Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000993190
Ethics application status
Approved
Date submitted
1/07/2019
Date registered
12/07/2019
Date last updated
12/07/2019
Date data sharing statement initially provided
12/07/2019
Date results information initially provided
12/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of an online multimodal intervention for mental health promotion.
Scientific title
The effectiveness of an online multimodal intervention for mental health promotion in healthy adults: A randomised controlled trial.
Secondary ID [1] 298633 0
None
Universal Trial Number (UTN)
U1111-1236-2314
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health 313504 0
Condition category
Condition code
Mental Health 311932 311932 0 0
Depression
Public Health 311933 311933 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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] 314898 0
Lifestyle
Comparator / control treatment
No treatment.

The control group will not engage in the lifestyle intervention, but the program will be made available free-of-charge to participants in the control group after the completion of the study (ie. after the 12 week post-intervention follow-up, which corresponds to 24 weeks from baseline).
Control group
Active

Outcomes
Primary outcome [1] 320597 0
The 36-Item Short Form Survey (SF-36)
Timepoint [1] 320597 0
Baseline (Week 0), post-intervention (Week 12, primary end-point), 12-weeks post-intervention (Week 24).
Primary outcome [2] 320598 0
The Depression Anxiety and Stress Scales (DASS-21)
Timepoint [2] 320598 0
Baseline (Week 0), post-intervention (Week 12, primary end-point), 12-weeks post-intervention (Week 24).
Primary outcome [3] 320599 0
The Satisfaction With Life Scale (SWLS)
Timepoint [3] 320599 0
Baseline (Week 0), post-intervention (Week 12, primary end-point), 12-weeks post-intervention (Week 24).
Secondary outcome [1] 372172 0
Flourishing Scale
Timepoint [1] 372172 0
Baseline (Week 0), post-intervention (Week 12), 12-weeks post-intervention (Week 24).

Eligibility
Key inclusion criteria
18 years or over
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
Sex
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
Completed
Date of first participant enrolment
Anticipated
Actual
25/07/2017
Date of last participant enrolment
Anticipated
Actual
31/08/2017
Date of last data collection
Anticipated
Actual
25/02/2018
Sample size
Target
500
Accrual to date
Final
425
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 21659 0
New Zealand
State/province [1] 21659 0

Funding & Sponsors
Funding source category [1] 303173 0
Charities/Societies/Foundations
Name [1] 303173 0
South Pacific Division of the Seventh-day Adventist church
Country [1] 303173 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] 303184 0
None
Name [1] 303184 0
Address [1] 303184 0
Country [1] 303184 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303735 0
Avondale College of Higher Education Human Research Ethics committee
Ethics committee address [1] 303735 0
287 Freemans Drive, Cooranbong, NSW 2265
Ethics committee country [1] 303735 0
Australia
Date submitted for ethics approval [1] 303735 0
03/07/2017
Approval date [1] 303735 0
17/07/2017
Ethics approval number [1] 303735 0
2017:13

Summary
Brief summary
There is a call to address population-level mental health through the use of integrative approaches that include non-pharmacological strategies such as lifestyle interventions, education programs and psychological therapies. Advances in online technology presents an opportunity to provide mental health promotion and primary prevention strategies that are easily accessible, available population-wide, and that overcome barriers with face-to-face interventions and the stigma of mental health disorders. Online interventions can also provide low-cost solutions for dissemination.

This study investigates the effectiveness of a ten-week online multimodal intervention, incorporating both Positive Psychology and Lifestyle Medicine strategies, for improving the mental health and emotional wellness of a community-based cohort. Participants are randomly assigned to an intervention or control group and measures of mental health and wellbeing are assessed at times corresponding to pre-intervention, post-intervention and 12 weeks post-intervention. Comparative changes in the measures of mental health and wellbeing are made between the intervention and control groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94614 0
A/Prof Darren Morton
Address 94614 0
Lifestyle Research Centre, Avondale College of Higher Education, 287 Freemans Drive, Cooranbong, NSW 2265
Country 94614 0
Australia
Phone 94614 0
+61 412287138
Fax 94614 0
Email 94614 0
[email protected]
Contact person for public queries
Name 94615 0
A/Prof Darren Morton
Address 94615 0
Lifestyle Research Centre, Avondale College of Higher Education, 287 Freemans Drive, Cooranbong, NSW 2265
Country 94615 0
Australia
Phone 94615 0
+61 412287138
Fax 94615 0
Email 94615 0
[email protected]
Contact person for scientific queries
Name 94616 0
A/Prof Darren Morton
Address 94616 0
Lifestyle Research Centre, Avondale College of Higher Education, 287 Freemans Drive, Cooranbong, NSW 2265
Country 94616 0
Australia
Phone 94616 0
+61 412287138
Fax 94616 0
Email 94616 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2716Ethical approval    377889-(Uploaded-01-07-2019-16-40-21)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe effectiveness of an online interdisciplinary intervention for mental health promotion: a randomized controlled trial.2021https://dx.doi.org/10.1186/s40359-021-00577-8
N.B. These documents automatically identified may not have been verified by the study sponsor.