Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001028897
Ethics application status
Approved
Date submitted
1/07/2021
Date registered
5/08/2021
Date last updated
18/07/2022
Date data sharing statement initially provided
5/08/2021
Date results provided
18/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Mind, Body, and Well-being in Young Men and Women: Exploring the Efficacy of a Brief Meditation Intervention
Scientific title
Mind, Body, and Well-being in Healthy Young Men and Women: Exploring the Efficacy of a Brief Meditation Intervention
Secondary ID [1] 304613 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Body dissatisfaction 322532 0
Psychological wellbeing 322533 0
Condition category
Condition code
Mental Health 320161 320161 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Summary: This study involves a 3-week intervention period during which participants will listen to audio recordings of brief self-compassion meditations each day. Pre- and post-intervention measures of body dissatisfaction, body appreciation, and psychological wellbeing will be administered via an online survey, and these measures will be administered again 6 weeks after the intervention. The purpose of the study is to investigate whether regular listening to self-compassion meditations decreases body dissatisfaction, increases body appreciation, and improves psychological wellbeing.
Brief name: Self-compassion meditation
Materials: All audio recordings of the self-compassion meditations are freely available at www.self-compassion.org. The specific meditations are: Week 1, Compassionate Body Scan (24 minutes); Week 2, Affectionate Breathing (21 minutes); Week 3: Loving Kindness (20 minutes).
Procedures: Participants randomly allocated to the intervention group following the pre-intervention online survey will be given a commencement date for the intervention period. They will be provided the links to the relevant meditations via email and text reminders each day during the intervention period, and will be asked to listen to the relevant meditation each day.
Who: The research team will send the email and text reminders. The meditation recordings were made by Dr Kristen Neff, a leading expert in self-compassion. It will be up to participants to access and listen to these recordings.
Mode of delivery: Participants will access the recordings online.
Duration and intensity: Participants will listen to the relevant meditation recordings (approximately 20 minutes) once a day for three weeks.
Location: All participants will complete online surveys and listen to audio recordings of the meditations at a location of their choosing, provided they have internet access.
Adherence and fidelity: Participants will receive daily reminders via email and text to access and listen to the recordings. As the recordings are provided by a third party, we will not be able to track adherence. However, in the post-intervention survey we will ask participants to report how often they listened to the recordings.
Intervention code [1] 321032 0
Behaviour
Intervention code [2] 321192 0
Treatment: Other
Comparator / control treatment
A multiple baseline design will be adopted whereby a control group will complete the pre- and post-intervention surveys at the same times as the intervention group. During the intervention period, the control group will not be exposed to the intervention and will be requested not to do anything they would not normally do. However, following the main intervention period and the post-intervention survey, those in the control group will then undergo the same intervention, as it is our ethical responsibility to provide access to the intervention to all participants involved in the study. The control group will commence the intervention immediately after the main intervention group completes the intervention (i.e., 3 weeks after the commencement of the main intervention group). Participants will not be told which group they are in; they will simply be given different commencement dates.
Control group
Active

Outcomes
Primary outcome [1] 328123 0
Change in body appreciation scores as determined by the Body Appreciation-2 Scale (BAS-2; Tylka & Wood-Barcalow, 2015)
Timepoint [1] 328123 0
(1) Baseline, (2) 3 weeks post-intervention commencement (primary endpoint), (3) 6 weeks post-intervention completion (i.e., 9 weeks following intervention commencement).
Primary outcome [2] 328124 0
Changes in body dissatisfaction levels as determined by the Body Shape Questionnaire (BSQ; Cooper et al. 1987).
Timepoint [2] 328124 0
(1) Baseline, (2) 3 weeks post-intervention commencement (primary endpoint), (3) 6 weeks post-intervention completion (i.e., 9 weeks following intervention commencement).
Secondary outcome [1] 397725 0
Changes in psychological wellbeing as determined by the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS; Tennant et al., 2007)
Timepoint [1] 397725 0
(1) Baseline, (2) 3 weeks post-intervention commencement, (3) 6 weeks post-intervention completion (i.e., 9 weeks following intervention commencement).
Secondary outcome [2] 397726 0
Changes in self-compassion levels as determined by the Self-Compassion Scale (SCS; Neff, 2003).
Timepoint [2] 397726 0
(1) Baseline, (2) 3 weeks post-intervention commencement, (3) 6 weeks post-intervention completion (i.e., 9 weeks following intervention commencement).

