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Trial registered on ANZCTR


Registration number
ACTRN12617000573358
Ethics application status
Approved
Date submitted
7/04/2017
Date registered
24/04/2017
Date last updated
21/01/2019
Date data sharing statement initially provided
21/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of iMindTime digital health: A comprehensive mindfulness and loving kindness meditation wellbeing digital health program.
Scientific title
A randomised controlled trial of iMindTime digital health program, offer through My Digital Health, will evaluate the effectiveness of a comprehensive mindfulness and loving kindness meditation welbeing digital health program on decreasing stress, anxiety and depressive symptom levels and increase mental wellbeing in adults.
Secondary ID [1] 291140 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
Ethics approval was obtained via two amendment requests (one approved on the 27/07/2016 and a subsequent one approved on the 07/02/2017) based on the originally approved A15-115 application (ACTRN12615000820505).

Health condition
Health condition(s) or problem(s) studied:
Stress 301983 0
Mental Wellbeing 301984 0
Anxiety 301985 0
Depressive symptoms 301986 0
Condition category
Condition code
Public Health 301628 301628 0 0
Health promotion/education
Mental Health 301629 301629 0 0
Anxiety
Mental Health 302375 302375 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised controlled trial will be used to investigate the effectiveness of the iMindTime digital health program, offered through My Digital Health (parent platform). People taking part in the study will be randomly allocated to either an immediate access to the program, or delayed access (7-week delay).

The iMindTime digital health program consists of six brief sessions delivered over 3 weeks, designed to make an individual more mindful or increase awareness of moment-to-moment experiences (e.g., thoughts, feelings, sensations) and simply accept what is there without wanting it to change in any way. Participants will be asked to spend three days on each session before moving onto the next session. Each session will take 5-10 minutes to read and its user friendly and interactive components are designed to keep the user engaged. To consolidate learning, participants will be given activities (10-20 minutes per day) to complete offline to practise the principles of specific mindfulness exercises (i.e., mindfulness of the breath, mindfulness of body sensations, mindfulness of emotions, mindfulness of sounds, mindfulness of thoughts and loving kindness meditation) and asked to provide simple feedback on this practise at the next session. Participants will also receive automated emails (e.g., remind them to log on, when to complete scheduled assessments) and will be asked several questions during the study period to monitor their progress. The iMindTime sessions include text, graphics, audio, quizzes, and downloads. iMindTime can be accessible via web, mobile or tablet devices.

The iMindTime program is housed within the participant's ‘My Digital Health’ dashboard. My Digital Health is the parent platform that houses a variety of digital health programs. Via the participant’s dashboard, they are able to access several resources. This includes: My Dashboard, My Inbox, My Daily Monitoring, My Progress Graphs, My Timeline, My Profile and My Tutorial.

Participants randomised to the iMindTime digital health (immediate access) group will complete a pre-intervention assessment (Week 0), during intervention (Week 2) assessment, post-intervention assessment (Week 4) and a 1 month follow-up assessment (Week 8). Participants randomised to the delayed access group will complete the same assessment phases and will be given access to iMindTime digital health program following the 1 month follow-up assessment (Week 8). However, the delayed access group will be asked to complete the post intervention assessment after they have completed the iMindTime digital health program (Week 11). While the during, post-intervention and follow up assessments are scheduled (and access to the program has been provided), participants will not be able to access the program until they have completed the scheduled assessments (or after the expiry time to complete the assessment has lapsed). Participants will retain access to the program until Week 20.

Participant engagement with the program will be obtained through by passive analytic data (e.g., what pages / strategies they visited and when), as well as reviewing the completion of daily mood and lifestyle events surveys and scheduled intervention assessments.

Intervention code [1] 297119 0
Prevention
Intervention code [2] 297120 0
Behaviour
Intervention code [3] 297121 0
Lifestyle
Comparator / control treatment
People allocated to the delayed access group will complete the same questionnaires as the immediate access condition, but will not have access to the iMindTime digital health program for 7 weeks. In addition, participants in the delayed access group will not have access to the daily self-monitoring survey and graph during their 7 week ‘wait’ period.
Control group
Active

