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Trial registered on ANZCTR


Registration number
ACTRN12619001009101
Ethics application status
Approved
Date submitted
1/07/2019
Date registered
15/07/2019
Date last updated
15/07/2019
Date data sharing statement initially provided
15/07/2019
Date results information initially provided
15/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Human Touch: The Influence of Human Support on Adherence to, and Outcomes of, an Online, Lifestyle-based Mental Health Intervention
Scientific title
A Web- and Mobile-app-based Mental Health Promotion Intervention Comparing Email, SMS and Videoconferencing Support on the Mental Wellbeing of a Healthy Cohort: A Randomized Comparative Study
Secondary ID [1] 298635 0
None
Universal Trial Number (UTN)
U1111-1236-2358
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health 313511 0
Condition category
Condition code
Mental Health 311941 311941 0 0
Depression
Public Health 311942 311942 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is a comparative randomised trial in which participants will be assigned to one of three Arms. All participants will undertake a 10-week online lifestyle program (detailed below) that incorporates evidence-based strategies for improving mental wellbeing from the disciplines of Lifestyle Medicine and Positive Psychology. The three Arms of the study vary only in the level of human support offered to the participants.
All participants received a weekly email on the day prior to the next session commencing. The email reminded participants that the next lesson was about to begin and invited them to click on a link and watch a 20-25 second introductory video by the presenter. Three days after a lesson was released, the system checked to see if the participant had logged any challenges, if ‘yes’, participants were sent an email validating their participation, if ‘no’, an email prompted the participant to complete the relevant challenge. Eight days after a new lesson was released, participants, who had not watched the video, were sent an email reminder.

Arm 1 - No human support, completely automated online intervention with automated emails.

Arm 2 – Same as Arm 1 plus personalised weekly text messages sent by one of the research team members (i.e. university researcher) with an education background. Each SMS was personalised by including the participants’ first name with a predetermined message to prompt engagement with the content and/or challenges. Messages included a combination of introductions to the topic to be explored, reminders to watch the presentation and/or complete challenges and motivational quotes relevant to the topic.

Arm 3 – Same as Arm 1 with weekly synchronous videoconference support group. Discussion sessions lasted 20-30 minutes and were led by one experienced online group facilitator (university researcher). Videoconferencing sessions included a recap of the weekly content by the facilitator, and a series of open-ended questions to allow participants to share what they had learned from the content, discuss challenge experiences and dialogue on ways to incorporate strategies learned into everyday life. A total of nine different sessions were made available each week (facilitated by the same facilitator). An attendance list was kept to measure participation in videoconferencing discussions.

The intervention, designed specifically for this study, is an online 10-week lifestyle program that incorporates evidence-based strategies for improving mental wellbeing from the disciplines of Lifestyle Medicine and Positive Psychology. The program is administered through an online platform and learning management system. The program will be conducted once, with all participants engaging simultaneously. Being online, the participants can access the program from their place of residence.

Each participant is granted access to the online platform and each week they are supplied with educational material (in the form of a video presentation and readings) that require a 30 minute (approximately) commitment. Participants are required to view the educational videos and data analytics measure adherence.

Participants are then encouraged to practically apply the learnings from the lesson in the form of “challenges”. Specifically, the participants are offered a daily challenge that require 5-30 minutes each day (depending upon the week, see below) and then one weekly challenge that does not have a specified time requirement. The challenges are presented as "challenge by choice" and the participants are encouraged to engage in the challenges to the extent that they are able. Engagement with the challenges is monitored by the participants logging their challenge involvement on the online platform and data analytics provide adherence information.

The topics covered in the program and the associated challenges are as follows:

1 Speak Positively (Your Limbo is Listening)
• Limbic System introduction – the “emotional brain”
• Limbic System is ‘wired’ to language area of brain.
Daily challenge: Offer a genuine compliment.
Weekly challenge: Memorise an inspirational text or saying.

2 Move Dynamically (Motion Creates Emotion)
• Proprioceptors (nerve cells that detect movement) pass through the Limbic System.
• Movement (even just 10 minutes) improves mood.
Daily challenge: Complete 30 minutes of moderate-intensity activity.
Weekly challenge: Perform resistance exercises once during week (exercises demonstrated on video).

