 65663 0
The School of Psychology
The University of Adelaide
Adelaide SA 5005
Country 65663 0
Australia
Phone 65663 0
+61 8 8313 7402
Fax 65663 0
Email 65663 0
[email protected]
Contact person for scientific queries
Name 65664 0
Kaitlin Harkess
Address 65664 0
The School of Psychology
The University of Adelaide
Adelaide SA 5005
Country 65664 0
Australia
Phone 65664 0
+61 8 8313 7402
Fax 65664 0
Email 65664 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbasePreliminary indications of the effect of a brief yoga intervention on markers of inflammation and DNA methylation in chronically stressed women.2016https://dx.doi.org/10.1038/tp.2016.234
N.B. These documents automatically identified may not have been verified by the study sponsor.