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Trial registered on ANZCTR


Registration number
ACTRN12619000485134p
Ethics application status
Submitted, not yet approved
Date submitted
12/03/2019
Date registered
25/03/2019
Date last updated
25/03/2019
Date data sharing statement initially provided
25/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Would you say that to a friend? - A study of feelings towards your body when experiencing symptoms of a visible skin condition. 

Scientific title
A Randomised Pilot of a Self-Compassionate Writing Intervention in Reducing Body Image Distress in Individuals with a Visible Skin Condition
Secondary ID [1] 297539 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Visible skin condition 311750 0
Condition category
Condition code
Skin 310376 310376 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The My Changed Body intervention will be accessed by participants in two sessions: (1) the complete My Changed Body writing exercise (2) a brief version of the MyCB writing exercise.

The complete My Changed Body writing exercise is designed to enhance self-compassion through a series of 6 guided self-compassion writing prompts. It has been developed for use in the breast cancer context and successfully trialed and published. A pilot study also supports that My Changed Body immediately increased self-compassion in individuals with visible skin conditions. The writers begin the writing exercise with a general description of a negative event related to changes in their body. This is proceeded by a sequence of 5 brief writing prompts which aims to assist participants to view their skin condition negative body-related experience in a more self-compassionate light. The exercise entails approximately 20 minutes 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 will need to progress through the writing task. Any participants not choosing to complete the writing will be able to withdraw from the study through their non-completion and by closing the browser.

An example of the writing prompts is:
Kind advice: 
Keeping in mind how your body has changed as a result of having a skin condition, please write a paragraph showing understanding, kindness, and concern for yourself in a way you would help a friend who had undergone the experience.

Secondly, participants will access the brief version the My Changed Body intervention. The brief My Changed Body intervention is an extension of the complete MyCB writing task and with 1 prompt to write self-compassionately (i.e. with kindness) about their personal situation. This will be administered 1 week following the initial intervention. The researchers will email participants with a link to a brief version of the intervention. With additional reminder emails at 24 and 36 hours after the link has been sent. The brief version of the intervention is expected to take 10 minutes to complete. This session begins by reminding participants about their previous self-compassionate writing session.

This is followed by the prompt example below:

This session you will write a second self-compassionate letter to yourself. Try to write in a way that expresses kindness and understanding in relation to your skin condition. What are you needing to say to yourself? What would you say to all people who are struggling with these issues?
Intervention code [1] 313793 0
Treatment: Other
Comparator / control treatment
The control group will also access the writing intervention in two parts: (1) Complete writing activity (2) Brief version of the writing activity.

The control group will also undertake a 20-minute writing exercise. In this case, objective writing discussing a familiar room in a factual and detail-orientated way. This control condition mirrors the intervention condition in the format of the writing exercise, prompting them to write about different aspects of the room through 6 guided writing prompts.

See the example below:
Please write a paragraph in as much as possible detail describing the small objects in the room.

Similarly, to the experimental condition, participants in the control condition will complete a brief writing intervention 1 week following the first writing activity. This writing intervention is an extension of the previous writing session and is expected to take 10 minutes to complete. The writing activity begins by reminding participants of their previous session which was conducted in a factual and detail orientated way. This is followed by a single writing prompt, see the exampled below:

For this writing session think about different, yet familiar, room an objective and factual way. Your descriptions should be information only and not include comments regarding your thoughts or feelings about this room. For this writing task please write a factual and detail orientated paragraph describing the “different” room. This should include all the items in the room, and how they fit together to serve a purpose in the room.
Control group
Active

Outcomes
Primary outcome [1] 319279 0
Body Image Distress - Negative aspects of body image were measured with the 7-item Body Image Disturbance Questionnaire (Cash, Phillips, Santos, & Hrabosky, 2004). This scale was chosen as it assesses body-image specific distress rather than general psychological distress.
Timepoint [1] 319279 0
1-month post-enrolment
Secondary outcome [1] 367543 0
Negative Affect – Measured with the 20-item Positive and Negative Affect Schedule (Watson, Clark & Tellegen, 1988) consisting of a 10-item momentary positive affect subscale and a 10-item momentary negative affect subscale.
Timepoint [1] 367543 0
Post-treatment, 1 week and 1-month post-enrolment
Secondary outcome [2] 367545 0
Self-compassion – Measured with the 12-item Self-compassion Scale-Short Form (Raes, Pommier, Neff, & Van Gucht, 2011).
Timepoint [2] 367545 0
1 week and 1 month post enrolment
Secondary outcome [3] 367547 0
Self-perception of the effect of the intervention – measures with five questions adapted from past expressive and self-compassionate writing literature (Ziemer et al., 2019) (a) How personal were your essays? (b) To what degree did you reveal your emotions in your essays? (c) Do you believe that writing about this topic has affected how you think about this topic? (d) Do you believe facing this topic in your writing has improved the way you feel about it? and (e) To what degree did writing about this topic make you feel understood and more accepting of your body?
Timepoint [3] 367547 0
Immediately after each administration of the intervention (that is, immediate and 1 week).
Secondary outcome [4] 368123 0
Body Image Distress - Negative aspects of body image were measured with the 7-item Body Image Disturbance Questionnaire (Cash, Phillips, Santos, & Hrabosky, 2004). This scale was chosen as it assesses body-image specific distress rather than general psychological distress.
Timepoint [4] 368123 0
1-week post-enrolment

