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Trial registered on ANZCTR


Registration number
ACTRN12621000353897
Ethics application status
Approved
Date submitted
2/02/2021
Date registered
29/03/2021
Date last updated
20/06/2022
Date data sharing statement initially provided
29/03/2021
Date results provided
20/06/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Piloting a Treatment to Address Social Media Use and Eating Disorder Risk in University Students
Scientific title
Piloting a Self-Criticism Intervention Addressing the Relationship Between Social Media Use and Eating Disorder Risk in University Students
Secondary ID [1] 303276 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eating disorders 320554 0
Self-criticism 320555 0
Body image dissatisfaction 320556 0
Condition category
Condition code
Mental Health 318411 318411 0 0
Eating disorders
Mental Health 318759 318759 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Primary intervention: self-criticism intervention.

Participants are emailed a set of intervention modules in fillable PDF format, which use CBT techniques to address self-criticism in the context of appearance and social media. These are self-guided interventions which can be completed either on the computer or printed to be completed in hard copy. The intervention comprises 4 modules, each of which takes approximately 15 minutes to complete, and which we will ask that they complete over one week. Because the intervention is delivered to participants digitally, it can be completed by participants in the location of their choosing. Participants will be asked to complete questionnaires of primary and secondary outcomes at baseline, post-treatment, and one-week follow-up (the latter of which is optional).

The intervention modules are not available from another source; this study is designed to test their feasibility and this is the first time they are being trialled. The first intervention module provides psychoeducation about self-criticism and self-compassion and the homework task asks participants to record 5 instances over a couple of days where they either self-criticise or use self-compassion. In the second module, the participant is asked to reflect on what they learned from the homework task, further psychoeducation about self-criticism and self-compassion is provided, and they complete a questionnaire about self-compassion to help them determine the things that get in the way of using self-compassion. The homework task for the second module is to run a behaviour experiment over the next 2 days where they use self-criticism one day and self-compassion the next day and record the outcomes of each approach. The third module includes a homework review, guides the development of individualised self-compassionate messages, and runs through an imagery rescripting exercise about a recent instance of self-compassion. The module three homework is to review the rescripted memory the following day. The final module includes a homework review, a problem-solving exercise around how to make changes to the way one uses social media to make it less likely to cause self-criticism about one's body and appearance. The homework for this final module is to implement the plan made during the problem-solving exercise and evaluate whether it has been helpful. There is one homework task per module, so 4 tasks in total, and each is designed to take 5-10 minutes to complete. The modules ask that participants complete each homework task before starting the next module.

Intervention adherence will be assessed by questions in the post-treatment questionnaires asking for estimates of how much of the modules and the homework they completed.

_______________________________________________________________________

Active control: social media curation intervention.

Participants are emailed a set of intervention modules in fillable PDF format, which use CBT techniques to encourage participants to problem-solve their social media use and its impact on how they feel about their appearance. These are self-guided interventions which can be completed either on the computer or printed to be completed in hard copy. The intervention comprises 4 modules, each of which takes approximately 15 minutes to complete, and which we will ask that they complete over one week. Because the intervention is delivered to participants digitally, it can be completed by participants in the location of their choosing. Participants will be asked to complete questionnaires of primary and secondary outcomes at baseline, post-treatment, and one-week follow-up (the latter of which is optional).

The intervention modules are not available from another source; this study is designed to test their feasibility and this is the first time they are being trialled. The first intervention module provides psychoeducation about social media and its relationship to eating disorder risk, and the homework task asks participants to record for 2 days when and why they use social media, and how it makes them feel. In the second module, the participant is asked to reflect on what they learned from the homework task and psychoeducation about social media literacy is provided. The homework task for the second module is to record examples of inauthentic/unrealistic things they see on social media. The third module includes a homework review and then asks participants to start considering the positives and negatives about their social media use and how they might be able to change it to make it more positive. The module three homework is to record over 2 days the types of content they see on social media and whether seeing that impacts them positively or negatively. The final module includes a homework review and then guides participants through the process of "curating their feed" - making changes to their social media use so that it may impact more positively on their wellbeing. The homework for this final module is to implement the plan for curating their feed and evaluate how social media impacts on their feelings now. There is one homework task per module, so 4 tasks in total, and each is designed to take 5-10 minutes to complete. The modules ask that participants complete each homework task before starting the next module.

Intervention adherence will be assessed by questions in the post-treatment questionnaires asking for estimates of how much of the modules and the homework they completed.
Intervention code [1] 319629 0
Behaviour
Intervention code [2] 319870 0
Treatment: Other
Comparator / control treatment
Control: waitlist.

Participants assigned to this condition will complete baseline questionnaires, then post-treatment questionnaires of secondary outcome measures a week later, and then an optional one-week follow-up questionnaire following that. Following this, they will be provided the self-criticism intervention modules via email. The modules will be sent after the primary researcher confirms that they have completed the post-treatment questionnaires if they do not consent to be contacted for follow-up. If they do consent to be contacted for the follow-up questionnaires, the modules will be sent after the primary researcher confirms that they have completed the follow-up questionnaires or 2 weeks after first being sent the link to the follow-up questionnaires (whichever occurs first).
Control group
Active

