Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000027819
Ethics application status
Approved
Date submitted
27/10/2020
Date registered
14/01/2021
Date last updated
14/01/2021
Date data sharing statement initially provided
14/01/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Wellbeing outcomes in Prince of Wales Hospital staff
Scientific title
The impact of the "Thrive" wellbeing program on wellbeing outcomes in POWH hospital staff
Secondary ID [1] 302605 0
None
Universal Trial Number (UTN)
U1111-1260-0754
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wellbeing 319494 0
Condition category
Condition code
Mental Health 317458 317458 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a 12-week trial involving a 7-week intervention with 2 arms and 4 measurement occasions. The trial will recruit staff from Prince of Wales Hospital in Sydney (primarily nurses, but anyone employed at the hospital will be eligible to join), and the aim will be to measure the participants' levels of wellbeing over time and to determine whether the 7-week intervention is effective at increasing their wellbeing.
All participants will complete an online survey in week 0 (i.e. one week before the intervention begins), week 4 (mid-intervention), week 8 (one week post-intervention), and week 12 (four weeks post-intervention). Each participant will be randomly allocated to one of the two arms. The two arms will run simultaneously, from week 1 to week 7, and each arm will comprise around 100 participants.
The intervention arm will involve a 7-week program of weekly one-hour online seminars (webinars). During the 7-week program, the intervention participants will watch each weekly webinar. They will have the option of attending each webinar live (via Zoom) or watching a recording of the webinar later in the week (in their own time). Each webinar will focus on one area of life (e.g. sleep, exercise, nutrition) that is related to wellbeing. Each webinar will provide background scientific information about its area, and then provide suggestions on how to make improvements within the area, with the goal of increasing the participants' wellbeing. Thus, the intervention arm will provide knowledge + solutions.
The webinars will be delivered by two presenters. One is a Nurse Educator with a Master degree in Adult Education and extensive experience in coaching, educating, and training, and the other is a Research Assistant with a Ph.D. in Psychology and extensive experience in tutoring, teaching, lecturing, and counselling.
At each measurement occasion, the participants will complete an online survey measuring their levels of wellbeing, as well as other relevant variables, including depression, anxiety, and stress. The surveys will also ask the participants about their levels of adherence to the program (i.e., which of the webinars they have watched, and whether they watched each webinar partially or in full). Attendance of live webinars will also be recorded via Zoom.
Intervention code [1] 318891 0
Behaviour
Comparator / control treatment
This is a 12-week trial involving a 7-week intervention with 2 arms and 4 measurement occasions. The trial will recruit staff from Prince of Wales Hospital in Sydney (primarily nurses, but anyone employed at the hospital will be eligible to join), and the aim will be to measure the participants' levels of wellbeing over time and to determine whether the 7-week intervention is effective at increasing their wellbeing.
All participants will complete an online survey in week 0 (i.e. one week before the intervention begins), week 4 (mid-intervention), week 8 (one week post-intervention), and week 12 (four weeks post-intervention). Each participant will be randomly allocated to one of the two arms. The two arms will run simultaneously, from week 1 to week 7, and each arm will comprise around 100 participants.
The control arm will involve a 7-week program of weekly readings, in the form of digital pamphlets emailed to the control participants. During the 7-week program, the control participants will read each weekly pamphlet. Each pamphlet will focus on one area of life (e.g. sleep, exercise, nutrition) that is related to wellbeing. Each pamphlet will provide background scientific information about its area, but it will not provide suggestions on how to make improvements within the area. Thus, the control arm will provide knowledge only, without solutions.
The pamphlets will be created by two members of the research team. One is a Nurse Educator with a Master degree in Adult Education and extensive experience in coaching, educating, and training, and the other is a Research Assistant with a Ph.D. in Psychology and extensive experience in tutoring, teaching, lecturing, and counselling.
At each measurement occasion, the participants will complete an online survey measuring their levels of wellbeing, as well as other relevant variables, including depression, anxiety, and stress. The surveys will also ask the participants about their levels of adherence to the program (i.e., which of the pamphlets they have read, and whether they read each pamphlet partially or in full).
Control group
Active

