Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000496718
Ethics application status
Approved
Date submitted
25/02/2022
Date registered
29/03/2022
Date last updated
29/03/2022
Date data sharing statement initially provided
29/03/2022
Date results provided
29/03/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessing how practical a self-compassion-based body image intervention is for people with endometriosis
Scientific title
"My Changed Body" Body Image Intervention for People with Endometriosis: A Randomised Feasibility Study
Secondary ID [1] 306533 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis 325418 0
Body image 325419 0
Condition category
Condition code
Reproductive Health and Childbirth 322808 322808 0 0
Other reproductive health and childbirth disorders
Mental Health 322809 322809 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is called My Changed Body and is designed to increase participant levels of self-compassion towards themselves and their body by participants completing a series of self-compassionate writing tasks online, via a Qualtrics survey.

The experimental arm involves participants being provided with an overview of what self-compassion means in the form of a written paragraph in the online survey (approximately less than a minute's reading time), before responding to 6 self-compassionate writing prompts about their body. For example, "Keeping in mind how your body has changed as a result of having endometriosis, please write a paragraph showing understanding, kindness, and concern for yourself in a way you would help a friend who had undergone the experience."

The intervention is self-guided and conducted wholly online, on an individual basis. The intervention is delivered at baseline, a 1-week follow-up, a 1-month follow-up, and a 3-month follow-up. The baseline involves demographic items, baseline measures of psychological constructs (body image, self-compassion, depression and anxiety), and the initial 6 writing tasks, which are to be completed in the one sitting immediately after responding to the demographic items. The amount of writing given in response to each writing task is at the discretion of the participant for two of the writing tasks (though the writing prompts suggest providing a detailed response), whilst three of the writing tasks ask participants to write a paragraph, and one writing task asks participants to write a letter (of unspecified length). The written responses were not assessed. The baseline is estimated to take approximately 25 minutes all up. Each of the follow-ups involve the same measures of psychological constructs and a "top-up" of one of the self-compassionate writing prompts, i.e., participants were asked to respond to the last writing prompt from the baseline again ("Write a self-compassionate letter to yourself, perhaps extending this to a letter to all people with endometriosis. Having endometriosis, what are some of the things you've needed to hear about your body? What are you needing to say to yourself? What would you say to your friends and family, or more broadly, all people, struggling with these issues?"). Each follow-up is estimated to take 10 minutes.
Intervention code [1] 322961 0
Treatment: Other
Comparator / control treatment
The control arm is an active control and had participants complete 6 writing activities about a neutral subject, i.e., how they spent their time. For example, "Think about how you will spend tomorrow. Consider the main thing you will be doing. Describe in a factual way how your day would change if you did not do this thing. How would this affect the rest of your day?"

The control arm was self-guided and conducted wholly online, on an individual basis. The control arm was delivered at baseline, a 1-week follow-up, a 1-month follow-up, and a 3-month follow-up. The baseline involves demographic items, baseline measures of psychological constructs (body image, self-compassion, depression and anxiety), and the initial 6 writing tasks. This is estimated to take approximately 25 minutes all up. Each of the follow-ups involve the same measures of psychological constructs and a "top-up" of one of the neutral writing prompts. Each follow-up is estimated to take 10 minutes.
Control group
Active

Outcomes
Primary outcome [1] 330589 0
Recruitment rate, which was defined by recruiting 60 eligible participants; the median sample size for feasibility studies (Billingham et al., 2013). The parameter of recruiting this sample within 7 days was based on the authors’ previous experience in recruiting endometriosis samples.
The survey data was downloaded from Qualtrics and cleaned, before the number of completed baseline data points were counted.
Timepoint [1] 330589 0
7 days after the study promotion began.
Primary outcome [2] 330597 0
Program demand, as assessed by baseline completion rate (i.e., how many participants completed all demographics, baseline measures, writing tasks, and post-measures) and dropout rate from baseline to 1-week follow-up.
Timepoint [2] 330597 0
Baseline completion rate assessed at conclusion of recruitment period and dropout rate assessed at last date of 1-week follow-up.
Primary outcome [3] 330598 0
Program satisfaction, measured using the Program Feedback Scale (PFS; Schleider et al., 2019). A higher total score indicates higher program satisfaction.
Timepoint [3] 330598 0
Assessed in immediate post-measures.
Secondary outcome [1] 406836 0
Change in self-compassion as measured by the State Self-Compassion Scale Long Form (SSCS-L; Neff et al., 2021). There are no official thresholds to determine low, medium, or high self-compassion.
Timepoint [1] 406836 0
Baseline, immediate post-intervention (primary timepoint), 1-week, 1-month, and 3-months post-intervention.

Eligibility
Key inclusion criteria
Participants were included if they met the following criteria: 1) aged 18 or above, 2) living in Australia, 3) having received the endometriosis diagnosis via laparoscopy, and 4) could recall a negative experience regarding their body image in relation to endometriosis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

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 was concealed as it was conducted by Qualtrics.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software, i.e., Qualtrics' in-built random allocation function.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
A sample of 60 individuals was the aim, as this is the median sample size for comparable feasibility studies (Billingham, Whitehead, & Julious, 2013).
Four feasibility domains will be assessed: 1) program implementation in terms of the participant recruitment rate; 2) program demand in terms of the study completion rate, i.e., completing all the test items, and the dropout rate; 3) program satisfaction from the participants’ perspective; and 4) limited-efficacy testing on an intermediate variable.

The first three domains were addressed via simple descriptives, whilst an ANOVA was used to address the fourth domain.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/06/2021
Date of last participant enrolment
Anticipated
Actual
24/08/2021
Date of last data collection
Anticipated
Actual
1/10/2021
Sample size
Target
60
Accrual to date
Final
82
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 310875 0
University
Name [1] 310875 0
Deakin University
Country [1] 310875 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway, Burwood, VIC, 3125
Country
Australia
Secondary sponsor category [1] 312146 0
University
Name [1] 312146 0
Macquarie University
Address [1] 312146 0
Balaclava Rd, Macquarie Park NSW 2109
Country [1] 312146 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310436 0
Deakin University Human Ethics Advisory Group
Ethics committee address [1] 310436 0
Ethics committee country [1] 310436 0
Australia
Date submitted for ethics approval [1] 310436 0
01/03/2021
Approval date [1] 310436 0
29/04/2021
Ethics approval number [1] 310436 0
HEAG-H 25_2021

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

Contacts
Principal investigator
Name 117662 0
Dr Jacqueline Mills
Address 117662 0
Deakin University
221 Burwood Highway,
Burwood, VIC, 3125
Country 117662 0
Australia
Phone 117662 0
+61 3 92446379
Fax 117662 0
Email 117662 0
[email protected]
Contact person for public queries
Name 117663 0
Jacqueline Mills
Address 117663 0
Deakin University
221 Burwood Highway,
Burwood, VIC, 3125
Country 117663 0
Australia
Phone 117663 0
+61 3 92446379
Fax 117663 0
Email 117663 0
[email protected]
Contact person for scientific queries
Name 117664 0
Jacqueline Mills
Address 117664 0
Deakin University
221 Burwood Highway,
Burwood, VIC, 3125
Country 117664 0
Australia
Phone 117664 0
+61 3 92446379
Fax 117664 0
Email 117664 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
Ethics approval was not granted for IPD availability.


What supporting documents are/will be available?




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.