Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001113549p
Ethics application status
Submitted, not yet approved
Date submitted
26/08/2024
Date registered
16/09/2024
Date last updated
16/09/2024
Date data sharing statement initially provided
16/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of Hello Sunday Morning’s online alcohol behaviour change programs and services for the community
Scientific title
An evaluation of Hello Sunday Morning’s online alcohol behaviour change programs and services for adults in the community
Secondary ID [1] 312811 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol use disorders 334881 0
Risky alcohol use 334882 0
Condition category
Condition code
Mental Health 331433 331433 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will conduct a randomised controlled trial (RCT) of the new online Hello Change program which will be launched in January 2025. Hello Change is an online self-paced interactive program, existing of 6 modules and taking around 2 hours to complete. The Hello Change program focuses on understanding the interactions between thoughts, feelings and behaviours and teaches practical skills for behaviour change in relation to alcohol. It includes modules around understanding their relationship with alcohol, how to make changes, managing craving and urges, managing social situations and relapse prevention.

Potential participants can access the link to the Hello Change program via the Hello Sunday Morning website. Potential participants are asked to read the online copy of the participant information statement and consent form before the Hello Change program can be accessed. Individuals who have provided consent to participate the RCT for the Hello Change program will be randomly assigned to either receiving the Hello Change intervention (completing the online program) or no intervention (waitlist). Participations in the intervention group are expected to complete all six modules within six weeks.

The intervention group will include people who will complete the Hello Change program within 6 weeks. A clinical psychologist is available for participants if they feel distressed throughout the RCT (as detailed in the participant information sheet). Adherence to the intervention is measured by completion of the program.

We will also conduct qualitative interviews (n=20) with people who have accessed the Hello Change program to gain a deeper understanding of the strengths and weaknesses of the program. The interviews will be conducted over the telephone or via Teams and approximately take 45 to 60 minutes.
Intervention code [1] 329351 0
Behaviour
Intervention code [2] 329427 0
Lifestyle
Comparator / control treatment
The control group will include people who will be on the waitlist. The waitlist group will be able to access the program after 6 weeks. The waitlist group will be able to access our Daybreak program while waiting.

Daybreak is a smartphone app that is accessible worldwide via major app stores. The app is supported by the Australian Government and offered free of charge to Australian residents. Daybreak provides support in the form of a peer-led community of individuals seeking to change their relationship with alcohol.
Control group
Active

Outcomes
Primary outcome [1] 339189 0
Alcohol use
Timepoint [1] 339189 0
Baseline, and 6 and 12 weeks post access (both groups). The control group will complete one extra survey at the end of the 6-week waitlist.
Secondary outcome [1] 438988 0
Psychological wellbeing
Timepoint [1] 438988 0
Baseline, and 6 and 12 weeks post access (both groups). The control group will complete one extra survey at the end of the 6-week waitlist.
Secondary outcome [2] 439600 0
Uptake and program completion
Timepoint [2] 439600 0
The number of registrations and program completion will be assessed at the end of the recruitment period.
Secondary outcome [3] 439601 0
Program experience (strengths)
Timepoint [3] 439601 0
At program completion (for those who complete) or six weeks after accessing Hello Change program (for those who do not complete).
Secondary outcome [4] 439723 0
Program experience (weaknesses)
Timepoint [4] 439723 0
At program completion (for those who complete) or six weeks after accessing Hello Change program (for those who do not complete).
Secondary outcome [5] 439724 0
Satisfaction with the program.
Timepoint [5] 439724 0
At program completion (for those who complete) or six weeks after accessing Hello Change program (for those who do not complete).

Eligibility
Key inclusion criteria
The following applies to all our participants registering for any of our programs:
• Individuals (worldwide) aged over 18 registering for one of the Hello Sunday Morning programs will be given access.

Inclusion Criteria:
• Aged 18 or older (a requirement when registering for any Hello Sunday Morning program)
• Registering for one of the Hello Sunday Morning programs
• English language sufficient to comprehend study requirements
• wanting to change their relationship with alcohol

Participants do not have to have to an alcohol use disorder to be able to participate in this study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria:
• Unwilling to provide informed consent
• Not accessing one of the Hello Sunday Morning programs

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Efficacy
Statistical methods / analysis
Basic descriptive statistics will be conducted to describe the study sample. Repeated measures ANOVA will be used to assess score changes on alcohol consumption (AUDIT-C scores), and psychological wellbeing (K6). Statistical analyses will be performed using SPSS.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/03/2026
Actual
Sample size
Target
592
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 317241 0
Charities/Societies/Foundations
Name [1] 317241 0
NIB foundation
Country [1] 317241 0
Australia
Funding source category [2] 317249 0
Charities/Societies/Foundations
Name [2] 317249 0
Ian Potter foundation
Country [2] 317249 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
NIB foundation
Address
Country
Australia
Secondary sponsor category [1] 319522 0
Charities/Societies/Foundations
Name [1] 319522 0
Ian Potter foundation
Address [1] 319522 0
Country [1] 319522 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315979 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 315979 0
Ethics committee country [1] 315979 0
Australia
Date submitted for ethics approval [1] 315979 0
03/09/2024
Approval date [1] 315979 0
Ethics approval number [1] 315979 0

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

Contacts
Principal investigator
Name 136410 0
Dr Katinka van de Ven
Address 136410 0
Hello Sunday Morning, 103 Alexander St, Crows Nest NSW 2065
Country 136410 0
Australia
Phone 136410 0
+61 1300 403 196
Fax 136410 0
Email 136410 0
[email protected]
Contact person for public queries
Name 136411 0
Katinka van de Ven
Address 136411 0
Hello Sunday Morning, 103 Alexander St, Crows Nest NSW 2065
Country 136411 0
Australia
Phone 136411 0
+61 1300 403 196
Fax 136411 0
Email 136411 0
[email protected]
Contact person for scientific queries
Name 136412 0
Katinka van de Ven
Address 136412 0
Hello Sunday Morning, 103 Alexander St, Crows Nest NSW 2065
Country 136412 0
Australia
Phone 136412 0
+61 1300 403 196
Fax 136412 0
Email 136412 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
Not available due to ethical constraints.


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.