Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Date results information initially provided
18/05/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Self-Compassion, Guided-Imagery and Body Image in Women
Query!
Scientific title
The Impact of Self-Compassion and Guided-Imagery Podcasts on Body Image in Women: A Randomised Controlled Trial
Query!
Secondary ID [1]
296499
0
Nil known
Query!
Universal Trial Number (UTN)
U1111-1223-1948
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Body Image Disturbances
310282
0
Query!
Condition category
Condition code
Mental Health
309019
309019
0
0
Query!
Eating disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
312819
0
Prevention
Query!
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.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
307974
0
A change in self-compassion measured using the Self-Compassion Scale.
Query!
Assessment method [1]
307974
0
Query!
Timepoint [1]
307974
0
At pre-test and then 7 days post commencement of the intervention.
Query!
Secondary outcome [1]
353544
0
A change in body appreciation as measured by the Body Appreciation Scale-2.
Query!
Assessment method [1]
353544
0
Query!
Timepoint [1]
353544
0
At pre-test and then 7 days post commencement of the intervention.
Query!
Secondary outcome [2]
353545
0
Change in body shame as measured by the Objectified Body Consciousness-Body Shame Subscale
Query!
Assessment method [2]
353545
0
Query!
Timepoint [2]
353545
0
At pre-test and then 7 days post commencement of the intervention.
Query!
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.
Query!
Assessment method [3]
353546
0
Query!
Timepoint [3]
353546
0
At pre-test and then 7 days post commencement of the intervention.
Query!
Eligibility
Key inclusion criteria
Women aged 17-35 years with Internet access. Participants fluent in English language.
Query!
Minimum age
17
Years
Query!
Query!
Maximum age
35
Years
Query!
Query!
Sex
Females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
Not applicable
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer.
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence is automatically generated by Survey Monkey software.
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
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.
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
16/11/2018
Query!
Actual
16/11/2018
Query!
Date of last participant enrolment
Anticipated
1/06/2019
Query!
Actual
30/04/2019
Query!
Date of last data collection
Anticipated
7/06/2019
Query!
Actual
4/05/2019
Query!
Sample size
Target
68
Query!
Accrual to date
Query!
Final
69
Query!
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Query!
Funding & Sponsors
Funding source category [1]
301089
0
University
Query!
Name [1]
301089
0
University of the Sunshine Coast
Query!
Address [1]
301089
0
Locked Bag 4, Maroochydore DC 4558 QLD
Query!
Country [1]
301089
0
Australia
Query!
Primary sponsor type
Individual
Query!
Name
Dr Ben Lane
Query!
Address
Locked Bag 4, Maroochydore DC 4558 QLD
University of the Sunshine Coast
Query!
Country
Australia
Query!
Secondary sponsor category [1]
300697
0
Individual
Query!
Name [1]
300697
0
Amy de Wet
Query!
Address [1]
300697
0
Locked Bag 4, Maroochydore DC 4558 QLD
University of the Sunshine Coast
Query!
Country [1]
300697
0
Australia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
301837
0
The University of the Sunshine Coast Human Research Ethics Committee
Query!
Ethics committee address [1]
301837
0
Locked Bag 4, Maroochydore DC 4558 QLD
Query!
Ethics committee country [1]
301837
0
Australia
Query!
Date submitted for ethics approval [1]
301837
0
02/10/2018
Query!
Approval date [1]
301837
0
18/10/2018
Query!
Ethics approval number [1]
301837
0
S181234
Query!
Summary
Brief summary
Self-compassion interventions may be a promising new approach for addressing body image concerns. The aim of the study is to observe the impact of self-compassion meditation podcasts on increasing levels of self-compassion and body appreciation, as well as decreasing levels of body shame and appearance contingent on self-worth. Women aged 17 to 35 years will be randomised into two groups, and engage in either self-compassion or guided imagery podcasts over one week.
Query!
Trial website
https://www.surveymonkey.com/r/ISCGI
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
88278
0
Dr Ben Lane
Query!
Address
88278
0
The University of the Sunshine Coast Locked Bag 4 Maroochydore DC 4558 QLD
Query!
Country
88278
0
Australia
Query!
Phone
88278
0
+61 754594585
Query!
Fax
88278
0
Query!
Email
88278
0
[email protected]
Query!
Contact person for public queries
Name
88279
0
Miss Amy de Wet
Query!
Address
88279
0
The University of the Sunshine Coast Locked Bag 4 Maroochydore DC 4558 QLD
Query!
Country
88279
0
Australia
Query!
Phone
88279
0
+61 754594585
Query!
Fax
88279
0
Query!
Email
88279
0
[email protected]
Query!
Contact person for scientific queries
Name
88280
0
Dr Ben Lane
Query!
Address
88280
0
The University of the Sunshine Coast Locked Bag 4 Maroochydore DC 4558 QLD
Query!
Country
88280
0
Australia
Query!
Phone
88280
0
+61 754594585
Query!
Fax
88280
0
Query!
Email
88280
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
The research data will include confidential data pertaining to the participants.
Query!
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.
Download to PDF