Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000827831
Ethics application status
Approved
Date submitted
28/05/2021
Date registered
29/06/2021
Date last updated
25/10/2023
Date data sharing statement initially provided
29/06/2021
Date results information initially provided
25/10/2023
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
All participants will receive the 'Things You Do' Intervention PLUS Text Message Reminders. The intervention is 4-weeks in duration and is self-guided (i.e., no scheduled contact with a clinician). The trial is held at the eCentreClinic, and will be delivered individually.

Participants will receive:
1. Access to a brief lesson which outlines the 'things you do', the link between activity levels and mental health, and encourages people to increase their 'things you do'.
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 21-items are taken from a larger 96-item questionnaire set. The 21-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 accesses the lesson or downloads the lesson 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 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), and 16 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), and 16 weeks post-intervention commencement
Primary outcome [3] 327687 0
Days out of role
Timepoint [3] 327687 0
Baseline, 2 weeks post-intervention commencement, 4 weeks post-intervention commencement (primary endpoint), and 16 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 (primary endpoint), and 16 weeks post-intervention commencement

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?
No
Key exclusion criteria
(a) Actively suicidal or unable to keep themselves safe
(b) Living outside of Australia
(c) 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)
For therapist-enrolled participants, they will be allocated based on a randomized sequence pre-filled and blacked out in a spreadsheet. The group will not be revealed until enrolment is complete.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
For therapist-enrolled participants, they will be allocated according to 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
Completed
Date of first participant enrolment
Anticipated
25/07/2022
Actual
7/11/2022
Date of last participant enrolment
Anticipated
Actual
5/04/2023
Date of last data collection
Anticipated
Actual
15/09/2023
Sample size
Target
250
Accrual to date
Final
349
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
eCentreClinic, Macquarie University
Country [1] 308716 0
Australia
Primary sponsor type
University
Name
eCentreClinic, 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
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
23/07/2021
Ethics approval number [1] 308641 0
Ethics committee name [2] 310236 0
Macquarie University Human Research Ethics Committee
Ethics committee address [2] 310236 0
Macquarie University
Ryde NSW 2109
Ethics committee country [2] 310236 0
Australia
Date submitted for ethics approval [2] 310236 0
14/05/2021
Approval date [2] 310236 0
23/07/2021
Ethics approval number [2] 310236 0
NA

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 lesson with 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
The trial is being restarted in the eCentreClinic, Macquarie University, due to difficulties with participant recruitment and the complexities of managing a clinical research trial within a routine care mental health service. This change was made after 114 participants were enrolled in the old design but prior to enrolment commencement for the restarted trial.

Contacts
Principal investigator
Name 111402 0
Dr Madelyne Bisby
Address 111402 0
eCentreClinic, 73 Talavera Road Macquarie Park NSW 2109
Country 111402 0
Australia
Phone 111402 0
+61 2 98508724
Fax 111402 0
Email 111402 0
[email protected]
Contact person for public queries
Name 111403 0
Dr Madelyne Bisby
Address 111403 0
eCentreClinic, 73 Talavera Road Macquarie Park NSW 2109
Country 111403 0
Australia
Phone 111403 0
+61 2 98508724
Fax 111403 0
Email 111403 0
[email protected]
Contact person for scientific queries
Name 111404 0
Dr Madelyne Bisby
Address 111404 0
eCentreClinic, 73 Talavera Road Macquarie Park NSW 2109
Country 111404 0
Australia
Phone 111404 0
+61 2 98508724
Fax 111404 0
Email 111404 0
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11798Ethical approval  [email protected]
11799Informed consent form  [email protected]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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