Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001054808
Ethics application status
Approved
Date submitted
25/06/2021
Date registered
10/08/2021
Date last updated
10/08/2021
Date data sharing statement initially provided
10/08/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The acceptance of digital mental mental health interventions for binge eating
Scientific title
The acceptance of digital mental health interventions for recurrent binge eating. A randomized controlled trial.
Secondary ID [1] 304621 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is a sub-study of a larger 3 armed randomized controlled trial of digital interventions for binge eating. This larger trial has been pre-registered - ACTRN12621000914864

Health condition
Health condition(s) or problem(s) studied:
eating disorder 322542 0
binge eating 322543 0
Condition category
Condition code
Mental Health 320171 320171 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention administered in this study is called an acceptance-facilitated intervention (AFI).The AFI consists of a 5-8 min video in which the Investigator's provide information about digital mental health interventions for binge eating, with the intention of positively influencing clients' acceptance of these intervention modalities. The AFI content is based on the assumptions of the Unified Theory of Acceptance of Technology and the evidence on barriers of acceptance. The information presented consists of evidence for the effectiveness of digital interventions for binge eating, data security and anonymity concerning digital interventions, the broad range of advantages (e.g., flexibility, cost-effective etc.), and the potential to receive technical support. The intervention will also address many barriers towards digital health uptake, including data safety, internet anxiety, and skepticism regarding their use. In this AFI video, participants will be provided with instructions on how best to use and access digital interventions, including how to login and set a secure password.

The video will be embedded within the Qualtrics platform. In particular, after participants are randomized to this AFI, the video will be presented on the subsequent webpage. Participants merely click on it to watch it. To know whether participants watched the video as instructed, participants will be told prior to the video that 3 multiple choice questions will be asked of them about the video. These "attention check" questions will be very simple and each one will be asked in relation to distinct aspects of the video (e.g., mins 1-2, mins 3-4, then mins 5-6).
No other measures of adherence will be applied.

After participants complete the AFI video and the measures, they will be prescribed one of two digital interventions (per the pre-registered trial - ACTRN12621000914864).

The first will be a internet-based intervention designed to primarily target extreme dietary restraint as the mechanism to reduce binge eating.
The internet intervention is composed of 4 sessions.
1. Psycho-education: information on what dieting means, when it can become harmful, and why it can promote binge eating.
2. Self-monitoring: the importance of monitoring behaviors, thoughts, and emotions related to food, eating, and dieting
3. Regular eating: participants taught how to adopt a pattern of regular, flexible eating approach.
4. Food exposure: participants are taught how to overcome fear and anxiety around "forbidden" foods.

The second digital intervention will be delivered only via a smartphone app. The app is based on transdiagnostic cognitive-behavioral therapy (Fairburn, 2008) in that it is designed to target a range of factors implicated in the maintenance of binge eating (e.g., overvaluation with weight/shape, extreme dietary restraint & mood intolerance).

There are also 4 modules to this app:
1. Psychoeducation about binge eating and its cycle
2. Implementing self-monitoring and regular eating
3. Learning healthy coping strategies through acceptance, mindfulness, and problem solving
4. Building a better body image

Each session/module of the two interventions will take around 30-60 minutes to complete, and participants will be encouraged to practice the strategies taught in each session on a daily basis. Therefore, total time commitment will vary from person to person. Participants will be encouraged to stay on each session for around 7 days prior to moving to the next session, although they will be instructed that they can go at a pace that suits themselves. The total duration of the interventions will be 4 weeks, though participants have the opportunity to continue using the interventions after this period.

Each session/module will include: written text, quizzes/ interactive video or audio recordings discussing the content of the session and how to implement the prescribed strategies; downloadable handouts to complete the prescribed activities (created for the purpose of this study); and quizzes designed to consolidate learning.

Adherence will be monitored by assessing whether participants complete each of the sessions/modules, including how much of the session/module will be completed. This will be extracted from the platforms used to host the two digital interventions.

