Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001218381
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
16/09/2026
Date registered
Help: Date registered
1/10/2026
Date last updated
Help: Date last updated
1/10/2026
Date data sharing statement initially provided
Help: Data sharing statement date
1/10/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of a consumer co-designed psychological Intervention for body image dissatisfaction for individuals living with inflammatory bowel disease
Scientific title
A randomised controlled trial evaluating the effectiveness of a consumer co-designed online-based psychological intervention, with or without peer support, on body image dissatisfaction in adults living with inflammatory bowel disease
Additional trial identifiers [1] 318457 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Body image dissatisfaction 343631 0
Inflammatory bowel disease 343720 0
Condition category
Condition code
Oral and Gastrointestinal 339744 339744 0 0
Inflammatory bowel disease
Mental Health 339832 339832 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Arm 1 – Online body image and wellbeing intervention
Participants will complete a consumer co-designed digital body image and wellbeing intervention developed specifically for adults living with inflammatory bowel disease (IBD). The intervention consists of 10 self-guided modules delivered online via Qualtrics over approximately 3 weeks. Modules will be released every few days and each will take approximately 5–20 minutes to complete. Content is primarily text-based and includes brief psychoeducation, guided reflection, and interactive skills-based activities and exercises. Strategies include goal setting, cognitive restructuring and thought diaries, reducing body checking and avoidance, body functionality activities, self-worth reflection, strategies relating to social media use, mindfulness, and self-compassion. Participants will complete the intervention remotely using their own internet-enabled device. Adherence to the intervention will be monitored using Qualtrics completion data to determine whether participants complete each of the intervention modules.

Arm 2 – Online body image and wellbeing intervention plus peer support
Participants will complete the same 10-module digital intervention described in Arm 1. In addition, participants will be invited to join an invite-only private Facebook peer support group for people living with IBD. The Facebook group will be available throughout the approximately 3-week intervention period. Participation in the group will be at the participant’s discretion, with no scheduled individual or group support sessions or minimum level of participation required. Participants will be able to read and respond to discussion prompts, share experiences, post comments, and interact with other group members. Regular discussion prompts will also be posted to encourage conversation and peer support. The group will be moderated by a provisional psychologist under the supervision of a registered clinical psychologist. No minimum level of engagement with the peer support group will be required, and adherence to this component will not be formally assessed.

Arm 3 – Waitlist control
Participants allocated to the waitlist control condition will not receive the intervention during the initial study period but will complete the same assessment schedule as the intervention groups. Following completion of the follow-up assessment, participants will be offered access to the online intervention.
Intervention code [1] 335368 0
Behaviour
Description of the comparator or control
Arm 3 – Waitlist control: Participants allocated to the waitlist control condition did not receive the intervention during the initial study period. They completed the same outcome assessments as the intervention group at baseline, after approximately three weeks, and at one-month follow-up. After completing their final questionnaire, participants in the waitlist control group were offered access to the intervention.
Control group
Active

Outcomes
Primary outcome [1] 346914 0
Body Dissatisfaction
Timepoint [1] 346914 0
Baseline, immediately following completion of the 3-week intervention (approximately 3 weeks after baseline; primary timepoint), and 1-month post-intervention completion follow-up (approximately 7 weeks after baseline).
Secondary outcome [1] 468122 0
Body appreciation
Timepoint [1] 468122 0
Baseline, post-intervention (approximately 3 weeks after baseline), and 1-month post-intervention completion follow-up (approximately 7 weeks after baseline).
Secondary outcome [2] 468123 0
Eating disorder psychopathology
Timepoint [2] 468123 0
Baseline, post-intervention (approximately 3 weeks after baseline), and 1-month post-intervention completion follow-up (approximately 7 weeks after baseline).
Secondary outcome [3] 468124 0
Depressive symptoms
Timepoint [3] 468124 0
Baseline, post-intervention (approximately 3 weeks after baseline), and 1-month post-intervention completion follow-up (approximately 7 weeks after baseline).
Secondary outcome [4] 468127 0
Anxiety symptoms
Timepoint [4] 468127 0
Baseline, post-intervention (approximately 3 weeks after baseline), and 1-month post-intervention completion follow-up (approximately 7 weeks after baseline).
Secondary outcome [5] 468128 0
Health-related quality of life / health status
Timepoint [5] 468128 0
Baseline, post-intervention (approximately 3 weeks after baseline), and 1-month post-intervention completion follow-up (approximately 7 weeks after baseline).

Eligibility
Key inclusion criteria
Diagnosis of inflammatory bowel disease (IBD), including Crohn’s disease or ulcerative colitis.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Participants were excluded if they were under 18 years of age or did not have a diagnosis of inflammatory bowel disease. No other specific exclusion criteria were applied.

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 through automated randomisation within Qualtrics. Group assignment was generated only after enrolment, and the allocation could not be predicted in advance.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random allocation using the Qualtrics randomiser, with participants randomly assigned to either the intervention, intervention and per support group or waitlist control group.
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
Recruiting
Date of first participant enrolment
Anticipated
Actual
13/07/2026
Date of last participant enrolment
Anticipated
27/11/2026
Actual
Date of last data collection
Anticipated
21/01/2027
Actual
Sample size
Target
420
Accrual to date
39
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 323039 0
University
Name [1] 323039 0
Flinders Foundation Health Seed Grant
Country [1] 323039 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Country
Australia
Secondary sponsor category [1] 325985 0
None
Name [1] 325985 0
Address [1] 325985 0
Country [1] 325985 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321444 0
Flinders University Human Research Ethics Committee
Ethics committee address [1] 321444 0
Ethics committee country [1] 321444 0
Australia
Date submitted for ethics approval [1] 321444 0
10/04/2026
Approval date [1] 321444 0
05/06/2026
Ethics approval number [1] 321444 0

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

Contacts
Principal investigator
Name 153746 0
Dr Mia Pellizzer
Address 153746 0
Flinders University, Sturt Road, Bedford Park, SA 5042
Country 153746 0
Australia
Phone 153746 0
+610882013664
Fax 153746 0
Email 153746 0
[email protected]
Contact person for public queries
Name 153747 0
Mia Pellizzer
Address 153747 0
Flinders University, Sturt Road, Bedford Park, SA 5042
Country 153747 0
Australia
Phone 153747 0
+610882013664
Fax 153747 0
Email 153747 0
[email protected]
Contact person for scientific queries
Name 153748 0
Mia Pellizzer
Address 153748 0
Flinders University, Sturt Road, Bedford Park, SA 5042
Country 153748 0
Australia
Phone 153748 0
+610882013664
Fax 153748 0
Email 153748 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.