Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000163606
Ethics application status
Approved
Date submitted
3/02/2023
Date registered
17/02/2023
Date last updated
9/02/2024
Date data sharing statement initially provided
17/02/2023
Date results information initially provided
9/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Things You Do (TYD) Open Trial: the effects of changing the frequency of daily actions on mental health in healthy adults
Scientific title
Things You Do (TYD) Open Trial: the effects of changing the frequency of daily actions on mental health in healthy adults
Secondary ID [1] 308908 0
NA
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12621000827831 was the first randomised controlled trial of the Things You Do Course.

This study is designed to follow ACTRN12621000827831 and test the reverse (i.e., does decreasing the frequency of TYD actions impact mental health?). The Things You Do Course tested in ACTRN12621000827831 will be used in the current study.

Health condition
Health condition(s) or problem(s) studied:
anxiety 328909 0
depression 328910 0
Condition category
Condition code
Mental Health 325899 325899 0 0
Anxiety
Mental Health 325900 325900 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project is a two-stage trial which involves participants being encouraged to 1) decrease the frequency of a number of important activities, and then 2) increase the frequency of the same behaviours. The trial is held at the eCentreClinic, and will be delivered individually.

To begin, an initial “vanguard cohort” of 5 participants will be used to test the feasibility and safety of the protocol prior to further recruitment. Then, a further 21 participants will be recruited. All 26 participants will be included in the final analysis.

In Phase 1 (four weeks duration), participants will be instructed to reduce the frequency of activities previously identified as strongly linked to good psychological health (e.g., healthy thinking, social activities) to less than 2 times a week. This will involve a PDF resource encouraging people to reduce the activities which has been specifically designed for this study. We will monitor the frequency of these behaviours with weekly questionnaires.

There is no wash out period between Phase 1 and Phase 2. In Phase 2 (four weeks duration), participants will be instructed to increase the frequency of these activities to at least five times a week. This will involve access to the 'Things You Do' Course, an online treatment which consists of one lesson, downloadable Activity Planner & Activity Suggestions Guides, and daily text messages Monday to Friday. The downloadable guides have been designed specifically for this study and the text messages encourage participants to engage in Things You Do activities (e.g., “What brings you joy? Do at least one thing today that makes you feel good! Your daily actions matter”). The Course is self-guided but participants will be monitored by a psychologist throughout treatment.

The time taken to complete the activities is at the participants' discretion. The only strategy used to monitor adherence to the Course materials will be whether the participant accesses the lesson or downloads the lesson from the website.
Intervention code [1] 325352 0
Treatment: Other
Intervention code [2] 325353 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333728 0
Anxiety - Generalized Anxiety Disorder 7-item
Timepoint [1] 333728 0
Baseline
Weekly during Phase 1 (i.e., Weeks 1 to 4)
Weekly during Phase 2 (i.e., Weeks 5 to 8)
9 weeks after baseline (primary timepoint)
17 weeks after baseline
Primary outcome [2] 333729 0
Depression - Patient Health Questionnaire-9 item
Timepoint [2] 333729 0
Baseline
Weekly during Phase 1 (i.e., Weeks 1 to 4)
Weekly during Phase 2 (i.e., Weeks 5 to 8)
9 weeks after baseline (primary timepoint)
17 weeks after baseline
Primary outcome [3] 333730 0
Frequency of daily actions - Things You Do Questionnaire 21-item
Timepoint [3] 333730 0
Baseline
Weekly during Phase 1 (i.e., Weeks 1 to 4)
Weekly during Phase 2 (i.e., Weeks 5 to 8)
9 weeks after baseline (primary timepoint)
17 weeks after baseline
Secondary outcome [1] 418081 0
Disability - Days out of Role (a single item question from the K10 Plus).
Timepoint [1] 418081 0
Baseline
Weekly during Phase 1 (i.e., Weeks 1 to 4)
Weekly during Phase 2 (i.e., Weeks 5 to 8)
9 weeks after baseline
17 weeks after baseline
Secondary outcome [2] 418082 0
Life Satisfaction: Satisfaction with Life Scale - 5 item
Timepoint [2] 418082 0
Baseline
5-weeks after baseline
9 weeks after baseline
17 weeks after baseline
Secondary outcome [3] 418365 0
Feasibility - PRIMARY OUTCOME. This will be determined in the 'vanguard cohort' of 5 participants. Did participants decrease the frequency of daily actions (assessed using the TYDQ-21) from baseline?
Timepoint [3] 418365 0
5-weeks after baseline (primary timepoint)
Secondary outcome [4] 418366 0
Safety - PRIMARY OUTCOME. This will be determined in the 'vanguard cohort' of 5 participants. Did participants report any adverse effects due to decreasing daily actions?