Eligibility
Key inclusion criteria
Participants will be young adults in the Australian general population
Minimum age
18 Years
Maximum age
39 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals with a formal diagnosis of an eating disorder and/or an anxiety disorder are ineligible. The pre-intervention survey will also screen for eating disorder symptoms using the Eating Disorder Examination Questionnaire Short (EDE-QS; Gideon et al., 2016), and anxiety symptoms using the Anxiety subscale of the Depression, Anxiety, and Stress Scale short form (DASS-21; Lovibond & Lovibond, 1995). EDE scores above 15 indicate the possible presence of an eating disorder, therefore individuals with a score above 15 will be excluded. Similarly, anxiety scores above 15 indicate severe or extremely severe anxiety, therefore individuals with scores above 15 will be excluded.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Other
Other design features
This study follows a multiple baseline design whereby all participants will receive the intervention but commence at different times. The main intervention group will receive it first, and the control group will receive it after the main intervention period. See below for further detail:
(a) Participants are randomly assigned to intervention or control group after registering in the study.
(b) All participants complete pre-intervention measures at the starting date.
(c) The intervention group undergoes the self-compassion meditation intervention for a 3 week period while the control group do not do anything they would not usually do.
(c) All participants complete post-intervention measures at the same time, 3 weeks after the commencement of the intervention period for the intervention group.
(d) The control group commences the intervention immediately after the intervention group are finished (i.e., 3 weeks after study commencement).
(e) The main intervention group ONLY complete follow-up measures 6 weeks after concluding their intervention (i.e., 9 weeks after study commencement).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A priori sample size estimation using the software G*Power Version 3.1.9.2, assuming at least an 80% chance of detecting a moderate anticipated between-groups effect size (f = .25) at an alpha level of 0.05, suggested that a total sample of N = 98 would be sufficient. The estimation of a small to moderate effect size was based on the effect sizes for mindfulness based intervention examinations reported in previous studies. We are aiming to acquire 120 participants, whilst taking into account an estimated attrition rate of 15% .
A mixed model analysis of variance will be used to assess differences in each of the outcome variables between the intervention and waitlist control groups over time.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/08/2021
Actual
31/08/2021
Date of last participant enrolment
Anticipated
13/09/2021
Actual
1/10/2021
Date of last data collection
Anticipated
15/11/2021
Actual
15/12/2021
Sample size
Target
120
Accrual to date
Final
147
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 308975 0
University
Name [1] 308975 0
Victoria University
Country [1] 308975 0
Australia
Primary sponsor type
University
Name
Victoria University
Address
Ballarat Rd, Footscray VIC 3010
PO Box 14428, Melbourne VIC 8001
Country
Australia
Secondary sponsor category [1] 309909 0
None
Name [1] 309909 0
Address [1] 309909 0
Country [1] 309909 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308867 0
Victoria University Human Research Ethics Committee
Ethics committee address [1] 308867 0
Ethics committee country [1] 308867 0
Australia
Date submitted for ethics approval [1] 308867 0
30/03/2021
Approval date [1] 308867 0
17/08/2021
Ethics approval number [1] 308867 0
HRE21-028

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112158 0
Dr Warwick Hosking
Address 112158 0
Victoria University (Footscray Park campus)
PO Box 14428
Melbourne VIC 8001
Country 112158 0
Australia
Phone 112158 0
+61391992620
Fax 112158 0
Email 112158 0
[email protected]
Contact person for public queries
Name 112159 0
Warwick Hosking
Address 112159 0
Victoria University (Footscray Park campus)
PO Box 14428
Melbourne VIC 8001
Country 112159 0
Australia
Phone 112159 0
+61391992620
Fax 112159 0
Email 112159 0
[email protected]
Contact person for scientific queries
Name 112160 0
Warwick Hosking
Address 112160 0
Victoria University (Footscray Park campus)
PO Box 14428
Melbourne VIC 8001
Country 112160 0
Australia
Phone 112160 0
+61391992620
Fax 112160 0
Email 112160 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We are advising participants that their responses will be kept confidential. We may provide de-identified data to journals if they request it for replicating our analyses, but we will not make the data publicly available.


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.