Outcomes
Primary outcome [1] 301026 0
Anxiety symptoms will be measued using the DASS-21
Timepoint [1] 301026 0
Pre intervention (Week 0), during intervention (Week 2), post intervention (Week 4) and 1 month follow-up (Week 8)
Primary outcome [2] 301780 0
Depressive symptoms will be measured using the DASS-21
Timepoint [2] 301780 0
Pre intervention (Week 0), during intervention (Week 2), post intervention (Week 4) and 1 month follow-up (Week 8)
Primary outcome [3] 301781 0
Stress symptoms will be measured using the DASS-21
Timepoint [3] 301781 0
Pre intervention (Week 0), during intervention (Week 2), post intervention (Week 4) and 1 month follow-up (Week 8)
Secondary outcome [1] 331498 0
Affective styles will be measured using the ASQ
Timepoint [1] 331498 0
Pre intervention (Week 0), post intervention (Week 4) and 1 month follow-up (Week 8)
Secondary outcome [2] 331499 0
Optimism will be measured using the LOT-R
Timepoint [2] 331499 0
Pre intervention (Week 0), during intervention (Week 2), post intervention (Week 4) and 1 month follow-up (Week 8)
Secondary outcome [3] 331500 0
General psychological distress will be measured using the K10
Timepoint [3] 331500 0
Pre intervention (Week 0), post intervention (Week 4) and 1 month follow-up (Week 8)
Secondary outcome [4] 331501 0
Time perception as measured by the Time Dilation Test (self-developed)
Timepoint [4] 331501 0
Pre intervention (Week 0) and post intervention (Week 4)
Secondary outcome [5] 331502 0
Personality traits will be measured using the TIPI
Timepoint [5] 331502 0
Pre intervention
Secondary outcome [6] 331503 0
Intervention satisfaction, including engagement, will be measured using the TSQ
Timepoint [6] 331503 0
Post intervention (Week 8 - immediate start; Week 11 - delayed access)
Secondary outcome [7] 331504 0
Mental health wellbeing will be measured using the MCH-SF
Timepoint [7] 331504 0
Pre intervention (Week 0), during intervention (Week 2), post intervention (Week 4) and 1 month follow-up (Week 8)
Secondary outcome [8] 333855 0
Physical activity levels using single item questions (self developed)
Timepoint [8] 333855 0
Pre intervention (Week 0), post intervention (Week 4) and 1 month follow-up (Week 8)
Secondary outcome [9] 334095 0
Social Connectedness Rating question using a 5 point scale (self developed)
Timepoint [9] 334095 0
Pre intervention (Week 0), post intervention (Week 4) and 1 month follow-up (Week 8)
Secondary outcome [10] 334096 0
Alcohol consumption levels (self-developed questions) and followed up with CAGE-AID questions if high alcohol consumption is indicated
Timepoint [10] 334096 0
Pre intervention (Week 0), post intervention (Week 4) and 1 month follow-up (Week 8)
Secondary outcome [11] 334097 0
Drug use (self-developed questions) and followed up with CAGE-AID questions if high use of drugs is indicated.
Timepoint [11] 334097 0
Pre intervention (Week 0), post intervention (Week 4) and 1 month follow-up (Week 8)
Secondary outcome [12] 334098 0
Sleep quantity and quality questions (self-developed and 4 ISI items used).
Timepoint [12] 334098 0
Pre intervention (Week 0), post intervention (Week 4) and 1 month follow-up (Week 8)
Secondary outcome [13] 334099 0
Chronic physical illness diagnosis questions (self developed)
Timepoint [13] 334099 0
Pre intervention (Week 0)
Secondary outcome [14] 334100 0
Mental health condition diagnosis questions (self developed)
Timepoint [14] 334100 0
Pre intervention (Week 0)
Secondary outcome [15] 334101 0
Current use of prescribed medication(s) question (self-developed)
Timepoint [15] 334101 0
Pre intervention (Week 0), post intervention (Week 4) and 1 month follow-up (Week 8)
Secondary outcome [16] 334102 0
Use of services for a physical health condition questions (self developed)
Timepoint [16] 334102 0
Pre intervention (Week 0), post intervention (Week 4) and 1 month follow-up (Week 8)
Secondary outcome [17] 334103 0
Use of mental health services for a mental health condition questions (self developed)
Timepoint [17] 334103 0
Pre intervention (Week 0), post intervention (Week 4) and 1 month follow-up (Week 8)
Secondary outcome [18] 334104 0
Quality of Life Rating Question - 6 point scale (self developed)
Timepoint [18] 334104 0
Pre intervention (Week 0), post intervention (Week 4) and 1 month follow-up (Week 8)
Secondary outcome [19] 334105 0
Mental Health Rating Question - 6 point scale (self developed)
Timepoint [19] 334105 0
Pre intervention (Week 0), post intervention (Week 4) and 1 month follow-up (Week 8)
Secondary outcome [20] 334106 0
Physical Health Rating Question - 6 point scale (self developed)
Timepoint [20] 334106 0
Pre intervention (Week 0), post intervention (Week 4) and 1 month follow-up (Week 8)

Eligibility
Key inclusion criteria
Participants must be 18 years or older.
Minimum age
18 Years
Maximum age
No limit
Gender
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
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be invited to register for the study on the iMindTime child website (or via the parent website - My Digital Health) following ‘My Digital Health’ account creation. Once an account is created, they will be required to provide their informed consent after reading through the iMindTime evaluation study Plain Language Information Statement. Following informed consent, participants will then be presented with the pre-intervention assessment questionnaires. Once completed the participant will then be informed as to which condition they have been randomly allocated to (on screen and also sent an automated email). The My Digital Health platform software randomly allocates participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated block design method
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
Pre-, post- and follow-up variables will be subjected to mixed methods repeated measures to determine significant changes over time.

