ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

U1111-1236-2358

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Mental Health

Condition category

Condition code

Mental Health

Depression

Public Health

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]

Lifestyle

Intervention code [2]

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]

The 36-Item Short Form Survey (SF-36)

Timepoint [1]

Baseline (Week 0), post-intervention (Week 12, primary endpoint), 12-weeks post-intervention (Week 24).

Primary outcome [2]

The Depression Anxiety and Stress Scales (DASS-21)

Timepoint [2]

Baseline (Week 0), post-intervention (Week 12, primary endpoint), 12-weeks post-intervention (Week 24).

Primary outcome [3]

The Satisfaction With Life Scale (SWLS)

Timepoint [3]

Baseline (Week 0), post-intervention (Week 12, primary endpoint), 12-weeks post-intervention (Week 24).

Secondary outcome [1]

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]

Data analytics downloaded at post-intervention (Week 12).

Secondary outcome [2]

Flourishing Scale

Timepoint [2]

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

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

Stopped early

Data analysis

Data collected is being analysed

Reason for early stopping/withdrawal

Participant recruitment difficulties

Date of first participant enrolment

Anticipated

Actual

1/07/2018

Date of last participant enrolment

Anticipated

Actual

28/09/2018

Date of last data collection

Anticipated

Actual

24/03/2019

Sample size

Target

450

Accrual to date

Final

320

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

South Pacific Division of the Seventh-day Adventist church

Address [1]

183 Fox Valley Rd, Wahroonga, NSW 2076

Country [1]

Australia

Primary sponsor type

University

Name

Avondale College of Higher Education

Address

287 Freemans Drive, Cooranbong, NSW 2265

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Avondale College of Higher Education Human Research Ethics Committee

Ethics committee address [1]

287 Freemans Drive, Cooranbong, NSW 2265

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

03/07/2018

Approval date [1]

17/07/2018

Ethics approval number [1]

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

A/Prof Darren Morton

Address

Lifestyle Research Centre, Avondale College of Higher Education.
287 Freemans Drive, Cooranbong, NSW 2265

Country

Australia

Phone

+61 412287138

Fax

[email protected]

Contact person for public queries

Name

A/Prof Darren Morton

Address

Lifestyle Research Centre, Avondale College of Higher Education.
287 Freemans Drive, Cooranbong, NSW 2265

Country

Australia

Phone

+61 412287138

Fax

[email protected]

Contact person for scientific queries

Name

A/Prof Darren Morton

Address

Lifestyle Research Centre, Avondale College of Higher Education.
287 Freemans Drive, Cooranbong, NSW 2265

Country

Australia

Phone

+61 412287138

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
2715	Ethical approval					377891-(Uploaded-01-07-2019-16-36-04)-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

Source	Title	Year of Publication	DOI
Embase	A web- And mobile app-based mental health promotion intervention comparing email, short message service, and videoconferencing support for a healthy cohort: Randomized comparative study.	2020	https://dx.doi.org/10.2196/15592
Embase	The influence of three modes of human support on attrition and adherence to a web- And mobile app-based mental health promotion intervention in a nonclinical cohort: Randomized comparative study.	2020	https://dx.doi.org/10.2196/19945

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically