Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12622000689774p
Ethics application status
Submitted, not yet approved
Date submitted
8/04/2022
Date registered
12/05/2022
Date last updated
12/05/2022
Date data sharing statement initially provided
12/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Facilitating wellbeing behaviours: An online workshop for young adults aged 18-30
Scientific title
Facilitating meaning in life and the factors that make it: Exploring the efficacy of a two week online intervention for young adults aged 18-30
Secondary ID [1] 306532 0
None
Universal Trial Number (UTN)
NA
Trial acronym
NA
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Depression 325416 0
Psychological wellbeing 325417 0
Condition category
Condition code
Mental Health 322807 322807 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be invited to participate in a 2-week online intervention, focused on facilitating the search for meaning in young people’s lives. Carried out over the course of 2 online sessions, completed once per week for 2 weeks, participants will firstly be required to read through an explanatory statement outlining the procedure and requirements of the intervention, and then sign a consent form indicating their consent and intention to participate in the study.

Participants will be recruited up to two weeks prior to the interventions start date. To be enrolled in this study they must complete the baseline questionnaire, a 15-minute survey seeking information on participants self-perceived meaning in life, hope, resilience and wellbeing (as measured by the below scales). All participants will be enrolled simultaneously to Group A: (hedonistic group), Group B (eudaimonic group) or Group C (control group) using a random allocation schedule (conducted by an independent third party) using random block sizes of 2 and 4.

Upon completion of this baseline survey, participants will receive a unique completion code that they will then email back to the chief examiner, and they will then be randomly allocated to one of three groups, group A, group B or group C. Once allocated to a group, participants will then be sent their first intervention activity (either group A week 1 activity or group B week 1 activity. Group C will be asked to continue life as normal and to fill out the questionnaires as needed)). Participants in both of the intervention groups will then have 7 days to read through and complete their allocated activity, and then email their responses back to the chief investigator. The activity provided for the hedonistic group (group a) will include the completion of a mindfulness mediation exercise, while the activity for the eudaimonic group (group b) includes participants responding to a series of promptings asking them to reflect on what gives their life meaning, and then writing a letter from their supposed 90-year-old self to their present-day self with thoughts around what they would tell themselves to stop/start/continue doing to help create a more meaningful life?
The time required for participants in either group to complete this first activity in both groups should be around 30 minutes.

After this 7 day period, participants will be sent a reminder to complete and submit their first week’s activities, will then all receive their second round of reading and activities. Participants who do not complete their first weeks activities will still be sent their second activity. As with week one, participants will have 7 days to complete this task, and submit it back to the chief investigator via email. The time required to do so for them should again be around 30 minutes. The second activity provided for the hedonistic group (group a) will include them engaging in an activity that brings them pleasure, such as savouring a delicious meal and submitting a 100 word documentation on this experience, including how it made them feel; while the activity for the eudaimonic group (group b) ask them to engage in a helping behaviour, including volunteering their time to help someone else, share some money with a person in need or a charity, or commit some time to a local community group, while also submitting a 100 word documentation on this experience, including how it made them feel.

Participants in all groups will receive a link for their second and final survey. They will have 10 days to complete this final survey, at day 10 all those who have not finished this will be contacted and given an additional 4 days (14 days total). Those who do not complete this following your prompt will be considered to have dropped out. Again, they will receive a completion code upon completing this, and once they submit this code, they will receive a debrief statement and information on being reimbursed for their time.
Participants will be remunerated with $10 if they complete the pretest and posttest measures. Participants will be given $20 if, in addition to completing these measures, they also send back the two required weekly emails. This will be paid in the form of gift cards.
Intervention code [1] 322960 0
Behaviour
Comparator / control treatment
The control group will receive no treatment.
Control group
Active

Outcomes
Primary outcome [1] 330592 0
Any change in wellbeing scores as measured using the Center for Epidemiological Studies Depression Scale (CESD; Lewinsohn et al., 1997).
Timepoint [1] 330592 0
2 weeks post-intervention commencement
Secondary outcome [1] 406858 0
Any change in life meaning scores as measured using the Meaning in Life Questionnaire (MLQ, Steger et al., 2006).
Timepoint [1] 406858 0
2 weeks post-intervention commencement

Eligibility
Key inclusion criteria
Participants must be english speaking, and aged between 18 and 30 years.
Minimum age
18 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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)
Permuted block randomisation using a random allocation schedule (conducted by an independent third party) using random block sizes of 3 and 6.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
All hypotheses will be assessed using a one-factor between-groups ANCOVA on the posttest scores using the pretest score as a covariate. This will be followed up with three pairwise contrasts: Group A vs CON, Group B vs CON, Group A vs B. Missing data will be imputed using multiple imputation. The primary analysis will follow intention-to-treat protocol (all those randomized to group will remain part of that group in the analysis regardless of dropout or non-adherence). A secondary per-protocol analysis will be performed including only participants with complete pretest and posttest data and only those that adhered fully to the intervention.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2022
Actual
Date of last participant enrolment
Anticipated
20/06/2022
Actual
Date of last data collection
Anticipated
1/08/2022
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 310874 0
University
Name [1] 310874 0
Federation University
Country [1] 310874 0
Australia
Primary sponsor type
University
Name
Federation University
Address
Federation University Australia, Mount Helen Campus, PO Box 663 Ballarat VIC 3353
Country
Australia
Secondary sponsor category [1] 312138 0
None
Name [1] 312138 0
Address [1] 312138 0
Country [1] 312138 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310435 0
Federation University HREC
Ethics committee address [1] 310435 0
Ethics committee country [1] 310435 0
Australia
Date submitted for ethics approval [1] 310435 0
14/04/2022
Approval date [1] 310435 0
Ethics approval number [1] 310435 0

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

Contacts
Principal investigator
Name 117658 0
Dr Ashley Humphrey
Address 117658 0
Federation University Australia, Mount Helen Campus, PO Box 663 Ballarat VIC, 3353.
Country 117658 0
Australia
Phone 117658 0
+61 421500382
Fax 117658 0
Email 117658 0
[email protected]
Contact person for public queries
Name 117659 0
Ashley Humphrey
Address 117659 0
Federation University Australia, Mount Helen Campus, PO Box 663 Ballarat VIC, 3353.
Country 117659 0
Australia
Phone 117659 0
+61 421500382
Fax 117659 0
Email 117659 0
[email protected]
Contact person for scientific queries
Name 117660 0
Ashley Humphrey
Address 117660 0
Federation University Australia, Mount Helen Campus, PO Box 663 Ballarat VIC, 3353.
Country 117660 0
Australia
Phone 117660 0
+61 421500382
Fax 117660 0
Email 117660 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial will be shared in the form of de-identified SPSS files, as well as online in a de-identified form as part of the Open Sciences Project.
When will data be available (start and end dates)?
Data will be available from the time of completion of data analysis until 5 years after publication
Available to whom?
General public.
Available for what types of analyses?
All statstical tests.
How or where can data be obtained?
Data will be made available by emailing the principal investigator ([email protected])


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.