Previous research has reported small-medium effects can be expected. Therefore, assuming a small-medium effect (i.e., GPower f(v) test = 0.30), significance set at 5% (p = .05), power at 80%, a total sample size of 126 will be required to demonstrate statistical significance on the primary analysis. However, allowing for a 50% attrition rate, we will be required to recruit N = 189 participants.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 8808 0
New Zealand
State/province [1] 8808 0
Country [2] 8809 0
United Kingdom
State/province [2] 8809 0
Country [3] 8810 0
United States of America
State/province [3] 8810 0
Country [4] 8811 0
Canada
State/province [4] 8811 0

Funding & Sponsors
Funding source category [1] 295577 0
University
Name [1] 295577 0
Federation University
Address [1] 295577 0
University Drive, Mt Helen Campus, Victoria, 3350
Country [1] 295577 0
Australia
Primary sponsor type
University
Name
Federation University
Address
University Drive, Mt Helen Campus, Victoria, 3350
Country
Australia
Secondary sponsor category [1] 294408 0
None
Name [1] 294408 0
Address [1] 294408 0
Country [1] 294408 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296899 0
Federation University Higher Research Ethics Committee
Ethics committee address [1] 296899 0
Federation University. Office 218, Building F, Mt Helen Campus. PO Box 663, Ballarat, 3353
Ethics committee country [1] 296899 0
Australia
Date submitted for ethics approval [1] 296899 0
03/02/2017
Approval date [1] 296899 0
07/02/2017
Ethics approval number [1] 296899 0
A15-115

Summary
Brief summary
A randomised controlled trial will be used to investigate the effectiveness of the iMindTime program. The iMindTime program will be offered through the My Digital Health platform.

People visiting the website, in response to advertisements or through self-interest, will be informed of the availability of the iMindTime program and invited to participate in the study. People who consent to take part in the study will be randomly allocated to either an immediate access to the program, or delayed access (7-week delay).

The iMindTime digital health program consists of six brief sessions, over 3 weeks, designed to make an individual more mindful or increase awareness of moment-to-moment experiences (e.g., thoughts, feelings, sensations) and simply accepting what is there without wanting it to change in any way. Participants will spend three days on each session before moving onto the next session. Each session will require 5-10 minutes to read and its user friendly and interactive components are designed to keep the user engaged. To consolidate learning, participants will be given activities (10-20 minutes per day) to complete offline to practise the principles of specific mindfulness exercises (i.e., mindfulness of the breath, mindfulness of body sensations, mindfulness of emotions, mindfulness of sounds, mindfulness of thoughts and loving kindness meditation) and asked to provide simple feedback on this practise at the next session. Participants will also receive automated emails (e.g., remind them to log on, when to complete questionnaires) and will be asked to self-monitor their mood and lifestyle events.

Participants randomised to the iMindTime digital health (immediate access) group will complete a pre-intervention assessment (Week 0), during intervention (Week 2) assessment, post-intervention assessment (Week 4) and a 1 month follow-up assessment (Week 8). Participants randomised to the delayed access group will complete the same assessment phases and will be given access to iMindTime digital health program following the 1 month follow-up assessment (Week 8). However, the delayed access group will be asked to complete the post intervention assessment after they have completed the iMindeHealth program (Week 11).

It is expected that people who undertake iMindTime immediately will show greater reductions in negative affect and increases in mental wellbeing at post and 1 month follow-up time points, relative to the delayed access group.
Trial website
https://imindtime2.mydigitalhealth.org.au/ (direct, child site)
https://www.mydigitalhealth.org.au (parent site)
Trial related presentations / publications
Public notes
iMindTime is globally accessible via the web.

Contacts
Principal investigator
Name 72366 0
Prof Britt Klein
Address 72366 0
Federation University
University Drive, Mt Helen Campus, 3350, Victoria
Country 72366 0
Australia
Phone 72366 0
+61 3 5327 6717
Fax 72366 0
Email 72366 0
b.klein@federation.edu.au
Contact person for public queries
Name 72367 0
Prof Britt Klein
Address 72367 0
Federation University
University Drive, Mt Helen Campus, 3350, Victoria
Country 72367 0
Australia
Phone 72367 0
+61 3 5327 6717
Fax 72367 0
Email 72367 0
b.klein@federation.edu.au
Contact person for scientific queries
Name 72368 0
Prof Britt Klein
Address 72368 0
Federation University
University Drive, Mt Helen Campus, 3350, Victoria
Country 72368 0
Australia
Phone 72368 0
+61 3 5327 6717
Fax 72368 0
Email 72368 0
b.klein@federation.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Relevant individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
No start or end date as yet determined.
Available to whom?
Case-by-case basis at the discretion of Principal Investigator.
Available for what types of analyses?
Case-by-case basis at the discretion of Principal Investigator.
How or where can data be obtained?
Access subject to approval by Principal Investigator, followed by submission to the Ethical Review Committee to access the de-identified data and approval granted.
What supporting documents are/will be available?
Informed consent form
How or where can supporting documents be obtained?
Type [1] 1086 0
Informed consent form
Citation [1] 1086 0
Link [1] 1086 0
Email [1] 1086 0
Other [1] 1086 0
https://imindtime2.mydigitalhealth.org.au/plain-language-information-statement/
Attachment [1] 1086 0
Summary results
No Results