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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
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Scientific title
The impacts of a single session educational chatbot on eating disorder symptoms in people on waitlists for treatment
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Secondary ID [1]
309801
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Eating Disorders
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Condition category
Condition code
Mental Health
327079
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0
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Eating disorders
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Intervention/exposure
Study type
Interventional
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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).
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Intervention code [1]
326230
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Treatment: Other
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Change in eating disorder symptoms assessed by the global score on the Eating Disorder Examination Questionnaire (EDE-Q).
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Assessment method [1]
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Timepoint [1]
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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).
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Secondary outcome [1]
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Change in overall mental health assessed by The Depression Anxiety and Stress Scale - 21 items (DASS-21)
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Assessment method [1]
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Timepoint [1]
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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)
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Secondary outcome [2]
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Change in psychosocial impairment due to eating disorder symptoms assessed by the Clinical Impairment Assessment questionnaire (CIA)
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Assessment method [2]
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Timepoint [2]
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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)
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Secondary outcome [3]
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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)
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Assessment method [3]
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Timepoint [3]
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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)
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Eligibility
Key inclusion criteria
On the waitlist for eating disorder treatment
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
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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)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
Not applicable
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
14/07/2023
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Actual
7/09/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
100
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Accrual to date
12
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Monash University
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Address [1]
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Alfred Centre, 99 Commerical Road, Melbourne, VIC 3004
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Monash University
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Address
Alfred Centre, 99 Commerical Road, Melbourne, VIC 3004
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
315868
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Country [1]
315868
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
313121
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Monash University Human Research Ethics Committee
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Ethics committee address [1]
313121
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Research Office, Monash University
Room 111, Chancellery Building D,
26 Sports Walk, Clayton Campus
VIC 3800
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Ethics committee country [1]
313121
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Australia
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Date submitted for ethics approval [1]
313121
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26/05/2023
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Approval date [1]
313121
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27/06/2023
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Ethics approval number [1]
313121
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38277
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Gemma Sharp
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Address
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Monash University, The Alfred Centre, Level 5, 99 Commerical Road, Melbourne, VIC, 3004
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Country
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Australia
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Phone
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+610399038262
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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A/Prof Gemma Sharp
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Address
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Monash University, The Alfred Centre, Level 5, 99 Commerical Road, Melbourne, VIC, 3004
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Country
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Australia
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Phone
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+610399038262
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Gemma Sharp
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Address
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Monash University, The Alfred Centre, Level 5, 99 Commerical Road, Melbourne, VIC, 3004
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Country
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Australia
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Phone
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+610399038262
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Fax
127072
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
The research team would prefer to maintain the privacy of the research participants.
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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.
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