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Trial registered on ANZCTR


Registration number
ACTRN12619000639123
Ethics application status
Approved
Date submitted
24/04/2019
Date registered
30/04/2019
Date last updated
15/07/2022
Date data sharing statement initially provided
30/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
CompassionateUs: A randomised evaluation trial of an interactive compassionate-based digital health program on psychological wellbeing.
Scientific title
A randomised evaluation trial of an interactive compassionate-based digital health program (CompassionateUs), offered through My Digital Health, for increasing psychological wellbeing in adults.
Secondary ID [1] 298050 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological wellbeing 312527 0
Self-compassion 312528 0
Anxiety symptoms 312531 0
Depressive symptoms 312532 0
Psychological distress symptoms 312536 0
Condition category
Condition code
Mental Health 311062 311062 0 0
Anxiety
Mental Health 311063 311063 0 0
Depression
Mental Health 311104 311104 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A compassion-based digital health program (called CompassionateUs), for adults in the general community, will be evaluated. CompassionateUs will be offered through the My Digital Health platform. People consenting to take part in the study will be randomly allocation to one of three conditions upon completion of the pre-program survey. The three conditions vary based on when program modules are released (i.e., all modules are open from first login; modules are released on a time schedule [scheduled every 4 days for the first five modules and then every 7 days for the final five modules]; modules released sequentially, following completion of the current module).

The CompassionateUs program consists of 10 brief modules (i.e., 5 compassion-knowledge building and 5 compassion-skill building), delivered over 8 weeks, all designed to assist adults in the general population develop greater compassion for themselves and others and improve general wellbeing. Each module will take 10-20 minutes to read and include text, graphics, audio, video, editable forms, interactive elements (e.g., hotspots), self-check module quizzes and downloads, designed specifically for this study. To consolidate learning, participants will be asked to complete various practise activities (10 minutes per day on average). Participants will also receive automated emails (e.g., when a module is released, once they have completed a module, when scheduled program assessments are due). Modules are accessible via web, mobile or tablet devices.

The CompassionateUs 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. It also includes a ‘Connect to Practitioner’ request button. If clicked, an Australian-based participant can request that we add their healthcare practitioner to their My Digital Health account. If the healthcare practitioner consents to participate, the healthcare practitioner is then digitally connected to the participant’s My Digital Health account. Here, each healthcare practitioner receives automatic access to the digital health program itself, the communication system and a brief healthcare practitioner digital mental health training program. Providing the participant consents, the healthcare provider can also view the participant’s progress graphs, account activity and self-monitoring data. After the digital connection has been made, it is then up to the healthcare practitioner to decide how best to utilise these features and tools.

Participants will complete a pre-program survey assessment (Week 0), during program survey (Week 3 & 6), a post-program survey (Week 9) and a 3-month follow-up survey (Week 21) and they will be able to access the CompassionateUs program for the entire trial period. However, while the ‘during’, post-intervention and follow up assessments are scheduled, participants will not be able to access the program until they have completed the scheduled assessments (or after the expiry time to complete the scheduled assessment has lapsed). A random selection of participants might also be invited to participate in a brief post-program interview by telephone, instant messaging or video-chat. The interview will ask them about their experiences of using the CompassionateUs program.

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 daily mood and lifestyle event survey data and the scheduled intervention assessments. Participating healthcare practitioners may also be invited to provide feedback about their digital connection experience.
Intervention code [1] 314280 0
Prevention
Intervention code [2] 314281 0
Behaviour
Intervention code [3] 314282 0
Treatment: Other
Comparator / control treatment
Participants in all 3 conditions will be asked to complete the same questionnaires and be provided with the exact same content. However, one condition will be able to access all of the program content from their first log in (comparator arm), the second will be able to access each next sequential module the moment they have completed the current module (i..e., stage release) and the third condition, will be provided with a 'scheduled release' of the program modules. That is, a new module will be made available to them based on a timeline schedule.
Control group
Active

