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Trial registered on ANZCTR


Registration number
ACTRN12622000062729
Ethics application status
Approved
Date submitted
13/12/2021
Date registered
20/01/2022
Date last updated
20/01/2022
Date data sharing statement initially provided
20/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Brief Online eTherapy Program for Individuals with Binge-Eating Disorder or Bulimia Nervosa
Scientific title
Evaluating the acceptability and safety of a brief supported Cognitive Behavioural Therapy (CBT) eTherapy for binge-eating disorder and bulimia nervosa: A single arm uncontrolled trial of Brief Binge Eating eTherapy
Secondary ID [1] 306032 0
None
Universal Trial Number (UTN)
Trial acronym
Brief BEeT (Binge-Eating eTherapy) for BED and BN
Linked study record
This record is a sub-study of ACTRN12619000123145.

Health condition
Health condition(s) or problem(s) studied:
Bulimia Nervosa 324667 0
Binge-Eating Disorder 324668 0
Mental Health 324669 0
Condition category
Condition code
Mental Health 322117 322117 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Brief Binge Eating eTherapy (BEeT) program consists of four, one-hour interactive, multi-media sessions developed by clinicians at the InsideOut Institute. Brief BEeT is a Cognitive-Behavioural Therapy (CBT) program with the core behavioural components of CBT demonstrated effective in eating disorders, including establishing regular eating according to the “three-hour rule” and self-monitoring. BEeT is delivered by a live action therapist (i.e. a recorded video of a therapist delivering the key components of the program). Participants will be instructed to complete one x 60 minute module per week across a six week period. The program also includes interactives exploring key skills in CBT, an inbuilt Food Monitoring, Behaviour Monitoring, and Food Planner. The program sends a daily SMS to participants’ mobile phones at approximately 9 a.m. as a reminder to record their meals using the Food Diary tool throughout the day. An additional evening SMS is sent at approximately 6 p.m. to participants who had not completed a Food Diary entry for the preceding two days to prompt re-engagement.

Brief Supported self-help BEeT (Brief SSH-BEeT): Participants complete 4 sessions of BEeT in conjunction to 5 weekly x 30 min face-to-face contact sessions with trained clinician across 6 weeks. The clinicians involved will be those employed at the University of Sydney at the InsideOut Institute for Eating Disorders. Training of clinicians in the delivery of Brief SSH-BEeT will be provided via an online program and face-to-face training sessions. The weekly contact sessions with clinicians is not intended to serve an additional therapy, rather will involve supporting the participant through their use of Brief BEeT. Accordingly each face-to-face session will have the following structure: general check-in, review of the previous BEeT session and associated homework tasks with particular focus and debrief of specific self-monitoring exercises, review weekly weigh-in and preparation for completion of next BEeT session and associated homework tasks.

Adherence to program content will be captured by the eTherapy system, which provides the rates of participant's completion of program content. Adherence will also be assessed by participant's use of the digital food diary, which is also captured by the eTherapy system. Finally, support session attendance is tracked within RedCap by individual support clinicians, who note participant presence at each scheduled meeting, with the time and date recorded.
Intervention code [1] 322431 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329885 0
Eating Disorder Examination Questionnaire (EDE-Q)
Timepoint [1] 329885 0
Baseline, post-treatment (6 weeks after intervention commencement) and follow-up (12 weeks after post-treatment assessment). This measure will assist in evaluating the safety of the program, by determining if eating disorder symptoms are significantly worsened by use of the intervention.
Secondary outcome [1] 404171 0
Kessler Psychological Distress Scale (K10)
Timepoint [1] 404171 0
Baseline, post-treatment (6 weeks after intervention commencement) and follow-up (12 weeks after post-treatment assessment). This measure will assist in evaluating the safety of the intervention by indicating if there is a significant increase in psychological distress at post-assessment.
Secondary outcome [2] 404172 0
The European Quality of Life - 5 dimensions - 5 levels (ED-5D-5L)
Timepoint [2] 404172 0
Baseline, post-treatment (6 weeks after intervention commencement) and follow-up (12 weeks after post-treatment assessment).
Secondary outcome [3] 404173 0
Three Factor Eating Questionnaire (TFEQ)
Timepoint [3] 404173 0
Baseline, post-treatment (6 weeks after intervention commencement) and follow-up (12 weeks after post-treatment assessment).
Secondary outcome [4] 404174 0
Adherence: Dropout rates (number of participants who complete the post-treatment assessment, assessed via audit of study records in RedCap where the pre/post-treatment assessment data is stored) and digital intervention access measures (i.e., log-in rates, number of intervention modules accessed or completed, the frequency of website visits per module, the frequency of access specific tools or features of the program--e.g., self-monitoring tools).
Timepoint [4] 404174 0
This adherence data will be evaluated at the completion of the study to assess adherence/compliance to the eTherapy program week to week, across participant's completion of the eTherapy program.
Secondary outcome [5] 405043 0
An item of the EDE-Q (see primary outcome measure) also requests participant's current BMI, which will be used two-fold: as a confirmatory safety measure to ensure adequate BMI for participation as per inclusion criteria, and as an secondary outcome measure to assess any significant change in BMI across the course of the intervention.
Timepoint [5] 405043 0
Baseline, post-treatment (6 weeks after intervention commencement) and follow-up (12 weeks after post-treatment assessment).

