Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000267651
Ethics application status
Approved
Date submitted
27/02/2023
Date registered
13/03/2023
Date last updated
13/03/2023
Date data sharing statement initially provided
13/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
An online skills-based educational tool for eating disorders: SkillED Program Evaluation
Scientific title
Evaluating the efficacy of an online skills-based educational tool on eating disorder symptoms: SkillED Program Evaluation
Secondary ID [1] 308662 0
None
Universal Trial Number (UTN)
None
Trial acronym
SkillED
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Eating disorders 328660 0
Condition category
Condition code
Mental Health 325676 325676 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The SkillED Program is an online self-help education program. It is aimed for users 14 years+ who are experiencing subclinical or clinical symptoms of an eating disorder. The SkillED program draws upon the key principles of cognitive behaviour therapy and is therefore in accordance with the Royal Australian and New Zealand College of Psychiatrists clinical practice guidelines for the treatment of eating disorders (Hay et al., 2014).  It offers 11 modules including 5 core modules of evidence-based psychoeducation and skills, such as motivation, self-monitoring, disordered and regular eating, and 6 optional modules selected by participants including role of cognition, emotions, external triggers, dietary rules, body image and relapse prevention. Participants will be given one-week to complete each module. Participants will have access to the SkillED Program up for to 26 weeks from initial enrolment (depending on their selection of optional modules).

Users of SkillED will be required to complete 5 core modules before being able to access the optional 6 modules which they can self-select. The additional six modules are optional and can be repeated as often as desired within the access period. Each module is approximately 40-50 minutes long and include a series of short videos as well as interactive activities and quizzes. Participants will be asked to select which optional modules they would like to complete at the beginning of the program, and also to reconfirm their selection of optional modules after completing the core modules so that, if desired, they can adjust their choices to better suit to their learning needs. An adjunct digital self-monitoring tool is available as part of the SkillED program (i.e., treatment tools that will enable participants to self-monitor their activities during the program e.g., Food Monitoring, Behaviour Monitoring, Food Planner, Thought Challenge, and Exposure Tool).

To assess engagement with the SkillED program, we will collect usage data. When participants use the SkillED Program, the digital platform itself will automatically record usage patterns.
Intervention code [1] 325194 0
Treatment: Other
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333530 0
Eating symptomology of participants by the change on the global Eating Disorder Examination Questionnaire (EDE-Q)
Timepoint [1] 333530 0
Baseline (T1);
Post Core Module (T3): Post completion of the 5th core module (primary endpoint);
Post Optional Module (T5): Post completion of the self-selected optional module(s);
3-month follow-up (T6): 3-month after completion of the self-selected learning modules (with/without optional modules)
For participants who do not select the optional modules as part of their online learning program, they will not be assessed at T5, but the next measurement will be taken at T6.
Secondary outcome [1] 417435 0
Change on behavioural items of the EDE-Q
Timepoint [1] 417435 0
Baseline (T1);
Post Core Module (T3): Post completion of the 5th core module;
Post optional module (T5): Post completion of the self-selected optional module(s);
3-month follow-up (T6): 3-month after completion of the self-selected learning modules (with/without optional modules)
For participants who do not select the optional modules as part of their online learning program, they will not be assessed at T5, but the next measurement will be taken at T6.
Secondary outcome [2] 417436 0
General mental health and quality of life of participants by change on the Depression, Anxiety and Stress Scale-21 (DASS-21)
Timepoint [2] 417436 0
Baseline (T1);
Post Core Module (T3): Post completion of the 5th core module;
Post optional module (T5): Post completion of the self-selected optional module(s);
3-month follow-up (T6): 3-month after completion of the self-selected learning modules (with/without optional modules)
For participants who do not select the optional modules as part of their online learning program, they will not be assessed at T5, but the next measurement will be taken at T6.
Secondary outcome [3] 417439 0
Eating Disorder Stage of Change
Timepoint [3] 417439 0
Baseline (T1);
Post core module (T3): Post completion of the 5th core module;
Post optional module (T5): Post completion of the self-selected optional module(s);
3-month follow-up (T6): 3-month after completion of the self-selected learning modules (with/without optional modules)

For participants who do not select the optional modules as part of their online learning program, they will not be assessed at T5, but the next measurement will be taken at T6.
Secondary outcome [4] 417440 0
Participant usage of SkillED modules via software usage analytics


Timepoint [4] 417440 0
Post-core module (T3): Post completion of the 5th core module
Post-optional module (T5): Post completion of self-selected optional module(s)
3-month follow-up (T6): Post completion of selected learning module (with/without optional modules)
For participants who do not select the optional modules as part of their online learning program, they will not be assessed at T5, but the next measurement will be taken at T6.
Secondary outcome [5] 417441 0
Brief pre-post module acceptability and feasibility questions on a 5-point Likert scale