Outcomes
Primary outcome [1] 319843 0
Self-compassion levels using the SCS
Timepoint [1] 319843 0
Pre-intervention (Week 0), during intervention (Week 3 and 6), post (Week 9 - primary endpoint) and 3 month follow-up (Week 21)
Primary outcome [2] 319844 0
Mental wellness using the MHC-SF
Timepoint [2] 319844 0
Pre-intervention (Week 0), during intervention (Week 3 and 6), post (Week 9 - primary endpoint) and 3 month follow-up (Week 21)
Secondary outcome [1] 369668 0
Anxiety symptoms using the GAD-7
Timepoint [1] 369668 0
Pre-intervention (Week 0), post-intervention (Week 9) and 3 month follow-up (Week 21)
Secondary outcome [2] 369669 0
Depressive symptoms using the PHQ-9
Timepoint [2] 369669 0
Pre-intervention (Week 0), post-intervention (Week 9) and 3 month follow-up (Week 21)
Secondary outcome [3] 369670 0
General psychological distress levels using the K10
Timepoint [3] 369670 0
Pre-intervention (Week 0), post-intervention (Week 9) and 3 month follow-up (Week 21)
Secondary outcome [4] 369671 0
Optimism using the LOT-R
Timepoint [4] 369671 0
Pre-intervention (Week 0), post-intervention (Week 9) and 3 month follow-up (Week 21)
Secondary outcome [5] 369672 0
Emotional regulation using the DERS - B
Timepoint [5] 369672 0
Pre-intervention (Week 0), post-intervention (Week 9) and 3 month follow-up (Week 21)
Secondary outcome [6] 369673 0
Hope using the Adult Hope Scale
Timepoint [6] 369673 0
Pre-intervention (Week 0), post-intervention (Week 9) and 3 month follow-up (Week 21)
Secondary outcome [7] 369674 0
Self criticism level using the FSCRS
Timepoint [7] 369674 0
Pre-intervention (Week 0), during intervention (Week 6), post-intervention (Week 9) and 3 month follow-up (Week 21)
Secondary outcome [8] 369675 0
Social Connectedness using the SC&SAS
Timepoint [8] 369675 0
Pre-intervention (Week 0), post-intervention (Week 9) and 3 month follow-up (Week 21)
Secondary outcome [9] 369676 0
Program usability using the SUS
Timepoint [9] 369676 0
During intervention (Week 3)
Secondary outcome [10] 369677 0
Personality traits using the TIPI
Timepoint [10] 369677 0
Pre intervention (Week 0)
Secondary outcome [11] 369678 0
Intervention satisfaction will be measured using the TSQ (self-developed survey)
Timepoint [11] 369678 0
Post intervention (Week 9)
Secondary outcome [12] 369679 0
Alcohol and drug use levels (self-developed questions)
Timepoint [12] 369679 0
Pre-intervention (Week 0), post-intervention (Week 9) and 3 month follow-up (Week 21)
Secondary outcome [13] 369680 0
Chronic physical illness diagnosis questions (self developed questions)
Timepoint [13] 369680 0
Pre-intervention (Week 0)
Secondary outcome [14] 369681 0
Current use of prescribed medication(s) question and followed up with medication type (self-developed questions)
Timepoint [14] 369681 0
Pre-intervention (Week 0), post-intervention (Week 9) and 3 month follow-up (Week 21)
Secondary outcome [15] 369682 0
Physical activity levels using single item questions (self developed questions)
Timepoint [15] 369682 0
Pre-intervention (Week 0), post-intervention (Week 9) and 3 month follow-up (Week 21)
Secondary outcome [16] 369683 0
Use of services for a physical and mental health conditions questions (self developed questions)
Timepoint [16] 369683 0
Pre-intervention (Week 0), post-intervention (Week 9) and 3 month follow-up (Week 21)
Secondary outcome [17] 369684 0
Mental health, physical health and quality of life question - 6 point rating scale (self developed questions)
Timepoint [17] 369684 0
Pre-intervention (Week 0), post-intervention (Week 9) and 3 month follow-up (Week 21)
Secondary outcome [18] 369685 0
Sleep quantity question (self-developed question).
Timepoint [18] 369685 0
Pre-intervention (Week 0), post-intervention (Week 9) and 3 month follow-up (Week 21)
Secondary outcome [19] 369777 0
CAGE-AID is used if questions about alcohol or substance use (see secondary outcome 12 above) indicates problematic use.
Timepoint [19] 369777 0
Pre-intervention (Week 0), post-intervention (Week 9) and 3 month follow-up (Week 21)