Eligibility
Key inclusion criteria
• Age range: 12-25 years old
• Meets DSM-5 criteria for Bulimia Nervosa (BN) OR Binge-Eating Disorder (BED) OR Other Specified Feeding or Eating Disorder (with BED or BN Behaviours) once per week or less for previous 2 months: engaged in objective binge episodes and/or inappropriate compensatory behaviours (inclusive of vomiting, excessive laxative or diuretic use, extreme exercise or severe dietary restriction) once per week or less in the preceding 2 months from when questionnaire was taken.
• BMI greater than or equal to 19
• Access to internet
Minimum age
12 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Currently engaged in ongoing CBT treatment
• Non-proficient English speakers
• Presence of serious medical instability
• Active suicidality or self-harm behaviours
• Severe psychiatric conditions that would interfere with treatment (e.g., psychosis)
• Pregnant or breast-feeding

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Complete case and multiple imputation analysis will be implemented in accordance with missingness assumptions that fit the data (missing at random vs missing not at random), followed by sensitivity analysis where appropriate. The primary outcome will be the change in objective binge episode frequency (measured by the EDE-Q). Secondary outcomes considered will be changes in all scores on the EDE-Q, K10, EDQOL, TFEQ and BMI.

Linear regression analysis and pairwise comparison will be used to analyse the effectiveness of Brief SSH-BEeT in reducing binge eating symptomology, using the change in pre to post objective binge episodes on the EDE-Q as the primary outcome.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/03/2022
Actual
Date of last participant enrolment
Anticipated
30/06/2023
Actual
Date of last data collection
Anticipated
11/08/2023
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 310371 0
Government body
Name [1] 310371 0
NSW Health Translational Research Grants Scheme (TRGS)
Country [1] 310371 0
Australia
Primary sponsor type
University
Name
InsideOut Institute of Eating Disorders at the University of Sydney
Address
Level 2, The Charles Perkins Centre, D17
The University of Sydney
Johns Hopkins Drive (off Missenden Road)
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 311508 0
None
Name [1] 311508 0
Address [1] 311508 0
Country [1] 311508 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310024 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 310024 0
Research Ethics and Governance Office (REGO) Royal Prince Alfred Hospital Missenden Road CAMPERDOWN NSW 2050
Ethics committee country [1] 310024 0
Australia
Date submitted for ethics approval [1] 310024 0
01/11/2021
Approval date [1] 310024 0
26/11/2021
Ethics approval number [1] 310024 0
2019/ETH12146(72697)

Summary
Brief summary
The study will evaluate the effectiveness of a new, brief interactive online Cognitive Behavioural Therapy program for individuals who experience difficulty with binge eating, named Brief Binge Eating eTherapy or Brief BEeT. Brief BEeT consists of four, one-hour interactive, multi-media sessions with the behavioural components of CBT demonstrated effective in eating disorders, including establishing regular eating according to the “three-hour rule” and self-monitoring. The study will examine whether engaging with Brief BEeT results in a significant decrease in individuals' binge eating in those with bulimia nervosa or binge-eating disorder.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116222 0
Dr Sarah Maguire
Address 116222 0
InsideOut Institute for Eating Disorders, Level 2, The Charles Perkins Centre, D17 The University of Sydney Johns Hopkins Drive (off Missenden Road) Camperdown NSW 2006 The University of Sydney
Country 116222 0
Australia
Phone 116222 0
+61 425284611
Fax 116222 0
Email 116222 0
sarah.maguire@sydney.edu.au
Contact person for public queries
Name 116223 0
Dr Sarah Maguire
Address 116223 0
InsideOut Institute for Eating Disorders, Level 2, The Charles Perkins Centre, D17 The University of Sydney Johns Hopkins Drive (off Missenden Road) Camperdown NSW 2006 The University of Sydney
Country 116223 0
Australia
Phone 116223 0
+61 425284611
Fax 116223 0
Email 116223 0
sarah.maguire@sydney.edu.au
Contact person for scientific queries
Name 116224 0
Dr Sarah Maguire
Address 116224 0
InsideOut Institute for Eating Disorders, Level 2, The Charles Perkins Centre, D17 The University of Sydney Johns Hopkins Drive (off Missenden Road) Camperdown NSW 2006 The University of Sydney
Country 116224 0
Australia
Phone 116224 0
+61 425284611
Fax 116224 0
Email 116224 0
sarah.maguire@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


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.