Outcomes
Primary outcome [1] 326391 0
Feasibility, assessed by % of module completion (self-reported using study-specific item: "Can you please enter an estimate of how much (as a percentage) of the intervention modules you completed (i.e., how much you read and how many questions you answered in the PDFs)?")
Timepoint [1] 326391 0
Post-treatment (1 week post-randomisation)
Primary outcome [2] 326392 0
Feasibility, assessed by % of homework completion (self-reported using study-specific item: "Can you please enter an estimate of how much (as a percentage) of the homework tasks you completed?")
Timepoint [2] 326392 0
Post-treatment (1 week post-randomisation)
Primary outcome [3] 326393 0
Acceptability of the intervention (qualitative feedback provided via online post-treatment questionnaires using study-specific items: "What did you like about the intervention?", "What did you dislike about the intervention?", and "Do you have any other feedback for us?")
Timepoint [3] 326393 0
Post-treatment (1 week post-randomisation)
Secondary outcome [1] 391289 0
Cohen's d effect size change in using social media for appearance-related reasons, measured using the appearance motivations subscale of the Motivations for Social Media Use Scale (MSMU; Rodgers et al., 2020)
Timepoint [1] 391289 0
Post-treatment (1 week post-randomisation) and 1-week follow-up (2 weeks post-randomisation)
Secondary outcome [2] 391290 0
Cohen's d effect size change in appearance comparison, measured using the Physical Appearance Comparison Scale - Revised (PACS-R; Schaefer & Thompson, 2014)
Timepoint [2] 391290 0
Post-treatment (1 week post-randomisation) and 1-week follow-up (2 weeks post-randomisation)
Secondary outcome [3] 391291 0
Cohen's d effect size change in self-criticism, measured with the self-criticism subscale of the Reconstructed Depressive Experiences Questionnaire (RecDEQ; Bagby et al., 1994)
Timepoint [3] 391291 0
Post-treatment (1 week post-randomisation) and 1-week follow-up (2 weeks post-randomisation)
Secondary outcome [4] 391292 0
Cohen's d effect size change in body image flexibility, measured using the Body Image Acceptance and Action Questionnaire (BIAAQ; Ferreira, Pinto-Gouveia, & Duarte, 2011)
Timepoint [4] 391292 0
Post-treatment (1 week post-randomisation) and 1-week follow-up (2 weeks post-randomisation)
Secondary outcome [5] 391293 0
Cohen's d effect size change in disordered eating, measured using the Short Form of the Eating Disorder Examination Questionnaire (EDE-QS; Gideon et al., 2016)
Timepoint [5] 391293 0
Post-treatment (1 week post-randomisation) and 1-week follow-up (2 weeks post-randomisation)

Eligibility
Key inclusion criteria
Participants must be university students aged 17 to 25 who are fluent in English and feel that they use social media for appearance-related reasons.
Minimum age
17 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People who are currently undergoing treatment for self-criticism, body image concerns, or disordered eating.

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 to conditions will be carried out automatically by a function embedded in the online baseline questionnaires, so with no involvement by the researchers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomise function provided by Qualtrics (i.e., computer software).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/03/2021
Date of last participant enrolment
Anticipated
Actual
14/10/2021
Date of last data collection
Anticipated
Actual
26/10/2021
Sample size
Target
80
Accrual to date
Final
202
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 307686 0
University
Name [1] 307686 0
Flinders University
Country [1] 307686 0
Australia
Funding source category [2] 308004 0
Government body
Name [2] 308004 0
Australian Government Department of Education, Skills and Employment
Country [2] 308004 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Sturt Rd, Bedford Park, South Australia 5042
Country
Australia
Secondary sponsor category [1] 308441 0
None
Name [1] 308441 0
Address [1] 308441 0
Country [1] 308441 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307722 0
Flinders University Human Research Ethics Committee
Ethics committee address [1] 307722 0
Ethics committee country [1] 307722 0
Australia
Date submitted for ethics approval [1] 307722 0
Approval date [1] 307722 0
30/09/2020
Ethics approval number [1] 307722 0

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

Contacts
Principal investigator
Name 108274 0
Ms Madelaine de Valle
Address 108274 0
Flinders University, Sturt Rd, Bedford Park South Australia 5042
Country 108274 0
Australia
Phone 108274 0
+61 8 8201 7821
Fax 108274 0
Email 108274 0
madelaine.devalle@flinders.edu.au
Contact person for public queries
Name 108275 0
Madelaine de Valle
Address 108275 0
Flinders University, Sturt Rd, Bedford Park South Australia 5042
Country 108275 0
Australia
Phone 108275 0
+61 8 8201 7821
Fax 108275 0
Email 108275 0
madelaine.devalle@flinders.edu.au
Contact person for scientific queries
Name 108276 0
Madelaine de Valle
Address 108276 0
Flinders University, Sturt Rd, Bedford Park South Australia 5042
Country 108276 0
Australia
Phone 108276 0
+61 8 8201 7821
Fax 108276 0
Email 108276 0
madelaine.devalle@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All deidentified IPD.
When will data be available (start and end dates)?
Data will be available one year following publication, with no end date determined at this time.
Available to whom?
Case-by-case basis at the discretion of the researchers.
Available for what types of analyses?
At this time, we plan to make data available for any purpose, but will review on a case-by-case basis.
How or where can data be obtained?
Access subject to approval by primary researcher: madelaine.devalle@flinders.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10417Ethical approval  madelaine.devalle@flinders.edu.au
10418Informed consent form  madelaine.devalle@flinders.edu.au



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseTargeting the link between social media and eating disorder risk: A randomized controlled pilot study.2022https://dx.doi.org/10.1002/eat.23756
N.B. These documents automatically identified may not have been verified by the study sponsor.