Timepoint [5] 417441 0
Post core module (T3): Post completion of the 5th core module
Post optional module (T5): Post completion of self-selected optional module(s)

For participants who do not select the optional modules as part of their online learning program, they will not be assessed at T5, but the next measurement will be taken at T6.
Secondary outcome [6] 419246 0
Knowledge, willingness, and confidence of participants to engage with treatment by brief pre-post module knowledge, willingness, and confidence questions on a 5-point Likert scale
Timepoint [6] 419246 0
Pre-core module (T2): Before completion of core module
Post core module (T3): Post completion of the 5th core module
Pre-optional module (T4): Before completion of self-selected optional module
Post optional module (T5): Post completion of self-selected optional module(s)
For participants who do not select the optional modules as part of their online learning program, they will not be assessed at T4 and T5.
Secondary outcome [7] 419251 0
Motivation to engage with treatment by Adapted General Help-Seeking Questionnaire
Timepoint [7] 419251 0
Baseline (T1);
Post-core module (T3): Post completion of the 5th core module
Post-optional module (T5): Post completion of self-selected optional module(s)
3-month follow-up (T6): Post completion of self-selected learning module (with/without optional modules)
For participants who do not select the optional modules as part of their online learning program, they will not be assessed at T5, but the next measurement will be taken at T6.
Secondary outcome [8] 419256 0
Dropout rates and reasons for dropout reported by participants
Timepoint [8] 419256 0
Post-core module (T3): Post completion of the 5th core module
Post-optional module (T5): Post completion of self-selected optional module(s)
3-month follow-up (T6): Post completion of self-selected learning module (with/without optional modules)
For participants who do not select the optional modules as part of their online learning program, they will not be assessed at T5, but the next measurement will be taken at T6.
Secondary outcome [9] 419257 0
USE (Usability, Satisfaction, and Ease of Use) questionnaire
Timepoint [9] 419257 0
Post-core module (T3): Post completion of the 5th core module
Post-optional module (T5): Post completion of self-selected optional module(s)
3-month follow-up (T6): Post completion of self-selected learning module (with/without optional modules)

For participants who do not select the optional modules as part of their online learning program, they will not be assessed at T5, but the next measurement will be taken at T6.
Secondary outcome [10] 419258 0
Qualitative feedback on the accessibility and feasibility of SkillED by open-ended evaluation feedback questions and qualitative interviews (to be conducted with a subset of participants) by a semi-structured interview with a member of the research team
Timepoint [10] 419258 0
Post-core module (T3): Post completion of the 5th core module
Post-optional module (T5): Post completion of self-selected optional module(s)

For participants who do not select the optional modules as part of their online learning program, they will not be assessed at T5, but the next measurement will be taken at T6.
Secondary outcome [11] 419259 0
To assess the safety of SkillED program by Self-harm assessment
Timepoint [11] 419259 0
Weekly monitoring from Baseline (T1) to either Post completion of the 5th core modules (T3) OR Post completion of the self-selected optional modules (T5)

For participants who do not select the optional modules as part of their online learning program, they will not be assessed at T5
Secondary outcome [12] 419260 0
To assess the safety of SkillED by monitoring self-reported weight of the participants
Timepoint [12] 419260 0
At Week 4 and If there is evidence of rapid weight loss (i.e., an average of greater than or equal to 1kg weight loss per week since baseline) OR if BMI < 16 (for ages 18+ years) OR if BMI is < 80% of median BMI (for ages 14 – 17 years), then self-reported weekly weight will be assessed for the duration of the trial.
Secondary outcome [13] 419436 0
To assess the safety of SkillED program by suicidal risk assessment
Timepoint [13] 419436 0
Weekly monitoring from Baseline (T1) to either Post completion of the 5th core modules (T3) OR Post completion of the self-selected optional modules (T5)

For participants who do not select the optional modules as part of their online learning program, they will not be assessed at T5

Eligibility
Key inclusion criteria
• Age 14 years and above
• Clinical and subclinical population: satisfies DSM-5 criteria for Anorexia Nervosa (AN), Bulimia Nervosa (BN), Binge Eating Disorder (BED), Other Specified Feeding and Eating Disorder (OSFED), Unspecified feeding or eating disorder (UFED) and/or experience ED symptomatology
• Access to a computer or device with internet connection
• % EBW greater than or equal 80% for individual 14 – 17 years or BMI>15 for individual aged > 18
• Living in Australia
Minimum age
14 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Non-proficient English speakers

- Active suicide attempt or planning of suicide in the past 28 days

- Pregnant

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive statistics will be conducted for sociodemographic and psychological characteristics, as well as usage analytics and feedback to evaluate program acceptability and feasibility. Characteristics of those who complete all core modules will be compared to with those who complete additional optional modules. Characteristics of completers and non-completers will also be compared using chi-square tests of independence (categorical variables) and independent samples t-tests (numeric variables).

