ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12626000132347

Ethics application status

Approved

Date submitted

19/12/2025

Date registered

3/02/2026

Date last updated

22/07/2026

Date data sharing statement initially provided

3/02/2026

Type of registration

Prospectively registered

Titles & IDs

Public title

Longitudinal collection of data to inform the Things You Do/Big 5 model of mental health

Scientific title

Longitudinal collection of data to inform the Things You Do/Big 5 model of mental health in Australians aged 16 and over

Additional trial identifiers [1]

None

Universal Trial Number (UTN)

Trial acronym

Related trial records

Health condition

Health condition(s) studied:

Mental health

Condition category

Condition code

Mental Health

Anxiety

Mental Health

Depression

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of the intervention or exposure

The primary objective of this observational study is trial is to collect sufficient data to answer important research questions about the relationship between daily actions, mental health and factors that may affect these. Data will be collected from a broad range of people, about their activities, personal characteristics, cognitive characteristics and mental health outcomes. This information will be used to inform, develop and test the Things You Do (TYD) / Big 5 model of mental health.
Participants will be asked to respond to online questionnaires, including: Demographics (19 items); Things You Do Questionnaire (15 items); Physical and Mental Health Questions (6 items); Patient Health Questionnaire (9 items); Generalised Anxiety Disorder (7 items); Kessler-10plus (14 items); Personality Inventory (10 items); Health Locus of Control Scale (7 items); Overall Life Satisfaction (1 item); Modified Social Stress Scale (15 items); Reflections Questionnaire (3 items); EuroQol Scale (5 items); Generalized Self-Efficacy Scale (10 items); Life Satisfaction and Purpose (2 items). Total expected completion time: 20 to 25 minutes, Participants will be invited to opt-in to complete monthly questionnaires for up 24 months.

Intervention code [1]

Not applicable

Description of the comparator or control

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Daily activities

Timepoint [1]

Measured at baseline as cross sectional single time point survey, Participants will then be invited to register to receive monthly questionnaires, for 24 months.

Secondary outcome [1]

Depression

Timepoint [1]

Measured at baseline as cross sectional single time point survey, Participants will then be invited to register to receive monthly questionnaires, for 24 months.

Secondary outcome [2]

Anxiety

Timepoint [2]

Measured at baseline as cross sectional single time point survey, Participants will then be invited to register to receive monthly questionnaires, for 24 months.

Secondary outcome [3]

General psychological distress

Timepoint [3]

Baseline and then every second month for 24 months

Secondary outcome [4]

Overall health

Timepoint [4]

6-monthly for 24 months

Secondary outcome [5]

Overall health

Timepoint [5]

6-monthly for up to 24 months

Secondary outcome [6]

Self-efficacy

Timepoint [6]

6-monthly for up to 24 months

Secondary outcome [7]

Measure of personality traits

Timepoint [7]

6-monthly for up to 24 months

Eligibility

Key inclusion criteria

Inclusion criteria are: (a) Australian resident, and (b) aged 16 or over.

Minimum age

16 Years

Maximum age

No limit

Sex

Both males and females

Healthy volunteers

Yes

Key exclusion criteria

Unable to read and understand English.

Study design

Purpose

Duration

Selection

Timing

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

31/07/2026

Actual

Date of last participant enrolment

Anticipated

1/07/2028

Actual

Date of last data collection

Anticipated

1/01/2030

Actual

Sample size

Target

5000

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

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

Funding & Sponsors

Funding source category [1]

University

Name [1]

Macquarie University

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

Macquarie University

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Macquarie University Human Research Ethics Committee Medical Sciences

Ethics committee address [1]

https://www.mq.edu.au/research/ethics-integrity-and-policies/ethics/human-ethics

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/12/2025

Approval date [1]

09/12/2025

Ethics approval number [1]

Summary

Brief summary

The primary objective of this protocol is to collect data from a broad range of people, about their activities, personal characteristics, circumstances, cognitive characteristics and mental health outcomes. This information will be used to inform, develop and test the TYD model of mental health. 
Key questions to be explored include the:
1.	Relationship between the frequency of specific actions and mental health outcomes
2.	Relationship between (1) and personality and demographic characteristics
3.	Relationship between (1) and (2) and cognitive characteristics (for example, learning and memory, and attributional style) 
4.	Relationship between (1), (2) and (3) and stressors over time (longitudinal modelling).
These questions will improve our understanding of the factors that mediate the relationship between our daily actions and our mental health for different groups of people. It will help determine whether there are optimal combinations of actions for different groups of people and conversely, whether there are combinations that indicate a person is at particular risk of symptoms or even chronicity of symptoms. Our ability to validly answer these questions requires large and diverse samples.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Nickolai Titov

Address

2 Technology Place Macquarie University NSW 2109

Country

Australia

Phone

+61488991122

Fax

[email protected]

Contact person for public queries

Name

Nickolai Titov

Address

2 Technology Place Macquarie University NSW 2109

Country

Australia

Phone

+61488991122

Fax

[email protected]

Contact person for scientific queries

Name

Nickolai Titov

Address

2 Technology Place Macquarie University NSW 2109

Country

Australia

Phone

+61488991122

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically