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Trial registered on ANZCTR


Registration number
ACTRN12621000827831p
Ethics application status
Submitted, not yet approved
Date submitted
28/05/2021
Date registered
29/06/2021
Date last updated
29/06/2021
Date data sharing statement initially provided
29/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
‘Things You Do’: a randomized controlled trial of a minimal psychological intervention in people seeking mental health services
Scientific title
‘Things You Do’: a randomized controlled trial of efficacy of a minimal psychological intervention in people seeking mental health services
Secondary ID [1] 304345 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anxiety 322105 0
depression 322106 0
Condition category
Condition code
Mental Health 319820 319820 0 0
Anxiety
Mental Health 319821 319821 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two intervention arms in this trial:
1. Things You Do Intervention
2. Things You Do Intervention PLUS Text Message Reminders.

Both interventions are 4-weeks in duration and are self-guided (i.e., no scheduled contact with a clinician). The trial is held at MindSpot Clinic, and will be delivered through the current patient website (i.e., individually).

Group 1 will receive:
1. On day 1, participants will be able to access a report outlining their scores on the 31-item Things You Do Questionnaire. This questionnaire lists activities associated with emotional wellbeing (e.g., I treated myself with respect, I had a meaningful conversation with someone). This report will provide a guide for increasing the frequency of these listed activities (i.e., practical examples) as a way to improve symptoms of anxiety and/or depression. The report will be available to download for the entire duration of the intervention.

Group 2 will receive:
1. The same report, tailored to their scores.
2. A text message reminding them to engage in an activity listed on the questionnaire. Each text message will be different, and 20 messages will be sent across the entire intervention (i.e., once per day, Monday to Friday, for four weeks).

The questionnaire has been previously used in two large surveys (n = 3789, n = 3048). The 31-items are taken from a larger 96-item questionnaire set. The 31-items were the most strongly associated with anxiety and depression scores. This data is currently being prepared for publication. The questionnaire takes approximately 5-10 minutes to complete.

Participants will not be instructed to spend a set amount of time completing the activities. Instead, it is recommended that the activities are completed three to four times per week (i.e., more than half the days). The time taken to complete the activities is at the participants' discretion.

The only strategy used to monitor adherence will be whether the participant downloads the resource from the website.
Intervention code [1] 320700 0
Treatment: Other
Intervention code [2] 320901 0
Behaviour
Intervention code [3] 320902 0
Treatment: Devices
Comparator / control treatment
Waitlist control group. The control group will receive access to the intervention (either arm) after a 4-week waiting period. This group will not receive a Things You Do report or text message reminders.
Control group
Active

Outcomes
Primary outcome [1] 327685 0
Anxiety - Generalized Anxiety Disorder 7-item
Timepoint [1] 327685 0
Baseline
2 weeks post-intervention commencement
4 weeks post-intervention commencement (primary endpoint)
12 weeks post-intervention commencement
Primary outcome [2] 327686 0
Depression - Patient Health Questionnaire-9 item
Timepoint [2] 327686 0
Baseline
2 weeks post-intervention commencement
4 weeks post-intervention commencement (primary endpoint)
12 weeks post-intervention commencement
Primary outcome [3] 327687 0
Disability - Sheehan Disability Scale-3 item
Timepoint [3] 327687 0
Baseline
2 weeks post-intervention commencement
4 weeks post-intervention commencement (primary endpoint)
12 weeks post-intervention commencement
Secondary outcome [1] 396240 0
Life Satisfaction - Satisfaction with Life Scale-5 item
Timepoint [1] 396240 0
Baseline
2 weeks post-intervention commencement
4 weeks post-intervention commencement
12 weeks post-intervention commencement

Eligibility
Key inclusion criteria
(a) Australian resident
(b) Are aged 18 years or older.
(c) Participants seeking mental health services at MindSpot Clinic
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) Actively suicidal or unable to keep themselves safe
(b) Living outside of Australia
(c) Currently enrolled in a different MindSpot treatment course
(d) Unable to read and understand English.

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)
Allocation to group will be blacked out in a spreadsheet pre-filled with a randomized allocation sequence. The group will not be revealed until enrolment is complete.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 308716 0
University
Name [1] 308716 0
MindSpot Clinic, Macquarie University
Address [1] 308716 0
73 Talavera Road
Macquarie Park NSW 2109
Country [1] 308716 0
Australia
Primary sponsor type
University
Name
MindSpot Clinic, Macquarie University
Address
73 Talavera Road
Macquarie Park NSW 2109
Country
Australia
Secondary sponsor category [1] 309608 0
None
Name [1] 309608 0
Nil
Address [1] 309608 0
Nil
Country [1] 309608 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308641 0
Human Research Ethics Committee, Macquarie University
Ethics committee address [1] 308641 0
Macquarie University
Macquarie Park NSW 2109
Ethics committee country [1] 308641 0
Australia
Date submitted for ethics approval [1] 308641 0
14/05/2021
Approval date [1] 308641 0
Ethics approval number [1] 308641 0

Summary
Brief summary
The primary aim of this project is to examine the feasibility and efficacy of the Things You Do Intervention on anxiety, depression, and disability outcomes. The intervention encourages participants to increase how frequently they engage in a list of activities (e.g., treating self with respect, eating a healthy meal). The intervention will e delivered via a PDF resource with or without text message reminders, and will be compared to a waitlist group. We anticipate that this intervention will lead to reductions in anxiety, depression, and disability.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111402 0
Dr Madelyne Bisby
Address 111402 0
MindSpot Clinic
73 Talavera Road
Macquarie Park NSW 2109
Country 111402 0
Australia
Phone 111402 0
+61 2 98508724
Fax 111402 0
Email 111402 0
madelyne.bisby@mq.edu.au
Contact person for public queries
Name 111403 0
Dr Madelyne Bisby
Address 111403 0
MindSpot Clinic
73 Talavera Road
Macquarie Park NSW 2109
Country 111403 0
Australia
Phone 111403 0
+61 2 98508724
Fax 111403 0
Email 111403 0
madelyne.bisby@mq.edu.au
Contact person for scientific queries
Name 111404 0
Dr Madelyne Bisby
Address 111404 0
MindSpot Clinic
73 Talavera Road
Macquarie Park NSW 2109
Country 111404 0
Australia
Phone 111404 0
+61 2 98508724
Fax 111404 0
Email 111404 0
madelyne.bisby@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?
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 11798 0
Ethical approval
Citation [1] 11798 0
Link [1] 11798 0
Email [1] 11798 0
madelyne.bisby@mq.edu.au
Other [1] 11798 0
Attachment [1] 11798 0
Type [2] 11799 0
Informed consent form
Citation [2] 11799 0
Link [2] 11799 0
Email [2] 11799 0
madelyne.bisby@mq.edu.au
Other [2] 11799 0
Attachment [2] 11799 0
Summary results
No Results