Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000129886
Ethics application status
Approved
Date submitted
8/01/2021
Date registered
8/02/2021
Date last updated
8/02/2021
Date data sharing statement initially provided
8/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of the effects of the iMindTime Digital Health program on wellbeing
Scientific title
A prospective, randomised controlled trial to evaluate the effects of the iMindTime Digital Health program on anxiety and depression in adults
Secondary ID [1] 303124 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 320226 0
Anxiety 320227 0
Condition category
Condition code
Mental Health 318160 318160 0 0
Anxiety
Mental Health 318161 318161 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: iMindTime
Description: iMindTime Digital Health program is designed to encourage an individual to be more mindful and increase their awareness of moment-to-moment experiences by being non-judgmental of their experiences and accepting what is happening in the present without wanting it to change it. iMindTime will be offered through the My Digital Health platform.The program consists of six brief modules completed over three weeks.
The modules include:
1. Mindfulness of Breath
2. Mindfulness of Emotions
3. Mindfulness of Bodily Sensations
4. Mindfulness of Sounds
5. Mindfulness of Thoughts
6. Loving Kindness Meditation

Each module comprises educational and practical material about mindfulness principles (5-10 minutes of reading time per module). To consolidate learning, participants are asked to practice the specific mindfulness principles (10-20 minutes x 3 days per module) before moving to the next module. Participants will also receive automated emails (e.g., to remind them to log on, when to complete follow-up intervention questionnaires). Modules include text, graphics, audio, and downloads. Modules can be accessible via web, mobile or tablet devices. Participant engagement with the program will be obtained through by passive analytic data (e.g., what pages they visited and when), as well as reviewing the completion of the scheduled intervention assessments.
Intervention code [1] 319423 0
Treatment: Other
Intervention code [2] 319610 0
Behaviour
Comparator / control treatment
The control group will be on a waitlist and offered access to the intervention after the 3 week intervention period.
Control group
Active

Outcomes
Primary outcome [1] 326147 0
Anxiety symptoms indexed using the Generalised Anxiety Disorder Scale
Timepoint [1] 326147 0
Baseline and post-intervention (3 weeks post-intervention commencement)
Primary outcome [2] 326148 0
Depression symptoms indexed using the Patient Health Questionnaire 9
Timepoint [2] 326148 0
Baseline and post-intervention (3 weeks post-intervention commencement)
Secondary outcome [1] 390247 0
Stress symptoms indexed using the Perceived Stress Scale
Timepoint [1] 390247 0
Baseline and post-intervention (3 weeks post-intervention commencement)
Secondary outcome [2] 391184 0
State mindfulness indexed using the Mindful Attention Awareness Scale
Timepoint [2] 391184 0
Baseline and post-intervention (3 weeks post-intervention commencement)
Secondary outcome [3] 391185 0
Trait mindfulness indexed using the The Freiburg Mindfulness Inventory
Timepoint [3] 391185 0
Baseline and post-intervention (3 weeks post-intervention commencement)

Eligibility
Key inclusion criteria
Adults (+18 years) competent to give consent and fluent in English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No internet access, does not create a My Digital Health account (requires the provision of a valid email address), does not provide consent to study conditions.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
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
Mixed-Model ANOVA will be used to evaluate the effects of the treatment over time in comparison to that of the control. Covariates may be included to adjust for confounding factors.

With 80% power to detect a small effect (.20) and alpha set at .05, we will require a minimum sample of 277 to achieve statistical significance on the primary outcomes. However, allowing for attrition, we will aim to recruit 350 participants.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/02/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
350
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 23362 0
New Zealand
State/province [1] 23362 0
Country [2] 23363 0
Canada
State/province [2] 23363 0
Country [3] 23364 0
India
State/province [3] 23364 0
Country [4] 23365 0
United Kingdom
State/province [4] 23365 0
Country [5] 23366 0
United States of America
State/province [5] 23366 0

Funding & Sponsors
Funding source category [1] 307532 0
University
Name [1] 307532 0
Federation University Australia
Country [1] 307532 0
Australia
Primary sponsor type
University
Name
Federation University Australia
Address
University Drive, Mt Helen Campus, Victoria, 3350
Country
Australia
Secondary sponsor category [1] 308210 0
None
Name [1] 308210 0
Address [1] 308210 0
Country [1] 308210 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307597 0
Federation University Human Research Ethics Committee
Ethics committee address [1] 307597 0
Ethics committee country [1] 307597 0
Australia
Date submitted for ethics approval [1] 307597 0
25/11/2020
Approval date [1] 307597 0
04/12/2020
Ethics approval number [1] 307597 0
A20-156

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

Contacts
Principal investigator
Name 107810 0
Dr Samia Toukhsati
Address 107810 0
Federation University Australia
100 Clyde Road, Berwick, VIC 3806
Country 107810 0
Australia
Phone 107810 0
+61 3 51226009
Fax 107810 0
Email 107810 0
[email protected]
Contact person for public queries
Name 107811 0
Samia Toukhsati
Address 107811 0
Federation University Australia
100 Clyde Road, Berwick, VIC 3806
Country 107811 0
Australia
Phone 107811 0
+61 3 51226009
Fax 107811 0
Email 107811 0
[email protected]
Contact person for scientific queries
Name 107812 0
Samia Toukhsati
Address 107812 0
Federation University Australia
100 Clyde Road, Berwick, VIC 3806
Country 107812 0
Australia
Phone 107812 0
+61 3 51226009
Fax 107812 0
Email 107812 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Primary and secondary outcome data
When will data be available (start and end dates)?
Available from completion of trial with no end date determined
Available to whom?
At the discretion of the Principal Investigator
Available for what types of analyses?
At the discretion of the Principal Investigator
How or where can data be obtained?
Access subject to approval by Principal Investigator (email: [email protected]), followed by a request to, and approval by, Ethics Review Committee.


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.