Eligibility
Key inclusion criteria
Participants are eligible to participate if they self-identify as the following: a) over 18 years of age, b) currently experiencing symptoms of a visible skin condition (e.g. acne, eczema, dermatitis, psoriasis, etc.) c) had experienced at least one negative event related to their skin condition. All participants will 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
Not applicable

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 will be administered entirely online so randomisation will occur online. Participants were informed that they would take part in a writing exercise. Concealment will be 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Active control group using an objective writing task, so that time and the effect of writing can be accounted for.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
All analyses will be performed in SPSS version 25.0 (IBM Corp., 2017) unless otherwise specified. Significance will be set at 0.05 for all tests. Descriptive analyses will outline sample characteristics. Chi-square and t-test analyses will be used to compare baseline demographics, medical history and previous experience with therapeutic writing task across conditions, and identify covariates for inclusion in subsequent mixed-model analyses. Main analyses will be based on a group (two conditions) by time (three assessments: baseline, 1 week and 1 month) randomised design within an intent-to-treat framework. Linear mixed models analyses will be used to assess effects of the intervention (condition) over time, controlling for baseline outcome levels and identified confounding variables. Fixed effects will include Time, Condition and the interaction of Time*Condition, baseline outcome levels and identified confounding variables. Random effects for a participant-specific random intercept will account for within-participant correlation. We will use a two-sided significance level of a=.05 for all analyses.

Recruitment
Recruitment status
Not yet recruiting
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] 302096 0
University
Name [1] 302096 0
Macquarie University
Address [1] 302096 0
Dept of Psychology, Balaclava Rd, Nth Ryde NSW 2109
Country [1] 302096 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Road, North Ryde NSW 2109
Country
Australia
Secondary sponsor category [1] 301923 0
None
Name [1] 301923 0
Address [1] 301923 0
Country [1] 301923 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 302775 0
Macquarie University Human Research Ethics Comittee
Ethics committee address [1] 302775 0
Balaclava Road, North Ryde NSW 2109
Ethics committee country [1] 302775 0
Australia
Date submitted for ethics approval [1] 302775 0
25/02/2019
Approval date [1] 302775 0
Ethics approval number [1] 302775 0

Summary
Brief summary
Participants will access the website from a link provided in the SONA Participants pool for 1st year Psychology students at Macquarie University. Once accessing the study website interested participants provided informed consent (online) and will be taken directly to complete the online pre-survey. Immediately after completion of the survey, participants will be randomly assigned to either the online self-compassion writing condition or the online control objective writing condition. Each writing activity will take 25mins maximum. One week following the baseline questionnaire completion, researchers will email participants a follow-up questionnaire. After completing the follow-up questionnaire, participants will engage in a brief version of the previous writing exercise as per allocated condition. Approximately one-month post baseline assessment participants will be emailed a link to the final questionnaire to complete.
Trial website
N/A
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91358 0
Prof Kerry Sherman
Address 91358 0
Centre for Emotional Health, Department of Psychology, Balaclava Rd, Nth Ryde, Macquarie University NSW 2109
Country 91358 0
Australia
Phone 91358 0
+61 298506874
Fax 91358 0
+61 298508062
Email 91358 0
kerry.sherman@mq.edu.au
Contact person for public queries
Name 91359 0
Prof Kerry Sherman
Address 91359 0
Centre for Emotional Health, Department of Psychology, Balaclava Rd, Nth Ryde, Macquarie University NSW 2109
Country 91359 0
Australia
Phone 91359 0
+61 298506874
Fax 91359 0
+61 298508062
Email 91359 0
kerry.sherman@mq.edu.au
Contact person for scientific queries
Name 91360 0
Prof Kerry Sherman
Address 91360 0
Centre for Emotional Health, Department of Psychology, Balaclava Rd, Nth Ryde, Macquarie University NSW 2109
Country 91360 0
Australia
Phone 91360 0
+61 298508062
Fax 91360 0
+61 298508062
Email 91360 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 have not requested ethics approval to share these data.
What supporting documents are/will be available?
Study protocol
Other
'Other' documents specified
Study questionnaire (Master with all surveys included)
How or where can supporting documents be obtained?
Type [1] 1469 0
Study protocol
Citation [1] 1469 0
Link [1] 1469 0
Email [1] 1469 0
Other [1] 1469 0
Type [2] 1605 0
Other
Citation [2] 1605 0
Link [2] 1605 0
Email [2] 1605 0
Other [2] 1605 0
Study questionnaire (Master with all surveys included)
Summary results
No Results