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Trial registered on ANZCTR


Registration number
ACTRN12624000613505
Ethics application status
Approved
Date submitted
8/04/2024
Date registered
10/05/2024
Date last updated
10/05/2024
Date data sharing statement initially provided
10/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
SMS Wellbeing Trial for health professionals with symptoms of anxiety or depression.
Scientific title
Things You Do (TYD) RCT #2: Randomised Controlled Trial comparing the efficacy of TYD Intervention vs. Gratitude Intervention vs. Waitlist Control for reducing symptom severity in health professionals experiencing anxiety or depression (“SMS Wellbeing Trial”)
Secondary ID [1] 311903 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 333486 0
anxiety 333487 0
Condition category
Condition code
Mental Health 330163 330163 0 0
Anxiety
Mental Health 330164 330164 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly allocated to receive one of three conditions.

1. TYD Intervention (TYD-I). The TYD-I comprises brief psychoeducation about the importance of performing five types of actions (behaviours) to maintain good mental health. The five behaviours are based on previous research (Titov et al., 2022, JMIR Formative Research):
- Healthy Thinking
- Meaningful Activities
- Goals and Plans
- Healthy Habits
- Social Connections
Participants will be invited to read brief educational material, comprising a brief slide show of between 5 and 10 slides. The slides will contain background information for the TYD intervention and encourage efforts to increase healthy behaviours over the next 4 weeks. For the next four weeks, they will receive one SMS message each day at 10am (local time) nudging them to perform the TYD actions. All of the SMS messages contain information which is evidence-based and similar to the information that is available on most mental health websites. Adherence will be monitored primarily by participant self-report. Example SMS messages -
"What time is bedtime? Try and go to bed early at least twice this week. Sleep helps keep us healthy – physically and mentally. Healthy routines matter. "
"What do you find satisfying and meaningful? Even it’s as simple as a chore, make time for it today. Make sure you get your daily dose of satisfaction!"
"What would you like to achieve in the next 6 hrs? Make a note in your diary. We all need goals. "

2. Gratitude Intervention (GRAT-I). This intervention is based on principles and content from gratitude-based psychology. The GRAT-I comprises brief psychoeducation about the importance of gratitude in good mental health. Educational material will comprise a brief slide show of between 5 and 10 slides. The slides will contain background information for the GRAT intervention and have been developed specifically for this interventiion. Following the psychoeducation participants will receive SMS messages nudging the completion of gratitude-related actions each weekday for 4 weeks. The amount of educational content and the number of words will be similar to the TYD intervention. The SMS messages will also be sent at 10am each day. The main difference is that the educational content and SMS messages will target actions relevant to the participants’ specific intervention condition. Adherence will be monitored primarily by participant self-report.
Examples of gratitude-related actions include:
"Think about or write down three good things that have happened in the last 24 hours. Describe the event, and why you felt grateful.";
"What can you be grateful for each morning? Try to cultivate an attitude of gratitude."
"What is something in your life that gives so much, but is often unnoticed (like electricity)? Reflect on your gratitude for the simple things around us."

3. Waitlist Control Group (WLC).
Intervention code [1] 328372 0
Behaviour
Comparator / control treatment
Waitlist Control Group (WLC). This condition will complete the questionnaires at the same times points as the two intervention groups. They will then receive the TYD Intervention at week 5, once the two intervention groups have completed.
Control group
Active

Outcomes
Primary outcome [1] 337923 0
Anxiety at post-treatment
Timepoint [1] 337923 0
Anxiety will be assessed using the GAD-2 at assessment (baseline, prior to the intervention), mid-treatment (end of the second week of receiving the SMS messages); and at the primary endpoint (Post-treatment, which will be at week 5, one week after the last SMS message). The GAD-2 will also be assessed 3-months after post-treatment (this is the secondary endpoint).
Primary outcome [2] 337924 0
Depression at post-treatment
Timepoint [2] 337924 0
Depression will be assessed using the PHQ-2 at assessment (baseline, prior to the intervention), mid-treatment (end of the second week of receiving the SMS messages); and the primary endpoint (Post-treatment - week 5, one week after the last SMS message). ThePHQ-2 will also be assessed 3-months after post-treatment (this is the secondary endpoint.
Secondary outcome [1] 434265 0
Nil
Timepoint [1] 434265 0
Nil

Eligibility
Key inclusion criteria
(a) Australian resident;
(b) Practicing or training as a healthcare professional;
(c) Experiencing symptoms of depression or anxiety;
(d) 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) Living outside of Australia;
(b) Unable to read and understand English;
(c) Currently receiving psychological treatment;
(d) Self-reported risk of suicide.

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
1/07/2024
Actual
Date of last participant enrolment
Anticipated
30/07/2024
Actual
Date of last data collection
Anticipated
30/11/2024
Actual
Sample size
Target
408
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 316253 0
Other Collaborative groups
Name [1] 316253 0
WA Primary Health Alliance
Country [1] 316253 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Country
Australia
Secondary sponsor category [1] 318442 0
None
Name [1] 318442 0
Address [1] 318442 0
Country [1] 318442 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315073 0
Macquarie University Human Research Ethics Committee Medical Sciences
Ethics committee address [1] 315073 0
Ethics committee country [1] 315073 0
Australia
Date submitted for ethics approval [1] 315073 0
05/04/2024
Approval date [1] 315073 0
30/04/2024
Ethics approval number [1] 315073 0

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

Contacts
Principal investigator
Name 133586 0
Prof Nickolai Titov
Address 133586 0
MindSpot, 2 Technology Place Macquarie University. NSW 2109
Country 133586 0
Australia
Phone 133586 0
+61 2 98509901
Fax 133586 0
Email 133586 0
[email protected]
Contact person for public queries
Name 133587 0
Lauren Staples
Address 133587 0
MindSpot, 2 Technology Place Macquarie University. NSW 2109
Country 133587 0
Australia
Phone 133587 0
+61 2 98509971
Fax 133587 0
Email 133587 0
[email protected]
Contact person for scientific queries
Name 133588 0
Lauren Staples
Address 133588 0
MindSpot, 2 Technology Place Macquarie University. NSW 2109
Country 133588 0
Australia
Phone 133588 0
+61 2 98509971
Fax 133588 0
Email 133588 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?

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.