Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001491550
Ethics application status
Approved
Date submitted
27/11/2024
Date registered
20/12/2024
Date last updated
20/12/2024
Date data sharing statement initially provided
20/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Restricting and then resuming certain behaviors and the effects on symptoms of anxiety and depression
Scientific title
Things You Do (TYD) RCT #3: Randomised Controlled Trial of the Restriction/Resume Method Comparing the Effect of TYD vs. Waitlist Control (“Restriction/Resume RCT”) on Symptoms of Anxiety and Depression in Healthy Adults
Secondary ID [1] 313473 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anxiety 335881 0
depression 335882 0
Condition category
Condition code
Mental Health 332467 332467 0 0
Anxiety
Mental Health 332468 332468 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The research design is a parallel group randomised controlled trial.
Applicants will be randomly allocated to one of two conditions (one intervention and one control), with randomisation stratifying for gender, age and symptom severity.
Participants will be randomly allocated to receive one of two conditions. All groups will complete symptom and activity questionnaires each week. The intervention group will follow the protocol previously approved by the MQ HREC (520221263243784):

1. TYD Group.
a. During Phase 1 (2 weeks), Baseline Phase, participants will be instructed to continue to perform their usual activities.
b. During Phase 2 (2 weeks), Restriction Phase, participants will be instructed to reduce the frequency they perform the actions listed on the TYD-15 item questionnaire (TYD-15) to 2 times each week. Example items include: "I kept a healthy daily routine"; "I went to bed and woke up at a regular time"; "I prepared and ate a healthy meal".

c. During Phase 3 (5 weeks), Recovery Phase, participants will be instructed to resume the frequency they perform the actions that they restricted in Phase 2 to 5 times each week. Behaviour will be prompted using automated daily text messages, which were approved by the MQ (HREC 5201831843909) for an earlier study. Adherence throughout the phases will be monitored via the symptom and activity questionnaires administered each week.

Intervention code [1] 330047 0
Behaviour
Comparator / control treatment
Control Group: This condition will complete the questionnaires at the same times points as the intervention group. At the end of the trial they will receive information and advice about using the TYD to support their mental health in the long-term. At post-treatment, all participants will be informed about how they can access further treatment and care via email. This will include recommending speaking to their GP, contacting Lifeline, or contacting MindSpot for free assessment and treatment. This information will be provided by email and verbally during a final telephone call. Participants will also be invited to contact the research team if concerned about their mental health.
Control group
Active

Outcomes
Primary outcome [1] 340005 0
Anxiety at post-treatment
Timepoint [1] 340005 0
Anxiety will be assessed using the GAD-7 at baseline (pre-intervention), and weekly during the intervention. Post-treatment at week 9 will be the primary endpoint.
Primary outcome [2] 340006 0
Depression at post-treatment
Timepoint [2] 340006 0
Depression will be assessed using the PHQ-9 at baseline (pre-intervention), and weekly during the intervention. Post-treatment at week 9 will be the primary endpoint.
Secondary outcome [1] 442277 0
Nil
Timepoint [1] 442277 0
Nil

Eligibility
Key inclusion criteria
(a) Australian resident;
(b) Are aged 18 years or older.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People who:.
1. Have moderate or higher levels of symptoms of anxiety or depression
2. Are not living in Australia
2. Are unable to read or understand English
3. Are currently receiving psychological treatment
4. At risk of suicide or self-harm


Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
randomisation by centralised computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomisation stratified for gender, age and symptom severity
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2025
Actual
Date of last participant enrolment
Anticipated
31/03/2025
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 317912 0
Other Collaborative groups
Name [1] 317912 0
WA Primary Health Alliance
Country [1] 317912 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Country
Australia
Secondary sponsor category [1] 320258 0
None
Name [1] 320258 0
Address [1] 320258 0
Country [1] 320258 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316599 0
Macquarie University Human Research Ethics Committee Medical Sciences
Ethics committee address [1] 316599 0
Ethics committee country [1] 316599 0
Australia
Date submitted for ethics approval [1] 316599 0
20/06/2024
Approval date [1] 316599 0
29/08/2024
Ethics approval number [1] 316599 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138370 0
Prof Nickolai Titov
Address 138370 0
MindSpot, 2 Technology Place Macquarie University. NSW 2109
Country 138370 0
Australia
Phone 138370 0
+61 2 98509901
Fax 138370 0
Email 138370 0
nick.titov@mq.edu.au
Contact person for public queries
Name 138371 0
Lauren Staples
Address 138371 0
MindSpot, 2 Technology Place Macquarie University. NSW 2109
Country 138371 0
Australia
Phone 138371 0
+61 2 98509971
Fax 138371 0
Email 138371 0
lauren.staples@mq.edu.au
Contact person for scientific queries
Name 138372 0
Lauren Staples
Address 138372 0
MindSpot, 2 Technology Place Macquarie University. NSW 2109
Country 138372 0
Australia
Phone 138372 0
+61 2 98509971
Fax 138372 0
Email 138372 0
lauren.staples@mq.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?

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.