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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Date results information initially provided
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of a Stress Reduction Intervention for Disordered Eating Behaviours
Scientific title
Evaluation of a smartphone-based stress reduction intervention for reducing episodes of disordered eating among women who engage in stress-related eating behaviours.
Secondary ID [1] 297582 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Disordered Eating 311837 0
Binge Eating 311838 0
Condition category
Condition code
Mental Health 310437 310437 0 0
Eating disorders

Study type
Description of intervention(s) / exposure
Brief name: Stress reduction intervention.

The intervention will involve a series of brief 3-5 minute stress reduction activities that are delivered via a smartphone application ('app'). These activities are audio files which included guided meditations, breathing exercises, thought defusion (letting go of thoughts), body scans, and gratitude exercises.

There will be two intervention groups: guided and self-guided. Once access to the app is provided, participants in both groups will be able to access the stress-reduction activities whenever they choose. However, it is recommended that participants use these activities at times when they are feeling stressed. Participants in the guided intervention group will also receive personalised prompts to remind them to use the app; these are delivered when participants report they are at least moderately stressed. This reporting occurs via periodic surveys prompted through the same app; these are delivered 4 times per day at randomised times between the hours of 9am to 9pm for the four week duration of the study. The survey comprises only one question ("How stressed are you right now?"). Participants in the self-guided intervention group will also complete this monitoring and have access to the stress-reduction activities to use whenever they choose, however they will not receive any personalised reminders.

The intervention phase of the study will last for four weeks.

Participants' use of the intervention will be monitored through the app, in which participants will be asked to respond to a brief one-item survey prior to and after using a stress-reduction activity. As the activities are delivered via the app, it is not possible to directly assess fidelity. Adherence will be promoted through provision of a variety of different exercises to allow participants to engage with those they find most helpful and reduce the likelihood of disinterest due to repetition.
Intervention code [1] 313813 0
Treatment: Other
Intervention code [2] 313814 0
Intervention code [3] 313815 0
Comparator / control treatment
This study will employ an active/wait-list control group. Participants in the control group will be asked to monitor their mood and eating behaviours via a smartphone app. The app will prompt participants to complete four surveys per day for four weeks. Participants will be prompted to complete these surveys at randomised times between the hours of 9am and 9pm. The surveys are estimated to take less than 1 minute to complete and will ask 5 questions about participants' current mood (e.g., “How stressed do you feel right now?”) and eating behaviours (e.g., “Since the last survey, have you eaten, or had an urge to eat, as a way to cope with, distract from, or soothe distressing feelings?”).

After the four week monitoring period, participants in the control group will receive access to the stress reduction intervention.
Control group

Primary outcome [1] 319306 0
Frequency of disordered eating episodes (i.e., binge eating, overeating, and loss of control eating) as measured by self-report using the Eating Disorder Examination Questionnaire.
Timepoint [1] 319306 0
Baseline; Immediately post-intervention (primary endpoint); 4-week follow up
Primary outcome [2] 319307 0
Change in negative affect as measured by the Positive and Negative Affect Schedule
Timepoint [2] 319307 0
Baseline; Immediately post-intervention (primary endpoint); 4-week follow up
Secondary outcome [1] 367664 0
Change in Eating Disorder Examination Questionnaire Total Score
Timepoint [1] 367664 0
Baseline; Immediately post-intervention (primary endpoint); 4-week follow up

Key inclusion criteria
Identify as a woman, aged 18 years and over, own a smartphone, engage in stress-related eating behaviours, this may include eating mindlessly, non-hungry eating, eating foods one may normally choose to avoid, overeating, feeling a sense of loss of control over one’s eating, and binge eating.
Minimum age
18 Years
Maximum age
No limit
Can healthy volunteers participate?
Key exclusion criteria

Study design
Purpose of the study
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)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
The required sample size is 183 (61 in each group). This has been calculated to allow for detection of a standardised group difference post-intervention between intervention and control groups of 0.5, at a power level of .8 and an alpha of .05, with allowance for 20% attrition.

The primary analysis will be multilevel models, with maximum likelihood estimation to account for missing data due to attrition. Further, subsequent exploratory analyses will be conducted to identify patterns of intervention use and whether accumulated use of the intervention has beneficial effects on stress and/or disordered eating episodes beyond that seen for each individual use.

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 302129 0
Name [1] 302129 0
Deakin University
Address [1] 302129 0
School of Psychology, Faculty of Health.
221 Burwood Highway,
Burwood, Victoria 3125
Country [1] 302129 0
Primary sponsor type
A/Prof Matthew Fuller-Tyszkiewicz
School of Psychology, Deakin University
221 Burwood Highway
Burwood, Victoria 3125
Secondary sponsor category [1] 301966 0
Name [1] 301966 0
Mrs Jodie Mechielsen
Address [1] 301966 0
School of Psychology, Deakin University
221 Burwood Highway
Burwood, Victoria 3125
Country [1] 301966 0
Other collaborator category [1] 280581 0
Name [1] 280581 0
A/Prof Alexander Mussap
Address [1] 280581 0
School of Psychology, Deakin University
221 Burwood Highway
Burwood, Victoria 3125
Country [1] 280581 0

Ethics approval
Ethics application status
Ethics committee name [1] 302812 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 302812 0
Deakin Research Integrity
221 Burwood Highway
Burwood, Victoria 3125
Ethics committee country [1] 302812 0
Date submitted for ethics approval [1] 302812 0
Approval date [1] 302812 0
Ethics approval number [1] 302812 0

Brief summary
The proposed study aims to evaluate the efficacy of a stress-reduction intervention for unhealthy and disordered eating behaviours. The study will be conducted as a randomised control trial, with a wait-list control group and two intervention groups; one intervention group will be prompted to use the intervention, whilst the other will not. All groups will complete a baseline survey, followed by four weeks of ecological momentary assessment to obtain data regarding their eating behaviours and affect. During this time, the intervention groups will also be provided with brief stress-reduction activities via smartphone application that they can complete when stressed. Participants in the intervention groups will also complete a four-week follow-up survey. The study will recruit at least 183 women, aged 18 years and over, who report stress-related unhealthy or disordered eating. It is expected that use of the intervention will reduce the momentary and longer-term risk of disordered eating.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 91478 0
A/Prof Matthew Fuller-Tyszkiewicz
Address 91478 0
School of Psychology, Deakin University
221 Burwood Highway
Burwood, Victoria 3125
Country 91478 0
Phone 91478 0
Fax 91478 0
Email 91478 0
Contact person for public queries
Name 91479 0
A/Prof Matthew Fuller-Tyszkiewicz
Address 91479 0
School of Psychology, Deakin University
221 Burwood Highway
Burwood, Victoria 3125
Country 91479 0
Phone 91479 0
Fax 91479 0
Email 91479 0
Contact person for scientific queries
Name 91480 0
A/Prof Matthew Fuller-Tyszkiewicz
Address 91480 0
School of Psychology, Deakin University
221 Burwood Highway
Burwood, Victoria 3125
Country 91480 0
Phone 91480 0
Fax 91480 0
Email 91480 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
Protection of participant confidentiality.
What supporting documents are/will be available?
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 7108 0
Informed consent form
Citation [1] 7108 0
Link [1] 7108 0
Email [1] 7108 0
Other [1] 7108 0
Attachment [1] 7108 0
Type [2] 7109 0
Ethical approval
Citation [2] 7109 0
Link [2] 7109 0
Email [2] 7109 0
Other [2] 7109 0
Attachment [2] 7109 0
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary