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Trial registered on ANZCTR


Registration number
ACTRN12618001814268
Ethics application status
Approved
Date submitted
2/11/2018
Date registered
7/11/2018
Date last updated
18/05/2021
Date data sharing statement initially provided
7/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Self-Compassion, Guided-Imagery and Body Image in Women
Scientific title
The Impact of Self-Compassion and Guided-Imagery Podcasts on Body Image in Women: A Randomised Controlled Trial
Secondary ID [1] 296499 0
Nil known
Universal Trial Number (UTN)
U1111-1223-1948
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Body Image Disturbances 310282 0
Condition category
Condition code
Mental Health 309019 309019 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The research setting is online, with the pre-post questionnaires administered via Survey Monkey. The podcasts are also online and will be sent out via email to participants.
The research design will be a randomised controlled trial that will run over a one-week duration. Participants will be randomly allocated into two groups, the intervention group and an active control group. Each podcast runs from approximately 20 minutes. The study will be administered by a student studying an honours program in psychology under the supervision of an academic with a PhD in psychology.

Participants will then complete these steps as follows.
1. Initial online questionnaire measuring baseline levels of self-compassion, body appreciation and body shame. Participants email addresses will also be collected.
2. Intervention group: listen to the self-compassion podcast ‘Compassionate Body Scan’ and will answer questions about the podcast.
3. Intervention group: emailed link of the ‘Compassionate Body Scan’ and encouraged to listen to this podcast as many times as they like over the next three days.
4. Intervention group: emailed (with the same instructions) the ‘Loving Kindness’ podcast on day four of the experiment. The finale questionnaire will be sent on day seven of the experiment, measuring post-test levels of self-compassion, body appreciation, body shame and appearance contingent on self-worth.

The active control condition will be identical except participants will receive a guided imagery podcast (The Meadow and Sunrise on the Beach). Each podcast will be embedded in an online survey with questions to ensure participants engaged with the podcasts. Participants in the active control will also be sent the final questionnaire.
Intervention code [1] 312819 0
Prevention
Comparator / control treatment
An active control will be used in the study. Those randomised into the active control group will engage in guided- imagery meditation podcasts over a one week period.
Control group
Active

Outcomes
Primary outcome [1] 307974 0
A change in self-compassion measured using the Self-Compassion Scale.
Timepoint [1] 307974 0
At pre-test and then 7 days post commencement of the intervention.
Secondary outcome [1] 353544 0
A change in body appreciation as measured by the Body Appreciation Scale-2.
Timepoint [1] 353544 0
At pre-test and then 7 days post commencement of the intervention.
Secondary outcome [2] 353545 0
Change in body shame as measured by the Objectified Body Consciousness-Body Shame Subscale
Timepoint [2] 353545 0
At pre-test and then 7 days post commencement of the intervention.
Secondary outcome [3] 353546 0
A change in contingent self-worth based on appearance as measured by the Contingencies of Self-Worth Scale- Appearance Sub-scale.
Timepoint [3] 353546 0
At pre-test and then 7 days post commencement of the intervention.

Eligibility
Key inclusion criteria
Women aged 17-35 years with Internet access. Participants fluent in English language.
Minimum age
17 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not applicable

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence is automatically generated by Survey Monkey software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Mixed Design ANOVA, examining effects of group (intervention, active control) by time (pre-test and post-test) interaction on dependant variable mean scores.
Planned contrasts between pre and post-test for the intervention group.

The minimum sample size sought will be 68 based on a medium effect size of d=.5, alpha level of .05, and a power level of .8 calculated through GPOWER.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/11/2018
Actual
16/11/2018
Date of last participant enrolment
Anticipated
1/06/2019
Actual
30/04/2019
Date of last data collection
Anticipated
7/06/2019
Actual
4/05/2019
Sample size
Target
68
Accrual to date
Final
69
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 301089 0
University
Name [1] 301089 0
University of the Sunshine Coast
Country [1] 301089 0
Australia
Primary sponsor type
Individual
Name
Dr Ben Lane
Address
Locked Bag 4, Maroochydore DC 4558 QLD
University of the Sunshine Coast
Country
Australia
Secondary sponsor category [1] 300697 0
Individual
Name [1] 300697 0
Amy de Wet
Address [1] 300697 0
Locked Bag 4, Maroochydore DC 4558 QLD
University of the Sunshine Coast
Country [1] 300697 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301837 0
The University of the Sunshine Coast Human Research Ethics Committee
Ethics committee address [1] 301837 0
Ethics committee country [1] 301837 0
Australia
Date submitted for ethics approval [1] 301837 0
02/10/2018
Approval date [1] 301837 0
18/10/2018
Ethics approval number [1] 301837 0
S181234

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

Contacts
Principal investigator
Name 88278 0
Dr Ben Lane
Address 88278 0
The University of the Sunshine Coast Locked Bag 4 Maroochydore DC 4558 QLD
Country 88278 0
Australia
Phone 88278 0
+61 754594585
Fax 88278 0
Email 88278 0
blane@usc.edu.au
Contact person for public queries
Name 88279 0
Amy de Wet
Address 88279 0
The University of the Sunshine Coast Locked Bag 4 Maroochydore DC 4558 QLD
Country 88279 0
Australia
Phone 88279 0
+61 754594585
Fax 88279 0
Email 88279 0
a_d088@student.usc.edu.au
Contact person for scientific queries
Name 88280 0
Ben Lane
Address 88280 0
The University of the Sunshine Coast Locked Bag 4 Maroochydore DC 4558 QLD
Country 88280 0
Australia
Phone 88280 0
+61 754594585
Fax 88280 0
Email 88280 0
blane@usc.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The research data will include confidential data pertaining to the participants.


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.