Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001612808
Ethics application status
Approved
Date submitted
23/11/2021
Date registered
26/11/2021
Date last updated
22/11/2022
Date data sharing statement initially provided
26/11/2021
Date results provided
22/11/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Online eTherapy Program for Individuals with binge-eating disorder
Scientific title
Evaluating the acceptability and safety of a supported Cognitive Behavioural Therapy (CBT) eTherapy for binge-eating disorder: A single arm uncontrolled trial of Binge Eating eTherapy
Secondary ID [1] 305871 0
None
Universal Trial Number (UTN)
Trial acronym
BEeT (Binge Eating eTherapy) for BED
Linked study record
This record is a sub-study of ACTRN12619000123145.

Health condition
Health condition(s) or problem(s) studied:
Binge-Eating Disorder 324419 0
Condition category
Condition code
Mental Health 321916 321916 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Binge Eating eTherapy (BEeT) program consists of ten, one-hour interactive, multi-media sessions developed by clinicians at the InsideOut Institute. BEeT is a Cognitive-Behavioural Therapy (CBT) program with all core components of CBT demonstrated effective in eating disorders, including establishing regular eating according to the “three-hour rule” and self-monitoring, thought challenging and feared food exposure. 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 ten week period. The program also includes interactives exploring key skills in CBT, an inbuilt Food Monitoring, Behaviour Monitoring, Food Planner, Thought Challenge, and Exposure Tool. 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.

Supported self-help BEeT (SSH-BEeT): Participants complete 10 sessions of BEeT in conjunction to 10 weekly x 30 min face-to-face contact sessions with trained clinician across 12 weeks. The clinicians involved will be those employed at NSW Local Health District Community Mental Health Teams or headspace centres. Training of clinicians in the delivery of 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 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] 322268 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329660 0
Eating Disorder Examination Questionnaire (EDE-Q)
Timepoint [1] 329660 0
Baseline, post-treatment (12 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] 403336 0
Kessler Psychological Distress Scale (K10)
Timepoint [1] 403336 0
Baseline, post-treatment (12 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] 403337 0
The European Quality of Life - 5 dimensions - 5 levels (ED-5D-5L)
Timepoint [2] 403337 0
Baseline, post-treatment (12 weeks after intervention commencement) and follow-up (12 weeks after post-treatment assessment).
Secondary outcome [3] 403338 0
Three Factor Eating Questionnaire (TFEQ)
Timepoint [3] 403338 0
Baseline, post-treatment (12 weeks after intervention commencement) and follow-up (12 weeks after post-treatment assessment).
Secondary outcome [4] 403339 0
Adherence: Dropout rates (number of participants who complete the post-treatment assessment) 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] 403339 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.

Eligibility
Key inclusion criteria
• Greater than or equal to 16 years of age
• Meets DSM-5 criteria for Binge-Eating Disorder (BED) OR Other Specified Feeding or Eating Disorder (with BED Behaviours) at least once per week for previous 2 months: engaged in objective binge episodes at least once per week in the preceding 2 months from when questionnaire was taken.
• BMI greater than or equal to 19
• Access to internet
Minimum age
16 Years
Maximum age
No limit
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
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 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
Completed
Date of first participant enrolment
Anticipated
Actual
3/05/2021
Date of last participant enrolment
Anticipated
Actual
30/07/2021
Date of last data collection
Anticipated
25/02/2022
Actual
17/12/2021
Sample size
Target
25
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 310222 0
Government body
Name [1] 310222 0
NSW Health Translational Research Grants Scheme (TRGS)
Country [1] 310222 0
Australia
Primary sponsor type
University
Name
InsideOut Institute of Eating Disorders within the Boden Institute of Obesity, Nutrition, Exercise and 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] 311319 0
None
Name [1] 311319 0
Address [1] 311319 0
Country [1] 311319 0
Other collaborator category [1] 282076 0
University
Name [1] 282076 0
Deakin University
Address [1] 282076 0
221 Burwood Highway, Burwood, Victoria 3125
Country [1] 282076 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309905 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 309905 0
Ethics committee country [1] 309905 0
Australia
Date submitted for ethics approval [1] 309905 0
22/02/2021
Approval date [1] 309905 0
23/03/2021
Ethics approval number [1] 309905 0
X18-0486 & 2019/ETH12146 9.63/MAR21
Ethics committee name [2] 309906 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [2] 309906 0
Ethics committee country [2] 309906 0
Australia
Date submitted for ethics approval [2] 309906 0
12/04/2021
Approval date [2] 309906 0
16/04/2021
Ethics approval number [2] 309906 0
2021-145

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115786 0
Dr Sarah Maguire
Address 115786 0
InsideOut Institute for Eating Disorders Boden Institute of Obesity, Nutrition, Exercise and 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 115786 0
Australia
Phone 115786 0
+61 425284611
Fax 115786 0
Email 115786 0
[email protected]
Contact person for public queries
Name 115787 0
Sean Rom
Address 115787 0
InsideOut Institute for Eating Disorders Boden Institute of Obesity, Nutrition, Exercise and 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 115787 0
Australia
Phone 115787 0
+61 415231655
Fax 115787 0
Email 115787 0
[email protected]
Contact person for scientific queries
Name 115788 0
Sean Rom
Address 115788 0
InsideOut Institute for Eating Disorders Boden Institute of Obesity, Nutrition, Exercise and 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 115788 0
Australia
Phone 115788 0
+61 415231655
Fax 115788 0
Email 115788 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseEvaluating the feasibility and potential efficacy of a brief eTherapy for binge-eating disorder: A pilot study.2022https://dx.doi.org/10.1002/eat.23803
EmbaseThe acceptability, feasibility, and preliminary efficacy of a supported online self-help treatment program for binge-eating disorder.2023https://dx.doi.org/10.3389/fpsyt.2023.1229261
N.B. These documents automatically identified may not have been verified by the study sponsor.