Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000158561p
Ethics application status
Submitted, not yet approved
Date submitted
23/01/2024
Date registered
20/02/2024
Date last updated
20/02/2024
Date data sharing statement initially provided
20/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of the Resilience smartphone application for eating disorder symptoms.
Scientific title
Efficacy of a dialectical behavior therapy skills training smartphone application for adults with eating disorder symptoms.
Secondary ID [1] 311393 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eating disorders 332666 0
Condition category
Condition code
Mental Health 329371 329371 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Resilience Smartphone Application.
Resilience is based on the theory and principles of dialectical behavioral therapy skills training for eating disorders. Its focus is on teaching users adaptive coping strategies to deal with negative emotional experiences without resorting to destructive eating disorder behaviors. It does so by teaching mindfulness, emotion regulation, and distress tolerance skills.
Resilience is an app that has three broad sections.
1. Modules: There are 5 modules to Resilience that aim to provide psychoeducation, case studies, and detailed rationales for the skills to implement.
2. Skills: A variety of skills-based tasks are offered for users to practice or engage in-the-moment to prevent the onset or exacerbation of symptoms.
3. Reflection: Users are encouraged to log and track their emotions and thoughts over time to establish their connections with problem eating behaviors.

The contents of the 5 modules are as follows:
1. Preparing for change: psychoeducational chapter about the DBT model of eating disorders as well as brief exercises designed to enhance motivation and commitment to change.
2. Connecting the dots: introduction to two fundamental techniques of DBT designed to help users understand how and why emotions can impact their eating: the diary card and chain analysis.
3. Mindfulness: teaches users about the concept of mindful awareness and theory, as well as why this state of mind is needed to address eating disorder symptoms.
4. Emotion regulation: teaches users about healthy vs. unhealthy ways of regulating emotions, and encourages systematic problem solving and daily pleasantries.
5. Distress tolerance: teaches users about the concept of distress tolerance and offers tips for helping users deal with a crisis.

Resilience is designed to be completed at a self-suited pace. Users are expected to go through the modules sequentially and to engage in skills they find most effective in a given circumstance. Users are encouraged to go through one module per week, as well as encouraged to engage in skills on a daily basis. Back-end data are captured, including number of logins, number of diary entries completed, time spent on the app, screens accessed and used. Content is presented in multimedia formats, including written text, info-graphics, video tutorials, and audio recordings.
Intervention code [1] 327831 0
Behaviour
Comparator / control treatment
Participants allocated to the control group will be sent a link to a website that offers basic information about disordered eating and will notified that they will have access to the smartphone app in 6 weeks.
As the website is open access, there will be no method to monitor adherence to this website. No instructions will be provided to participants about accessing the website, other than that it may contain useful information for better understanding the nature and function of eating disorder symptoms.
Control group
Active

Outcomes
Primary outcome [1] 337191 0
Eating disorder psychopathology
Timepoint [1] 337191 0
6 week follow-up
Primary outcome [2] 337192 0
Objective binge eating
Timepoint [2] 337192 0
6 week follow-up
Secondary outcome [1] 431003 0
Weight concerns
Timepoint [1] 431003 0
6 week follow-up
Secondary outcome [2] 431004 0
Shape concerns
Timepoint [2] 431004 0
6 week follow-up
Secondary outcome [3] 431005 0
Eating concerns
Timepoint [3] 431005 0
6 week follow-up
Secondary outcome [4] 431006 0
Subjective binge eating frequency
Timepoint [4] 431006 0
6 week follow-up
Secondary outcome [5] 431007 0
Compensatory behavior frequency
Timepoint [5] 431007 0
6 week follow-up
Secondary outcome [6] 431008 0
Psychological distress
Timepoint [6] 431008 0
6 weeks follow-up
Secondary outcome [7] 431009 0
Mindfulness
Timepoint [7] 431009 0
6 week follow-up
Secondary outcome [8] 431010 0
Emotion Regulation
Timepoint [8] 431010 0
6 week follow-up
Secondary outcome [9] 431011 0
Distress tolerance
Timepoint [9] 431011 0
6 week follow-up

Eligibility
Key inclusion criteria
Inclusion criteria will be (1) aged 18 years or over; (2) access to a smartphone, and (3) self-reported the presence of recurrent binge eating (loss of control overeating), defined as one episode per every two weeks, on average, over the past three months.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
There are no other exclusion criteria.

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)
Randomization will be performed via the Qualtrics platform. As this is a fully automated platform, the researchers have no way of knowing upcoming group assignments.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be performed via the Qualtrics platform.
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2024
Actual
Date of last participant enrolment
Anticipated
31/10/2024
Actual
Date of last data collection
Anticipated
18/12/2024
Actual
Sample size
Target
126
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 315652 0
Government body
Name [1] 315652 0
National Health and Medical Research Councol (APP1196948)
Country [1] 315652 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
1 Gheringhap St, Geelong VIC 3220
Country
Australia
Secondary sponsor category [1] 317756 0
None
Name [1] 317756 0
Address [1] 317756 0
Country [1] 317756 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314536 0
The Deakin University Human Research Ethics Committee
Ethics committee address [1] 314536 0
Ethics committee country [1] 314536 0
Australia
Date submitted for ethics approval [1] 314536 0
08/12/2023
Approval date [1] 314536 0
Ethics approval number [1] 314536 0

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

Contacts
Principal investigator
Name 131930 0
Dr Jake Linardon
Address 131930 0
Deakin University, 1 Gheringhap St, Geelong VIC 3220
Country 131930 0
Australia
Phone 131930 0
+61 3 924 46308
Fax 131930 0
Email 131930 0
[email protected]
Contact person for public queries
Name 131931 0
Jake Linardon
Address 131931 0
Deakin University, 1 Gheringhap St, Geelong VIC 3220
Country 131931 0
Australia
Phone 131931 0
+61 3 924 46308
Fax 131931 0
Email 131931 0
[email protected]
Contact person for scientific queries
Name 131932 0
Jake Linardon
Address 131932 0
Deakin University, 1 Gheringhap St, Geelong VIC 3220
Country 131932 0
Australia
Phone 131932 0
+61 3 924 46308
Fax 131932 0
Email 131932 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified anonymized raw data
When will data be available (start and end dates)?
After the publication of findings: expected May 2025. There will be no end date to data availability.
Available to whom?
Any researcher wishing to conduct re-analysis
Available for what types of analyses?
Any re-analysis or secondary analysis asking different questions
How or where can data be obtained?
[email protected]


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.