Adverse events include an increase in self-reported symptoms of depression/anxiety, as measured by the study questionnaires. This will be checked on a weekly basis.
Timepoint [4] 418366 0
5-weeks post-baseline (primary timepoint)

Eligibility
Key inclusion criteria
Inclusion criteria are: (a) Australian resident, and (b) aged 18 or over.

Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria are: (a) Moderate or greater symptoms of depression as defined by a score of greater than or equal to 10 on the Patient Health Questionnaire – 9 Item (PHQ-9) or moderate or greater symptoms of anxiety as defined by a score of greater than or equal to 8 on the Generalized Anxiety Disorder – 7 Item (GAD-7), (b) not living in Australia, (c) unable to read and understand English, (d) currently receiving psychological treatment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable - one group
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable - one group
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
The consistency of results led to the early termination of the trial
Date of first participant enrolment
Anticipated
20/03/2023
Actual
13/04/2023
Date of last participant enrolment
Anticipated
Actual
12/07/2023
Date of last data collection
Anticipated
Actual
27/11/2023
Sample size
Target
26
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313116 0
University
Name [1] 313116 0
eCentreClinic, Macquarie University
Country [1] 313116 0
Australia
Primary sponsor type
University
Name
eCentreClinic, Macquarie University
Address
16 University Ave, Macquarie University NSW 2109
Country
Australia
Secondary sponsor category [1] 314816 0
None
Name [1] 314816 0
Nil
Address [1] 314816 0
Nil
Country [1] 314816 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312365 0
Human Research Ethics Committee, Macquarie University
Ethics committee address [1] 312365 0
Macquarie University
Macquarie Park NSW 2109
Ethics committee country [1] 312365 0
Australia
Date submitted for ethics approval [1] 312365 0
Approval date [1] 312365 0
08/12/2022
Ethics approval number [1] 312365 0

Summary
Brief summary
The primary aim of this study is to understand the associations between "Things You Do" activities and changes in mental health symptoms. In this two-phase project, participants will be encouraged to restrict the frequency of these behaviours for 4-weeks and then increase these behaviours for the next 4-weeks. In Phase 2, all participants will receive access to the "Things You Do Course", a one-lesson course alongside daily text message reminders.

We expect that people will report a increase in depression and anxiety symptoms during Phase 1 (restriction) and then a decrease in these symptoms during Phase 2 (treatment).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124398 0
Prof Nickolai Titov
Address 124398 0
eCentreClinic, 16 University Ave, Macquarie University NSW 2109
Country 124398 0
Australia
Phone 124398 0
+61 2 9850 8724
Fax 124398 0
Email 124398 0
contact@ecentreclinic.org
Contact person for public queries
Name 124399 0
Prof Nickolai Titov
Address 124399 0
eCentreClinic, 16 University Ave, Macquarie University NSW 2109
Country 124399 0
Australia
Phone 124399 0
+61 2 9850 8724
Fax 124399 0
Email 124399 0
contact@ecentreclinic.org
Contact person for scientific queries
Name 124400 0
Prof Nickolai Titov
Address 124400 0
eCentreClinic, 16 University Ave, Macquarie University NSW 2109
Country 124400 0
Australia
Phone 124400 0
+61 2 9850 8724
Fax 124400 0
Email 124400 0
contact@ecentreclinic.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified data, such as self-reported depression symptoms on the PHQ-9.
When will data be available (start and end dates)?
After the cessation of the trial (anticipated late 2023) with no anticipated end date.
Available to whom?
Investigators from research centres upon reasonable request.
Available for what types of analyses?
Most analyses will be considered (e.g., treatment outcome individual patient data meta-analyses)
How or where can data be obtained?
Upon reasonable request via email to the primary investigator Prof Nickolai Titov (nick.titov@mq.edu.au).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18231Informed consent form    385335-(Uploaded-03-02-2023-12-05-50)-Study-related document.pdf
18232Ethical approval    385335-(Uploaded-03-02-2023-12-06-52)-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
No additional documents have been identified.