3 Immerse in an Uplifting Natural Environment (Blue and Green Should Often be Seen)
• The Limbic System receives messages from all the senses.
• The Limbic System likes blue and green spaces (i.e. natural settings).
• The Limbic System needs about 30 minutes of 10,000 LUX of light daily.
Daily challenge: Immerse in an uplifting natural environment for 30 minutes daily.
Weekly challenge: Watch a sunrise from an appealing blue or green location.

4 Immerse in a Positive Social Environment (Together Feels Better)
• Limbic systems communicate.
• Create positive social environments by making new friends or strengthening existing relationships.
Daily challenge: Do something intentional to show a friend or family member they are loved (use their love language).
Weekly challenge: Give up your right to hurt someone who has hurt you (Act of Forgiveness).

5 Look to the Positive (Feelings Follow Your Focus)
• ‘Emotional Brain’ is wired to ‘Thinking Brain’.
• What you focus on affects how you feel.
• Upward or downward spirals.
Daily challenge: Write down three things that went well today “What Went Well?”.
Weekly challenge: Gratitude visit – identify someone you are grateful to, write a gratitude letter to them, deliver and read in person, if possible.

6 Eat Nutritiously (Food Feeds Your Mood)
• Gut bacteria linked to mood.
• Feed gut bacteria high fibre diet.
• Plant based foods are high fibre.
• Eat a wide variety of fruit, vegetables, legumes, grains.
Daily challenge: Eat eight fists full of fibre daily.
Weekly challenge: Prepare and share a high-fibre plant based meal with one or more friends.

7 Rest – Sleep (Rest to Feel Your Best)
• Sleep is fundamental for feeling upbeat (7-8 hours optimal).
• Blue light vs. yellow/orange light.
• Caffeine, lack of physical activity and blue light – deprived sleep.
Daily challenge: Spend 8 hours in bed every night.
Weekly challenge: Spend an evening by firelight.

8 Rest – from Stress (Stress Less)
• SMILERS strategies ‘open the valves’.
• Physical activity, practicing mindfulness, laughing, rest day.
Daily challenge: Fifteen minute ‘sit in silence’ mindful activity.
Weekly challenge: Take a ‘guilt-free’ day off.

9 Serve others (Giving is Living)
• Contributing/serving is emotionally uplifting.
• Serve sustainably using signature strengths.
Daily challenge: Perform one or more random acts of kindness each day.
Weekly challenge: Use your significant strength to perform a significant act of service.

10 What Does it Take to Flourish?
• Five areas to flourish: PEARM – Positive emotions, engagement, achievement, relationships, meaning.
Daily challenge: Spend time engaging in something you enjoy.
Weekly challenge: Set a goal.
Intervention code [1] 314900 0
Lifestyle
Intervention code [2] 314958 0
Behaviour
Comparator / control treatment
The control group (Arm 1) undertake a standardised version of the same lifestyle intervention as Arm 2 and Arm 3 but receive no level of personalised human support.
Control group
Active

Outcomes
Primary outcome [1] 320602 0
The 36-Item Short Form Survey (SF-36)
Timepoint [1] 320602 0
Baseline (Week 0), post-intervention (Week 12, primary endpoint), 12-weeks post-intervention (Week 24).
Primary outcome [2] 320603 0
The Depression Anxiety and Stress Scales (DASS-21)
Timepoint [2] 320603 0
Baseline (Week 0), post-intervention (Week 12, primary endpoint), 12-weeks post-intervention (Week 24).
Primary outcome [3] 320604 0
The Satisfaction With Life Scale (SWLS)
Timepoint [3] 320604 0
Baseline (Week 0), post-intervention (Week 12, primary endpoint), 12-weeks post-intervention (Week 24).
Secondary outcome [1] 372175 0
Program adherence.
Data analytics are used to record the number of sessions the participants complete (quantified by viewing the educational videos) as well as the number of "challenge points" recorded on the online platform. For the participants in Arm 3, attendance at the videoconferencing sessions is manually recorded.
Timepoint [1] 372175 0
Data analytics downloaded at post-intervention (Week 12).
Secondary outcome [2] 372176 0
Flourishing Scale
Timepoint [2] 372176 0
Baseline (Week 0), post-intervention (Week 12), 12-weeks post-intervention (Week 24).

