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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]

None

Universal Trial Number (UTN)

None

Trial acronym

SkillED

Linked study record

None

Health condition

Health condition(s) or problem(s) studied:

Eating disorders

Condition category

Condition code

Mental Health

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]

Treatment: Other

Comparator / control treatment

No Control Group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Eating symptomology of participants by the change on the global Eating Disorder Examination Questionnaire (EDE-Q)

Timepoint [1]

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]

Change on behavioural items of the EDE-Q

Timepoint [1]

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]

General mental health and quality of life of participants by change on the Depression, Anxiety and Stress Scale-21 (DASS-21)

Timepoint [2]

Secondary outcome [3]

Eating Disorder Stage of Change

Timepoint [3]

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]

Participant usage of SkillED modules via software usage analytics

Timepoint [4]

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]

Brief pre-post module acceptability and feasibility questions on a 5-point Likert scale

Timepoint [5]

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]

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]

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]

Motivation to engage with treatment by Adapted General Help-Seeking Questionnaire

Timepoint [7]

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]

Dropout rates and reasons for dropout reported by participants

Timepoint [8]

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]

USE (Usability, Satisfaction, and Ease of Use) questionnaire

Timepoint [9]

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]

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]

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]

To assess the safety of SkillED program by Self-harm assessment

Timepoint [11]

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]

To assess the safety of SkillED by monitoring self-reported weight of the participants

Timepoint [12]

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]

To assess the safety of SkillED program by suicidal risk assessment

Timepoint [13]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

InsideOut Institute for Eating Disorders

Address [1]

InsideOut Institute for Eating Disorders,
The University of Sydney, Level 2, The Charles Perkins Centre, D17 John Hopkins Dr, Camperdown NSW 2006

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Local Health District Human Research Ethics Committee

Ethics committee address [1]

Research Ethics and Governance Office (REGO)
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/12/2022

Approval date [1]

24/02/2023

Ethics approval number [1]

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

A/Prof Sarah Maguire

Address

InsideOut Institute for Eating Disorders,
The University of Sydney, Level 2, The Charles Perkins Centre, D17 John Hopkins Dr, Camperdown NSW 2006, Australia

Country

Australia

Phone

+61286271910

Fax

[email protected]

Contact person for public queries

Name

Shu Hwa Ong

Address

InsideOut Institute for Eating Disorders,
The University of Sydney, Level 2, The Charles Perkins Centre, D17 John Hopkins Dr, Camperdown NSW 2006, Australia

Country

Australia

Phone

+61 286275690

Fax

[email protected]

Contact person for scientific queries

Name

Sarah Barakat

Address

InsideOut Institute for Eating Disorders,
The University of Sydney, Level 2, The Charles Perkins Centre, D17 John Hopkins Dr, Camperdown NSW 2006, Australia

Country

Australia

Phone

+61 286275690

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
18022	Ethical approval					385167-(Uploaded-24-02-2023-21-11-21)-Study-related document.pdf

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.

Trial Review

Documents added manually

Documents added automatically