Intervention code [1] 320972 0
Behaviour
Comparator / control treatment
The control group will be an assessment-only group, in which participants will not be exposed to the AFI.
Control group
Active

Outcomes
Primary outcome [1] 328055 0
4-item Acceptance of Internet Interventions Scale (Ebert et al., 2015)
Timepoint [1] 328055 0
Immediately after the 5 min AFI video
Secondary outcome [1] 397367 0
Performance expectancy scale (4-items; Ebert et al., 2015)
Timepoint [1] 397367 0
Immediately after the 5 min AFI video
Secondary outcome [2] 397368 0
Effort expectancy scale (3-items; Ebert et al 2015).
Timepoint [2] 397368 0
Immediately after the 5 min AFI video
Secondary outcome [3] 397369 0
Social influence scale (4-items; Ebert et al., 2015)
Timepoint [3] 397369 0
Immediately after the 5 min AFI video
Secondary outcome [4] 397370 0
Facilitating conditions scale (3-items; Ebert et al., 2015)
Timepoint [4] 397370 0
Immediately after the 5 min AFI video
Secondary outcome [5] 397371 0
Internet anxiety scale (2-items; Ebert et al., 2015)
Timepoint [5] 397371 0
Immediately after the 5 min AFI video
Secondary outcome [6] 397372 0
Concerns regarding data security scale (2-items; Ebert et al., 2015)
Timepoint [6] 397372 0
Immediately after the 5 min AFI video
Secondary outcome [7] 397373 0
Single, self-created motivation level item
Timepoint [7] 397373 0
Immediately after the 5 min AFI video
Secondary outcome [8] 397374 0
Single, self-created intervention modality preference item
Timepoint [8] 397374 0
Immediately after the 5 min AFI video
Secondary outcome [9] 397375 0
Attitudes Towards Online Psychological Interventions Scale (16-items; Schroder et al., 2015).
Timepoint [9] 397375 0
Immediately after the 5 min AFI video
Secondary outcome [10] 397376 0
Digital intervention uptake (defined as whether the participant logged in at least one to a digital intervention offered to them after the video presentation, assessed via the analytics function offered by the platforms used to host the digital intervention).
Timepoint [10] 397376 0
4 weeks after the presentation of the video.
Secondary outcome [11] 397377 0
Digital intervention engagement (defined as [1] at least 50% of intervention content completed, [2] number of days having accessed the intervention, and [3] number of modules accessed). These composite engagement indices will be assessed via the web- and app-portal analytics that are offered in the corresponding platforms used to host the intervention.
Timepoint [11] 397377 0
4 weeks after the presentation of the video.
Secondary outcome [12] 397379 0
EDE-Q global scores
Timepoint [12] 397379 0
4 weeks after the presentation of the video.
Secondary outcome [13] 398176 0
Objective binge eating frequency over the past 28 days, defined by a single item from the Eating Disorder Examination Questionnaire (EDE-Q; Fairburn & Beglin, 1999).
Timepoint [13] 398176 0
4 weeks after the presentation of the video.

Eligibility
Key inclusion criteria
Participants must:
1) Be aged 18 years or over
2) Have access to the internet or smartphone
3) Experience the presence of recurrent binge eating, defined as binge eating at least once per fortnight, on average, over the past 3 months via self-report.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No other exclusion criteria will be employed.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Researchers will not be aware of any upcoming assignments as the randomisation process will be done completely online via Qualtrics.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will be performed via Qualtrics' randomisation function.
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/08/2021
Date of last participant enrolment
Anticipated
27/08/2021
Actual
Date of last data collection
Anticipated
29/10/2021
Actual
Sample size
Target
280
Accrual to date
230
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 308981 0
University
Name [1] 308981 0
Deakin University
Country [1] 308981 0
Australia
Funding source category [2] 308982 0
Government body
Name [2] 308982 0
NHMRC
Country [2] 308982 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Hwy, Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 309917 0
None
Name [1] 309917 0
Address [1] 309917 0
Country [1] 309917 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308873 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 308873 0
Ethics committee country [1] 308873 0
Australia
Date submitted for ethics approval [1] 308873 0
14/01/2021
Approval date [1] 308873 0
29/04/2021
Ethics approval number [1] 308873 0

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

Contacts
Principal investigator
Name 112178 0
Dr Jake Linardon
Address 112178 0
Deakin University, Faculty of Health, School of Psychology
221 Burwood Hwy, Burwood VIC 3125
Country 112178 0
Australia
Phone 112178 0
+61421666585
Fax 112178 0
Email 112178 0
[email protected]
Contact person for public queries
Name 112179 0
Jake Linardon
Address 112179 0
Deakin University, Faculty of Health, School of Psychology
221 Burwood Hwy, Burwood VIC 3125
Country 112179 0
Australia
Phone 112179 0
+61421666585
Fax 112179 0
Email 112179 0
[email protected]
Contact person for scientific queries
Name 112180 0
Jake Linardon
Address 112180 0
Deakin University, Faculty of Health, School of Psychology
221 Burwood Hwy, Burwood VIC 3125
Country 112180 0
Australia
Phone 112180 0
+61421666585
Fax 112180 0
Email 112180 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
We do not have ethical clearance.


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.