Generalised linear mixed model (GLMM) will be used to determine changes from pre- to post-treatment on all outcome variables, controlling for baseline differences between dropouts and completers. Significant predictors of treatment response will be entered into a multivariate model to identify unique effects. Two analyses will be conducted for all outcome measures: (1) an intent-to-treat (ITT) analysis with all program starters and (2) a sensitivity analysis for core module completers only. For sensitivity analyses, repeated measures ANOVAs will used to test the effect of program completion over time on all outcome variables, with Bonferroni-adjusted confidence intervals for pairwise comparisons [baseline (T1) vs., post-core module completion (T3), T1 vs. 3-month follow-up (T6), T3 vs. T5]. Additionally, paired sample t-tests will be used to further explore program completion effects on subscales of outcome variables and self-reported knowledge, willingness and confidence assessed at T2, with Cohen’s D measure of effect size calculated for all significant results.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/04/2023
Actual
Date of last participant enrolment
Anticipated
31/10/2023
Actual
Date of last data collection
Anticipated
31/03/2024
Actual
Sample size
Target
73
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 312896 0
University
Name [1] 312896 0
InsideOut Institute for Eating Disorders
Country [1] 312896 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Sydney Local Health District
83 Missenden Road,
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 314574 0
None
Name [1] 314574 0
Address [1] 314574 0
Country [1] 314574 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312172 0
Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 312172 0
Research Ethics and Governance Office (REGO)
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 312172 0
Australia
Date submitted for ethics approval [1] 312172 0
01/12/2022
Approval date [1] 312172 0
24/02/2023
Ethics approval number [1] 312172 0
X22-0396 & 2022/ETH02591

Summary
Brief summary
The current study aims to evaluate a recently developed online, skills-based educational tool, SkillED. The proposed program has been specifically developed to provide psychoeducation and motivation for individuals with a clinical or subclinical diagnoses of an eating disorder. Overall, we aim to investigate:
(1) Program Effectiveness and Safety: The changes in participants’ eating disorder symptomology, general mental health, quality of life, self-perceived skill-level, understanding, knowledge and confidence in eating disorders and the motivation to seek help/treatment, in addition to self-harm and suicidal risk assessment and self-reported weight changes.

(2) Program Evaluation: The extent to which participants find the program content and delivery format acceptable and useful, with identification of areas of improvement and consideration to the broader feasibility of online skill-based programs for individuals with an ED across the diagnostic spectrum.

We anticipate that engagement with SkillED will result in improvements in eating disorder symptoms, overall wellbeing, knowledge and confidence in understanding of eating disorders, and increase motivation to seek treatment and actual help-seeking behaviours.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123726 0
A/Prof Sarah Maguire
Address 123726 0
InsideOut Institute for Eating Disorders,
The University of Sydney, Level 2, The Charles Perkins Centre, D17 John Hopkins Dr, Camperdown NSW 2006, Australia
Country 123726 0
Australia
Phone 123726 0
+61286271910
Fax 123726 0
Email 123726 0
sarah.maguire@sydney.edu.au
Contact person for public queries
Name 123727 0
Dr Shu Hwa Ong
Address 123727 0
InsideOut Institute for Eating Disorders,
The University of Sydney, Level 2, The Charles Perkins Centre, D17 John Hopkins Dr, Camperdown NSW 2006, Australia
Country 123727 0
Australia
Phone 123727 0
+61 286275690
Fax 123727 0
Email 123727 0
insideout.research@sydney.edu.au
Contact person for scientific queries
Name 123728 0
Dr Sarah Barakat
Address 123728 0
InsideOut Institute for Eating Disorders,
The University of Sydney, Level 2, The Charles Perkins Centre, D17 John Hopkins Dr, Camperdown NSW 2006, Australia
Country 123728 0
Australia
Phone 123728 0
+61 286275690
Fax 123728 0
Email 123728 0
sarah.barakat@sydney.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
Sensitive and confidential information on the implication use of our newly developed online education program in view of the copyright content of our program that is currently undergoing review for trial purpose


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18022Ethical approval    385167-(Uploaded-24-02-2023-21-11-21)-Study-related document.pdf



Results publications and other study-related documents

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