Eligibility
Key inclusion criteria
Must be 18 years of age or over.
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
Prevention
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 CompassionateUs 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 CompassionateUs 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-, during, post- and follow-up variables will be subjected to mixed methods and repeated measures analyses to determine significant changes over group and time. The primary outcome measure is the SCS. Assuming a conservative small to medium effect (i.e. GPower f(v) test = 0.20), significance set at 5% (p = .05), power at 80%, a total sample of 174 will be required to demonstrate statistical significance on the primary outcome measure. However, allowing for a 50% attrition rate, we will be required to recruit a total sample of 348 participants.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Other reasons/comments
Other reasons
We have closed this trial as we are retiring the My Digital Health platform and shifting to a new upgraded platform. However we also found it difficult to recruit partipants for this program.
Date of first participant enrolment
Anticipated
3/05/2019
Actual
9/07/2019
Date of last participant enrolment
Anticipated
31/12/2022
Actual
9/07/2021
Date of last data collection
Anticipated
15/06/2023
Actual
24/12/2021
Sample size
Target
348
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 21429 0
New Zealand
State/province [1] 21429 0
Country [2] 21430 0
Canada
State/province [2] 21430 0
Country [3] 21431 0
United States of America
State/province [3] 21431 0

Funding & Sponsors
Funding source category [1] 302578 0
University
Name [1] 302578 0
Federation University
Country [1] 302578 0
Australia
Primary sponsor type
University
Name
Federation University
Address
University Drive, Mt Helen Campus, Victoria, 3350
Country
Australia
Secondary sponsor category [1] 302488 0
None
Name [1] 302488 0
Address [1] 302488 0
Country [1] 302488 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303220 0
Federation University Human Research Ethics Committee
Ethics committee address [1] 303220 0
Federation University Australia. Office 218, Building F, Mt Helen Campus. PO Box 663, Ballarat VIC 3353
Ethics committee country [1] 303220 0
Australia
Date submitted for ethics approval [1] 303220 0
20/01/2019
Approval date [1] 303220 0
01/03/2019
Ethics approval number [1] 303220 0
A19-003

Summary
Brief summary
A compassion-based digital health program (called CompassionateUs) to increase psychological wellbeing, for adults in the general community, will be evaluated. CompassionateUs is one of the digital health programs offered through the My Digital Health platform. People who consent to take part in the study will be randomly allocation to one of three conditions upon completion of the pre-program survey. The three conditions vary based on when program modules are released (i.e., all modules are open from first login; modules are released on a time schedule; modules released sequentially, following completion of the current module).

The CompassionateUs program consists of 10 brief modules (i.e., 5 compassion-knowledge building and 5 compassion-skill building), delivered over 8 weeks. Each module will take 10-20 minutes to read and to consolidate learning, participants will be asked to complete various practise activities (10 minutes per day on average). Participants will also receive automated emails (e.g., when a module is released, once they have completed a module, when scheduled program assessments are due).

It is expected that people who undertake the CompassionateUs program will show improvements in their psychological wellbeing (e.g., self-compassion levels) at post-intervention and follow-up assessment time points.
Trial website
https://compassion.mydigitalhealth.org.au
Trial related presentations / publications
Public notes
CompassionateUs is globally accessible via the web.

Contacts
Principal investigator
Name 92898 0
Prof Britt Klein
Address 92898 0
Federation University. 107 Lydiard Street South, Ballarat Central VIC 3350
Country 92898 0
Australia
Phone 92898 0
+61 35327 6717
Fax 92898 0
Email 92898 0
[email protected]
Contact person for public queries
Name 92899 0
Britt Klein
Address 92899 0
Federation University. 107 Lydiard Street South, Ballarat Central VIC 3350
Country 92899 0
Australia
Phone 92899 0
+61 35327 6717
Fax 92899 0
Email 92899 0
[email protected]
Contact person for scientific queries
Name 92900 0
Britt Klein
Address 92900 0
Federation University. 107 Lydiard Street South, Ballarat Central VIC 3350
Country 92900 0
Australia
Phone 92900 0
+61 35327 6717
Fax 92900 0
Email 92900 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?
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 for any purpose, 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1932Informed consent form    https://compassion.mydigitalhealth.org.au/privacy-... [More Details]
1952Informed consent form    https://compassion.mydigitalhealth.org.au/plis-hcp... [More Details]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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