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Trial registered on ANZCTR


Registration number
ACTRN12618002025213
Ethics application status
Approved
Date submitted
10/12/2018
Date registered
18/12/2018
Date last updated
18/12/2018
Date data sharing statement initially provided
18/12/2018
Date results information initially provided
18/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Enhancing self-compassion in individuals with visible skin conditions: Randomised Pilot of the "My Changed Body" Self-Compassion Writing Intervention
Scientific title
Enhancing self-compassion in individuals with visible skin conditions: Randomised Pilot of the "My Changed Body" Self-Compassion Writing Intervention
Secondary ID [1] 296832 0
N/A
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
visible skin condition 310734 0
Condition category
Condition code
Skin 309425 309425 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The My Changed Body intervention is a self-compassion focused writing exercise designed to enhance self-compassion through a series of 6 guided writing prompts. It has been developed for use in the breast cancer context and successfully trialled and published. Writers focus on an aspect of their body related to their skin condition that has led to a negative experience. The intervention entails undertaking a sequence of brief writing to view their skin condition negative body-related experience in a more self-compassionate light. The exercise entails approximately 30 minutes' duration of writing in an online environment. All participants must complete all writing exercises. Participants are able to complete the initial survey and writing exercise in a location of their choosing, as long as they have internet access. To progress through the study, participants needed to progress through the writing task. Any participants not choosing to complete the writing were able to withdraw from the study through their non-completion and by closing the browser.
An example of the writing prompts is:
Kindness to your body
Think about how your body has changed through your experience with a breast cancer diagnosis and treatment. Please write a paragraph about whether or not you have treated your body and yourself with kindness during this time.
Intervention code [1] 313116 0
Other interventions
Comparator / control treatment
Control group also undertook a 30 minute writing exercise, in this case expressive writing (unstructured) discussing their negative experience related to their body/skin condition. No specific prompts are provided other to request that they keep writing about their experience.
Control group
Active

Outcomes
Primary outcome [1] 308380 0
Self-compassion measured with the Self Compassion Scale - Short Form
Raes, F., Pommier, E., Neff, K. D., & Van Gucht, D. (2011). Construction and factorial validation of a short form of the Self-Compassion Scale. Clinical Psychology & Psychotherapy. 18, 250-255
Timepoint [1] 308380 0
Immediately after writing
Primary outcome [2] 308381 0
Negative Affect
Measured by the PANAS
Watson, Clark & Tellegen (1988)
Timepoint [2] 308381 0
Immediately after writing
Primary outcome [3] 308461 0
Positive Affect
Measured by the PANAS
Watson, Clark & Tellegen (1988)
Timepoint [3] 308461 0
Immediately after writing
Secondary outcome [1] 354816 0
No secondary outcomes
Timepoint [1] 354816 0
N/A

Eligibility
Key inclusion criteria
Individuals over 18 years who were experiencing a currently symptomatic and visible skin
condition (e.g., eczema, psoriasis, acne) and who had experienced at least one negative event
related to their skin condition (entailing feelings of failure, humiliation or rejection) were
eligible for this study.
All participants would need to complete an online English-language
writing activity; hence, internet access was a requirement.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Less than 18 years; no internet access

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)
The intervention was administered entirely online so randomisation occurred online. Participants were informed that they would all take part in a writing exercise. Concealment was by central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Qualtrics randomiser function was used to randomise participants following the completion of the online pre-survey.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Active control group using an expressive writing intervention, so that time and attention of writing can be taken into account.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Analyses were performed in SPSS v. 25.0 (IBM Corp., 2017) unless otherwise specified. Significance was set at 0.05 for all tests. Chi-square and t-test analyses were used to identify covariates (i.e., testing for significant differences across pre-allocation outcome measures and sample characteristics between condition allocation and recruitment source - students vs. community). To quantify the extent of body image disturbance found in the present study, a two-sample t-test was conducted in the R statistics software to compare the mean and standard deviation of body image disturbance found in our study to that of the sample on which the scale was originally validated. The R statistics software was required for this analysis as SPSS does not have the functionality for t-test comparisons based on summary data (i.e., means and standard deviations in absence of the raw data). ANCOVAs were then conducted for each follow-up outcome by study condition, controlling for the relevant identified covariates and pre-writing measures of the outcome.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 301406 0
University
Name [1] 301406 0
Macquarie University
Address [1] 301406 0
Dept of Psychology, Balaclava Rd, Nth Ryde NSW 2109
Country [1] 301406 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Road, North Ryde NSW 2109
Country
Australia
Secondary sponsor category [1] 301084 0
None
Name [1] 301084 0
Address [1] 301084 0
Country [1] 301084 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302142 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 302142 0
Balaclava Road, North Ryde NSW 2109
Ethics committee country [1] 302142 0
Australia
Date submitted for ethics approval [1] 302142 0
02/03/2016
Approval date [1] 302142 0
31/03/2016
Ethics approval number [1] 302142 0
5201600318

Summary
Brief summary
Participants accessed the website from a link provided in the SONA PArticipants pool for 1st year Psychology students at Macquarie University; OR accessed the link from a skin condition related FaceBook site: OR from a paper-based invitation on view at a Sydney-base dermatology clinic. Once accessing the study website interested participants provided informed consent (online) and were then taken directly to complete the online pre-survey. Immediately after completion of the survey, participants were randomly assigned to either the online self-compassion writing condition or the online control expressive writing condition. Each writing activity took 30mins maximum. Immediately following completion of the assigned writing condition, participants then completed the online post-survey.
Trial website
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 89262 0
Prof Kerry Sherman
Address 89262 0
Centre for Emotional Health, Department of Psychology,
Balaclava Rd, Nth Ryde, Macquarie University NSW 2109
Country 89262 0
Australia
Phone 89262 0
+61298506874
Fax 89262 0
+61298508062
Email 89262 0
kerry.sherman@mq.edu.au
Contact person for public queries
Name 89263 0
Prof Kerry Sherman
Address 89263 0
Centre for Emotional Health, Department of Psychology,
Balaclava Rd, Nth Ryde, Macquarie University NSW 2109
Country 89263 0
Australia
Phone 89263 0
+61298506874
Fax 89263 0
+61298508062
Email 89263 0
kerry.sherman@mq.edu.au
Contact person for scientific queries
Name 89264 0
Prof Kerry Sherman
Address 89264 0
Centre for Emotional Health, Department of Psychology,
Balaclava Rd, Nth Ryde, Macquarie University NSW 2109
Country 89264 0
Australia
Phone 89264 0
+61298506874
Fax 89264 0
+61298508062
Email 89264 0
kerry.sherman@mq.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
We do not have ethics approval to share these data.
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 814 0
Study protocol
Citation [1] 814 0
Link [1] 814 0
Email [1] 814 0
Other [1] 814 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
We found a significant increase in self-compassion in the My Changed Body writing group pre-post assessment, compared with the controls whose scores on self-compassion did not change. Similarly, the My Changed Body writing participants also reported a significant decrease in negative affect from pre-post assessment, compared with controls. There were no group differences in positive affect.