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Trial registered on ANZCTR


Registration number
ACTRN12623000680662
Ethics application status
Approved
Date submitted
8/06/2023
Date registered
23/06/2023
Date last updated
14/01/2024
Date data sharing statement initially provided
23/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The impacts of a single session educational chatbot on people on waitlists for eating disorder treatment
Scientific title
The impacts of a single session educational chatbot on eating disorder symptoms in people on waitlists for treatment
Secondary ID [1] 309801 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eating Disorders 330213 0
Condition category
Condition code
Mental Health 327079 327079 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An online Single Session Educational Program (SSEP) delivered by a chabot for waitlisted clients seeking eating disorder treatment.

Participants will be randomised into the intervention group or control group. Participants in the intervention group will have access to a 30-minute online SSEP delivered by a chatbot. This will be accessed through a password protected login on a website. The SSEP is based on the single session intervention described by Fursland et al. (2018).

The SSEP focuses on assessment of eating disorder symptoms and providing psychoeducation to the user. Psychoeducation includes information about starvation syndrome and the maintenance cycle of eating disorders which is conducted through interactive activities and short videos. The aim of the SSEP is to provide short term treatment for participants and offer them information so the participant can gain a deeper understanding of their experiences. Participants will complete the SSEP once and they will have on-going access to a summary of the session and material. Upon completion, the participants in the intervention group will complete a post-intervention survey. Analysis of website analytics will be conducted to monitor adherence to the intervention.

Participants will be assessed at baseline, 2-4-weeks, and 3-4 months post-randomisation (the latter representing when the participant has completed the first in-person session of their eating disorder treatment with a psychologist).
Intervention code [1] 326230 0
Treatment: Other
Comparator / control treatment
Participants randomised into the control group will experience the typical treatment for waitlist clients, which is no treatment. The control group will not have access to the single session educational chatbot.
Control group
Active

Outcomes
Primary outcome [1] 334948 0
Change in eating disorder symptoms assessed by the global score on the Eating Disorder Examination Questionnaire (EDE-Q).
Timepoint [1] 334948 0
Outcomes will be measured at baseline, at the 2–4-week post-baseline follow-up, and at the 3–4-month post-baseline follow-up (primary time point; after the participant has completed the first session of their treatment in-person with a psychologist).
Secondary outcome [1] 422507 0
Change in overall mental health assessed by The Depression Anxiety and Stress Scale - 21 items (DASS-21)
Timepoint [1] 422507 0
Outcomes will be measured at baseline, at the 2–4-week post-baseline follow-up, and at the 3–4-month post-baseline follow-up (after the participant has completed the first session of their treatment in-person with a psychologist)
Secondary outcome [2] 422508 0
Change in psychosocial impairment due to eating disorder symptoms assessed by the Clinical Impairment Assessment questionnaire (CIA)
Timepoint [2] 422508 0
Outcomes will be measured at baseline, at the 2–4-week post-baseline follow-up, and at the 3–4-month post-baseline follow-up (after the participant has completed the first session of their treatment in-person with a psychologist)
Secondary outcome [3] 422509 0
Change in motivation for treatment, assessed by visual analogue scales based on the motivational questions in A Cognitive Interpersonal Therapy Workbook for Treating Anorexia Nervosa: A Maudsley Model (Schmidt et al., 2018)
Timepoint [3] 422509 0
Outcomes will be measured at baseline, at the 2–4-week post-baseline follow-up, and at the 3–4-month post-baseline follow-up (after the participant has completed the first session of their treatment in-person with a psychologist)

Eligibility
Key inclusion criteria
On the waitlist for eating disorder treatment
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria includes no access to a working email address and electronic device, and high medical and/or psychiatric risk (as assessed and documented by the general practitioner as a standard part of any referral to an eating disorder focused psychology clinic)
- Participants who screen positive for Avoidant Restriction Food Intake Disorder (ARFID) at baseline will be excluded from the study.

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 is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by a computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/07/2023
Actual
7/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313984 0
University
Name [1] 313984 0
Monash University
Country [1] 313984 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Alfred Centre, 99 Commerical Road, Melbourne, VIC 3004
Country
Australia
Secondary sponsor category [1] 315868 0
None
Name [1] 315868 0
Address [1] 315868 0
Country [1] 315868 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313121 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 313121 0
Research Office, Monash University
Room 111, Chancellery Building D,
26 Sports Walk, Clayton Campus
VIC 3800
Ethics committee country [1] 313121 0
Australia
Date submitted for ethics approval [1] 313121 0
26/05/2023
Approval date [1] 313121 0
27/06/2023
Ethics approval number [1] 313121 0
38277

Summary
Brief summary
In-person single session educational programs (SSEP) have been suggested as a solution for short-term treatment for people on the waitlist for eating disorder treatment. However, these programs are resource-intensive, as they are usually delivered by an experienced clinician. To overcome this barrier. We have developed and preliminarily validated a rule-based chatbot (a computer program that uses artificial intelligence to have human-like conversations) to deliver elements of the SSEP. The current randomised control trial aims to evaluate the effectiveness of an online single session educational program (SSEP) delivered by a chatbot for people aged 16 and above on the waitlist for eating disorder treatment in Australia. It is hypothesized that participants who engage with the online SSEP will experience improvements in their eating disorder symptoms, overall mental health, psychosocial impairment due to eating disorder symptoms, and motivation for treatment, compared to participants who receive no treatment while on the waitlist.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127070 0
A/Prof Gemma Sharp
Address 127070 0
Monash University, The Alfred Centre, Level 5, 99 Commerical Road, Melbourne, VIC, 3004
Country 127070 0
Australia
Phone 127070 0
+610399038262
Fax 127070 0
Email 127070 0
gemma.sharp@monash.edu
Contact person for public queries
Name 127071 0
A/Prof Gemma Sharp
Address 127071 0
Monash University, The Alfred Centre, Level 5, 99 Commerical Road, Melbourne, VIC, 3004
Country 127071 0
Australia
Phone 127071 0
+610399038262
Fax 127071 0
Email 127071 0
gemma.sharp@monash.edu
Contact person for scientific queries
Name 127072 0
A/Prof Gemma Sharp
Address 127072 0
Monash University, The Alfred Centre, Level 5, 99 Commerical Road, Melbourne, VIC, 3004
Country 127072 0
Australia
Phone 127072 0
+610399038262
Fax 127072 0
Email 127072 0
gemma.sharp@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The research team would prefer to maintain the privacy of the research participants.


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.