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Trial registered on ANZCTR
Registration number
ACTRN12621000914864
Ethics application status
Approved
Date submitted
3/06/2021
Date registered
14/07/2021
Date last updated
14/07/2021
Date data sharing statement initially provided
14/07/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Digital mental health interventions for recurrent binge eating
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Scientific title
Efficacy of internet- and app-based interventions for recurrent binge eating. A three-armed randomized controlled trial.
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Secondary ID [1]
304394
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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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Binge eating
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Condition category
Condition code
Mental Health
319878
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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
There will be two digital interventions delivered in this trial.
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 CBT (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; 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.
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Intervention code [1]
320754
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Treatment: Other
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Intervention code [2]
320969
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Behaviour
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Comparator / control treatment
The control condition will be a wait-list. Participants allocated to the waitlist will be notified that they can receive one of two of the digital interventions at post-test (4 weeks from baseline).
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Eating disorder psychopathology (global scores from the Eating Disorder Examination Questionnaire)
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Assessment method [1]
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Timepoint [1]
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Primary time-point (post-test) = 4 weeks after randomization.
Follow-up time-point = 8 weeks after randomization.
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Primary outcome [2]
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Objective binge eating frequency over the past 28 days (assessed via a single item from the EDE-Q).
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Assessment method [2]
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Timepoint [2]
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Primary time-point (post-test) = 4 weeks after randomization.
Follow-up time-point = 8 weeks after randomization.
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Secondary outcome [1]
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Dietary restraint (EDE-Q subscale)
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Assessment method [1]
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Timepoint [1]
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4 weeks after randomization.
8 weeks after randomization.
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Secondary outcome [2]
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shape concerns (EDE-Q subscale)
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Assessment method [2]
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Timepoint [2]
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4 weeks after randomization.
8 weeks after randomization.
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Secondary outcome [3]
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Weight concerns (EDE-Q subscale)
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Assessment method [3]
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Timepoint [3]
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4 weeks after randomization.
8 weeks after randomization.
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Secondary outcome [4]
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Eating concerns (EDE-Q subscale)
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Assessment method [4]
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Timepoint [4]
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4 weeks after randomization.
8 weeks after randomization.
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Secondary outcome [5]
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Subjective binge eating frequency (single EDE-Q item)
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Assessment method [5]
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Timepoint [5]
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4 weeks after randomization.
8 weeks after randomization.
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Secondary outcome [6]
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Depressive symptoms (PHQ-2)
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Assessment method [6]
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Timepoint [6]
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4 weeks after randomization.
8 weeks after randomization.
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Secondary outcome [7]
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Anxiety symptoms (PHQ-2)
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Assessment method [7]
396441
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Timepoint [7]
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4 weeks after randomization.
8 weeks after randomization.
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Secondary outcome [8]
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Body image flexibility (BIAAQ-4)
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Assessment method [8]
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Timepoint [8]
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4 weeks after randomization.
8 weeks after randomization.
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Secondary outcome [9]
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Body appreciation (BAS-2 3-item version)
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Assessment method [9]
396443
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Timepoint [9]
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4 weeks after randomization.
8 weeks after randomization.
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Secondary outcome [10]
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Functionality appreciation (FAS-7)
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Assessment method [10]
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Timepoint [10]
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4 weeks after randomization.
8 weeks after randomization.
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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.
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Minimum age
18
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
No other exclusion criteria will be employed.
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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)
Researchers will not be aware of any upcoming assignments as the randomisation process will be done completely online via Qualtrics.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will be performed via Qualtrics' randomisation function.
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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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
Not yet recruiting
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Date of first participant enrolment
Anticipated
2/08/2021
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Actual
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Date of last participant enrolment
Anticipated
9/08/2021
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Actual
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Date of last data collection
Anticipated
9/10/2021
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Actual
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Sample size
Target
420
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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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Deakin University
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Address [1]
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221 Burwood Hwy, Burwood VIC 3125
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Country [1]
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Australia
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Funding source category [2]
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Government body
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Name [2]
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NHMRC
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Address [2]
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National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
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Country [2]
308766
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Australia
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Primary sponsor type
University
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Name
Deakin University
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Address
221 Burwood Hwy, Burwood VIC 3125
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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]
309667
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Address [1]
309667
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Country [1]
309667
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
308679
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Deakin University Human Research Ethics Committee
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Ethics committee address [1]
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221 Burwood Hwy, Burwood VIC 3125
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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14/01/2021
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Approval date [1]
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29/04/2021
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Ethics approval number [1]
308679
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Summary
Brief summary
The present study will evaluate the relative efficacy of two digital interventions for recurrent binge eating: a smartphone app and an Internet-based program. The relative efficacy of different technology mediums has yet to be explored. Findings will shed light towards possible technologies that afford an added benefit.
The following hypotheses are derived:
1. Participants randomized to the two digital intervention groups will experience greater reductions in primary and secondary outcomes than participants randomized to the waitlist.
2. There will be no differences in outcome variables between those randomized to one of the two digital interventions (app versus web program).
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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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Dr Jake Linardon
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Address
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Deakin University, Faculty of Health, School of Psychology
221 Burwood Hwy, Burwood VIC 3125
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Country
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Australia
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Phone
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+61421666585
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Fax
111534
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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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Dr Jake Linardon
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Address
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Deakin University, Faculty of Health, School of Psychology
221 Burwood Hwy, Burwood VIC 3125
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Country
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Australia
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Phone
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+61421666585
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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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Dr Jake Linardon
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Address
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Deakin University, Faculty of Health, School of Psychology
221 Burwood Hwy, Burwood VIC 3125
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Country
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Australia
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Phone
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+61421666585
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Fax
111536
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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
Do not have ethical clearance.
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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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