Eligibility
Key inclusion criteria
18 years or over
Mobile phone with SMS capability
Internet access
Australian or New Zealand resident
Fluent in English
Acceptance to provide informed consent
Permission given for anonymous data to be used for research
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Inability to participate in moderate-intensity physical activity such as walking.

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)
Central randomisation by computer
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Repeated measures General Linear Modelling (GLM) to test for group effects, time effects and group versus time interactions. Cohen’s d used to calculate effect sizes.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
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] 21660 0
New Zealand
State/province [1] 21660 0

Funding & Sponsors
Funding source category [1] 303175 0
Charities/Societies/Foundations
Name [1] 303175 0
South Pacific Division of the Seventh-day Adventist church
Address [1] 303175 0
183 Fox Valley Rd, Wahroonga, NSW 2076
Country [1] 303175 0
Australia
Primary sponsor type
University
Name
Avondale College of Higher Education
Address
287 Freemans Drive, Cooranbong, NSW 2265
Country
Australia
Secondary sponsor category [1] 303185 0
None
Name [1] 303185 0
Address [1] 303185 0
Country [1] 303185 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303737 0
Avondale College of Higher Education Human Research Ethics Committee
Ethics committee address [1] 303737 0
287 Freemans Drive, Cooranbong, NSW 2265
Ethics committee country [1] 303737 0
Australia
Date submitted for ethics approval [1] 303737 0
03/07/2018
Approval date [1] 303737 0
17/07/2018
Ethics approval number [1] 303737 0
2018.09

Summary
Brief summary
Mental health is in global jeopardy and devising efficacious promotive, preventative and curative solutions is paramount. In a progressively digital culture, program designers are replacing face-to-face (F2F) intervention delivery in favour of increasingly sophisticated online and mobile options. The paradigm shift overcomes numerous obstacles of inaccessibility, yet, online delivery poses unique challenges regarding the interrelated factors of adherence and human support. While human interaction is an intrinsic element of F2F interventions, program designers must evaluate how to add the human support component (e.g. dosage, type) back in to online programs to optimise adherence and outcome measures.

This study will explore what influence graded levels of human support have on the outcomes of and adherence to an online, lifestyle-based mental health intervention. Participants will be randomly assigned to three Arms, differentiated by variant levels of human support: Arm 1 – standard online program with no additional human support; Arm 2 – same standard program as Arm 1 with additional personalised SMS support; Arm 3 - same standard program as Arm 1 with additional weekly online group discussion (i.e. videoconference). Measures of mental health and wellbeing will be collected for all participants at pre- and post-intervention and comparisons made between the Arms. Adherence to the intervention will also be compared between the Arms.

This study will contribute to an evidence-based rationale for intervention planning, to maximise program efficacy through optimal human support and adherence. The study will also inform the optimal levels of human support when administering online interventions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94622 0
A/Prof Darren Morton
Address 94622 0
Lifestyle Research Centre, Avondale College of Higher Education.
287 Freemans Drive, Cooranbong, NSW 2265
Country 94622 0
Australia
Phone 94622 0
+61 412287138
Fax 94622 0
Email 94622 0
darren.morton@avondale.edu.au
Contact person for public queries
Name 94623 0
A/Prof Darren Morton
Address 94623 0
Lifestyle Research Centre, Avondale College of Higher Education.
287 Freemans Drive, Cooranbong, NSW 2265
Country 94623 0
Australia
Phone 94623 0
+61 412287138
Fax 94623 0
Email 94623 0
darren.morton@avondale.edu.au
Contact person for scientific queries
Name 94624 0
A/Prof Darren Morton
Address 94624 0
Lifestyle Research Centre, Avondale College of Higher Education.
287 Freemans Drive, Cooranbong, NSW 2265
Country 94624 0
Australia
Phone 94624 0
+61 412287138
Fax 94624 0
Email 94624 0
darren.morton@avondale.edu.au

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?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 2715 0
Ethical approval
Citation [1] 2715 0
Link [1] 2715 0
Email [1] 2715 0
Other [1] 2715 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary