Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000123145
Ethics application status
Approved
Date submitted
22/01/2019
Date registered
29/01/2019
Date last updated
20/01/2022
Date data sharing statement initially provided
29/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Online eTherapy Program for Individuals with Bulimia Nervosa
Scientific title
Supported Online Cognitive Behavioural Therapy (CBT) for Bulimia Nervosa (BN): a multisite, randomised controlled trial of Binge Eating eTherapy
Secondary ID [1] 297180 0
None
Universal Trial Number (UTN)
U1111-1227-2627
Trial acronym
BEeT (Binge Eating eTherapy)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bulimia nervosa 311219 0
Condition category
Condition code
Mental Health 309845 309845 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.
This study will examine BEeT in a multisite, three-arm, randomised-controlled trial with the following three conditions:
1. Pure self-help BEeT (PSH-BEeT): Participants independently complete 10 sessions of BEeT across 12 weeks with 2 telephone contacts with research assistant to initiate pre and post assessment.
2. 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.
3. Waitlist control (WLC): Two telephone contacts with research assistant to initiate pre and post assessment. Participants in WLC will receive access to BEeT at end of 12 weeks.

Treatment outcome and treatment adherence will be assessed. Treatment outcome measures are described in further detail in Section 4. of the ANZCTR. Treatment adherence will be assessed by dropout rates as well as digital measures of user exposure to the intervention, such as log-in rates, number of intervention modules accessed or completed, the frequency of website visits per module, or the use of specific tools or features of the program--e.g., self-monitoring tools.
Intervention code [1] 313439 0
Treatment: Other
Comparator / control treatment
The control treatment will consist of a waitlist control condition. Participants in this condition will receive two telephone contacts with research assistant to initiate pre and post assessment. Participants in waitlist condition will be required to complete short weekly questionnaires (identical to those completed in the two treatment conditions) and they will receive access to BEeT at end of 12 weeks.
Control group
Active

Outcomes
Primary outcome [1] 318800 0
Eating Disorder Examination Questionnaire (EDE-Q)
Timepoint [1] 318800 0
Baseline, post-treatment (12 weeks after intervention commencement) and follow-up (12 weeks after post-treatment assessment).
Secondary outcome [1] 366079 0
Kessler Psychological Distress Scale (K10)
Timepoint [1] 366079 0
Baseline, post-treatment (12 weeks after intervention commencement) and follow-up (12 weeks after post-treatment assessment).
Secondary outcome [2] 366080 0
Eating Disorder Quality of Life Questionnaire (EDQOL)
Timepoint [2] 366080 0
Baseline, post-treatment (12 weeks after intervention commencement) and follow-up (12 weeks after post-treatment assessment).
Secondary outcome [3] 366081 0
The European Quality of Life - 5 dimensions - 5 levels (ED-5D-5L)
Timepoint [3] 366081 0
Baseline, post-treatment (12 weeks after intervention commencement) and follow-up (12 weeks after post-treatment assessment).
Secondary outcome [4] 366082 0
Three Factor Eating Questionnaire (TFEQ)
Timepoint [4] 366082 0
Baseline, post-treatment (12 weeks after intervention commencement) and follow-up (12 weeks after post-treatment assessment).
Secondary outcome [5] 366163 0
Adherence
Timepoint [5] 366163 0
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).

Eligibility
Key inclusion criteria
• Greater than or equal to 16 years of age
• Meets DSM-5 criteria for bulimia nervosa (BN; purging or non-purging type): engaged in objective binge episodes and inappropriate compensatory behaviours (inclusive of vomiting, excessive laxative or diuretic use, extreme exercise or severe dietary restriction) at least once per week in the preceding 28-days 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
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)
The randomisation allocation will be conducted by an independent researcher using an internet-based program. Block randomisation sequence will be implemented to ensure a balance in sample size across conditions over time.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Accounting for multiple comparisons in the testing procedure, an alpha or 0.05 was adjusted to 0.017 under Bonferroni method. Assuming an adjusted significance level of 0.017, a power of 0.95 and an effect size Cohen’s d = 0.34 in a one-way ANOVA study, a sample size of 58 participants is required in each of the three conditions. Accounting for the average dropout rate of 30% in online treatment programs for eating disorders, a total sample size of 75 participants per group will be recruited.

An intention to treat analysis will be conducted. 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 the change in EDE-Q scores. Secondary outcomes considered will be changes in scores on the K10, EDQOL, TFEQ and BMI. Analysis of variance (ANOVA) for RCT data will be used to compare the effectiveness of PSH-BEeT vs. SSH-BEeT vs. WLC, collapsed across settings, using EDE-Q change as the primary outcome. In a secondary analysis, participants will be titrated depending upon treatment setting and effectiveness of the program compared across settings, using a multilevel mixed effects model to determine if the main outcome is affected by the setting in which treatment is delivered. We will examine which baseline characteristics significantly impact CBT outcomes such as age, severity of illness, duration of eating disorder, setting, and expertise of clinician.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
15/06/2019
Actual
18/10/2019
Date of last participant enrolment
Anticipated
25/01/2021
Actual
1/10/2021
Date of last data collection
Anticipated
29/04/2022
Actual
Sample size
Target
225
Accrual to date
Final
225
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 301120 0
Government body
Name [1] 301120 0
NSW Health Translational Research Grants Scheme (TRGS)
Country [1] 301120 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] 301473 0
None
Name [1] 301473 0
Address [1] 301473 0
Country [1] 301473 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301870 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 301870 0
Ethics committee country [1] 301870 0
Australia
Date submitted for ethics approval [1] 301870 0
19/11/2018
Approval date [1] 301870 0
05/07/2019
Ethics approval number [1] 301870 0
Protocol No. X18-0486 & 2019/ETH12146

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

Contacts
Principal investigator
Name 88386 0
Dr Sarah Maguire
Address 88386 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 88386 0
Australia
Phone 88386 0
+61 425284611
Fax 88386 0
Email 88386 0
[email protected]
Contact person for public queries
Name 88387 0
Sarah Barakat
Address 88387 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 88387 0
Australia
Phone 88387 0
+61 422047689
Fax 88387 0
Email 88387 0
[email protected]
Contact person for scientific queries
Name 88388 0
Sarah Barakat
Address 88388 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 88388 0
Australia
Phone 88388 0
+61 422047689
Fax 88388 0
Email 88388 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
Given the highly personal and sensitive nature of the information collected from participants (e.g., regarding their health and personal contact details), all data and material collected for the study will be treated confidentially. All data will be securely stored on an online database via a secure website (firewall protected) which requires a pre-authorised login and password known only to the Chief Investigator (Dr. Sarah Maguire) or the Project Coordinator (Sarah Barakat).


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
EmbaseA randomised controlled trial of clinician supported vs self-help delivery of online cognitive behaviour therapy for Bulimia Nervosa.2023https://dx.doi.org/10.1016/j.psychres.2023.115534
N.B. These documents automatically identified may not have been verified by the study sponsor.