Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001240730
Ethics application status
Approved
Date submitted
20/06/2022
Date registered
14/09/2022
Date last updated
21/01/2024
Date data sharing statement initially provided
14/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A 4-Week Digital Mindfulness-Based Program to Support Well-being
Scientific title
A Digital Mindfulness-Based Program Delivered by a Social Robot to Investigate its Impact on Mindfulness Practice Rates and Mood in Healthy Adults
Secondary ID [1] 307233 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mindfulness 326484 0
Mood 326486 0
Condition category
Condition code
Mental Health 323753 323753 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project is designed to investigate the impact and efficacy of the new digital method (i.e a commercially available social humanoid robot with a tablet interface) to deliver a mindfulness-based program over a 4-week period using a two-group (immediate vs wait-list) trial design. This program has been adapted from a mindfulness-based program that is offered at Monash University. It is intended that this trial will explore how a social humanoid robot can help people to learn and practice mindfulness and its impact on state and trait well-being, including finding a new and interactive ways to engage people in practice that can be used in conjunction with other services, if effective.

Participants will complete a 45-minute in-person session conducted at Monash University. This session will include a 30-minute session for a Pepper robot leading the session content and training to deliver a robot-adapted version of a mindfulness-based program. Each participant will complete the session on their own, working with the robot to complete the content. At the end of the session, participants will be invited to complete a 15-minute interview with a research team member about the experience with the robot program.

Participants will receive a weekly email after the first session until the end of the 4-week program that involves additional program content that is expected to take 5 minutes to complete, such as a mindfulness meditation audio file and suggestion for informal practice. Participants are also given the option to receive a mid-week reminder. Participants will be asked to complete 2 x 20-minute online questionnaires at two and four weeks.
Intervention code [1] 323677 0
Behaviour
Intervention code [2] 323678 0
Treatment: Other
Comparator / control treatment
Participants can be randomised into the 2-week delay version of the program, which involves starting the first robot session 2 weeks after entry into the program.
Control group
Active

Outcomes
Primary outcome [1] 331511 0
A primary outcome is to determine the impact of the program on mindfulness practice in the last week using a new study-specific self-report questionnaire.
Timepoint [1] 331511 0
Baseline, Week 2, Week 4- Immediate
Baseline, Week 2, Week 4 - Delayed
Secondary outcome [1] 410129 0
A secondary outcome is to determine the impact of the program on mindfulness experience in the last two weeks - Five Facet Mindfulness Questionnaire (FFMQ)
Timepoint [1] 410129 0
Baseline, Week 2, Week 4- Immediate
Baseline, Week 2, Week 4 - Delayed
Secondary outcome [2] 410130 0
A secondary outcome is to determine the impact of the program on irritability over the last two weeks - Brief Irritability Test (BITe)
Timepoint [2] 410130 0
Baseline, Week 2, Week 4- Immediate
Baseline, Week 2, Week 4 - Delayed
Secondary outcome [3] 410131 0
A secondary outcome is to determine the impact of the program on mood over the last week - Depression, Anxiety and Stress Scale (DASS21)
Timepoint [3] 410131 0
Baseline, Week 2, Week 4- Immediate
Baseline, Week 2, Week 4 - Delayed
Secondary outcome [4] 410132 0
A secondary outcome is to determine the impact of the program on wellbeing over the last two weeks - WHO (Five) Well-Being Index
Timepoint [4] 410132 0
Baseline, Week 2, Week 4- Immediate
Baseline, Week 2, Week 4 - Delayed

Eligibility
Key inclusion criteria
At least 18 years of age or older.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they are not at least 18 years of age or older and able to provide consent

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/10/2022
Actual
31/10/2022
Date of last participant enrolment
Anticipated
30/06/2023
Actual
29/10/2023
Date of last data collection
Anticipated
31/08/2023
Actual
18/12/2023
Sample size
Target
70
Accrual to date
Final
76
Recruitment in Australia
Recruitment state(s)
QLD,VIC

Funding & Sponsors
Funding source category [1] 311536 0
University
Name [1] 311536 0
Monash University
Country [1] 311536 0
Australia
Primary sponsor type
University
Name
Monash University
Address
18 Alliance Lane and 18 Innovation Walk, Clayton Campus, VIC 3800, Australia
Country
Australia
Secondary sponsor category [1] 312947 0
None
Name [1] 312947 0
Address [1] 312947 0
Country [1] 312947 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310990 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 310990 0
Ethics committee country [1] 310990 0
Australia
Date submitted for ethics approval [1] 310990 0
07/07/2020
Approval date [1] 310990 0
24/08/2020
Ethics approval number [1] 310990 0

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

Contacts
Principal investigator
Name 119610 0
Dr Nicole Robinson
Address 119610 0
18 Alliance Lane and 18 Innovation Walk, Monash University Clayton Campus, VIC 3800, Australia
Country 119610 0
Australia
Phone 119610 0
+61 3 9905 5481
Fax 119610 0
Email 119610 0
[email protected]
Contact person for public queries
Name 119611 0
Nicole Robinson
Address 119611 0
18 Alliance Lane and 18 Innovation Walk, Monash University Clayton Campus, VIC 3800, Australia
Country 119611 0
Australia
Phone 119611 0
+61 3 9905 5481
Fax 119611 0
Email 119611 0
[email protected]
Contact person for scientific queries
Name 119612 0
Nicole Robinson
Address 119612 0
18 Alliance Lane and 18 Innovation Walk, Monash University Clayton Campus, VIC 3800, Australia
Country 119612 0
Australia
Phone 119612 0
+61 3 9905 5481
Fax 119612 0
Email 119612 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
No additional documents have been identified.