Outcomes
Primary outcome [1] 325490 0
Wellbeing, as measured by the COMPAS-W questionnaire (Gatt et al., 2014).
Timepoint [1] 325490 0
Week 0 (one week before intervention begins)
Week 4 (mid-intervention)
Week 8 (one week after intervention completion) - this is the primary endpoint
Week 12 (four weeks after intervention completion)
Primary outcome [2] 325518 0
Psychological distress, as measured by the DASS-21 questionnaire (Lovibond & Lovibond, 1995).
Timepoint [2] 325518 0
Week 0 (one week before intervention begins)
Week 4 (mid-intervention)
Week 8 (one week after intervention completion) - this is the primary endpoint
Week 12 (four weeks after intervention completion)
Secondary outcome [1] 388132 0
Health and lifestyle habits, as measured by the Health and Lifestyle Questionnaire.
Timepoint [1] 388132 0
Week 0 (one week before intervention begins)
Week 4 (mid-intervention)
Week 8 (one week after intervention completion)
Week 12 (four weeks after intervention completion)
Secondary outcome [2] 388133 0
Self-compassion, as measured by the S-CS questionnaire (Neff et al., 2003).
Timepoint [2] 388133 0
Week 0 (one week before intervention begins)
Week 4 (mid-intervention)
Week 8 (one week after intervention completion)
Week 12 (four weeks after intervention completion)
Secondary outcome [3] 388276 0
Compassion for others, as measured by the CS questionnaire (Pommier et al., 2019).
Timepoint [3] 388276 0
Week 0 (one week before intervention begins)
Week 4 (mid-intervention)
Week 8 (one week after intervention completion)
Week 12 (four weeks after intervention completion)
Secondary outcome [4] 388277 0
Mindfulness, as measured by the MAAS questionniare (Brown & Ryan, 2003; Carlson & Brown, 2005).
Timepoint [4] 388277 0
Week 0 (one week before intervention begins)
Week 4 (mid-intervention)
Week 8 (one week after intervention completion)
Week 12 (four weeks after intervention completion)
Secondary outcome [5] 388278 0
Work performance, as measured by the HPQ questionnaire (Kessler et al., 2003).
Timepoint [5] 388278 0
Week 0 (one week before intervention begins)
Week 4 (mid-intervention)
Week 8 (one week after intervention completion)
Week 12 (four weeks after intervention completion)
Secondary outcome [6] 388279 0
Work engagement, as measured by UWES questionnaire (Seppala et al., 2009).
Timepoint [6] 388279 0
Week 0 (one week before intervention begins)
Week 4 (mid-intervention)
Week 8 (one week after intervention completion)
Week 12 (four weeks after intervention completion)

Eligibility
Key inclusion criteria
Currently employed at Prince of Wales Hospital, Sydney.
Willing to spend up to an hour a week (for 7 consecutive weeks) on a webinar/pamphlet.
Able to communicate in spoken and written English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
N/A

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Prospective participants will apply to participate in the trial via a website. The list of applicants will be numbered and a random number generator will be used to allocate them to either of the two arms.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation via statistical software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The participants will be aware of whether they have been allocated to the online version or the take-home pamphlet version of the wellbeing program. However, they will not know that the pamphlet version will be serving as the control group. Therefore, both groups will presumably believe that they are receiving a complete program.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power calculations suggest a minimum of 100 participants in each of the two groups over the 4 time points to have the sample size to detect small effects at 80% power. This sample size was calculated using the statistical software package G*Power (ver. 3.1.9.2). As Cohen and Cohen (1975) have pointed out, correlations in the social and behavioural sciences rarely exceed +/-0.5, with a standardized regression coefficient of +/-0.1 representing a small effect, +/-0.3 a moderate effect, and +/-0.5 a large effect. Assuming a small-to-moderate effect of +/-0.2 (corresponding to a partial eta-squared of 0.04), a conventional type-1 error rate of 0.05, and a correlation of 0.5 among the repeated outcome measures, the study design will be able to detect such an effect at 80% power with 60 participants in each group. However, taking into account an attrition rate of up to 40% (based on previous studies), it will be necessary to recruit at least 100 people per group. Assuming a more favourable attrition rate of 20%, having 100 people per group will allow detection of even smaller effects (as small as partial eta-squared = 0.03).
The data will be analysed via an Analysis of Covariance (ANCOVA) whereby the linear relationship between time and wellbeing will be calculated for each of the two arms, and the relationships will be compared to determine whether there is a significant difference between the arms in terms of how the participants' levels of wellbeing (and other primary and secondary outcomes) change over time. This analysis will also allow the inclusion of statistical control variables. Thus, it will allow the researchers to determine whether any difference between the two arms is dependent on the value of a third variable, such as resilience.

Reference: Cohen, J. & Cohen, P. (1975). Applied Multiple Regression/Correlation Analysis for the Behavioral Sciences. Hillsdale, NJ: Lawrence Erlbaum.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2021
Actual
Date of last participant enrolment
Anticipated
5/02/2021
Actual
Date of last data collection
Anticipated
23/04/2021
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 17875 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 31732 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 307034 0
Other Collaborative groups
Name [1] 307034 0
Mindgardens Neuroscience Network
Country [1] 307034 0
Australia
Primary sponsor type
Individual
Name
Dr Justine M. Gatt
Address
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street, Randwick, NSW 2031
Australia
Country
Australia
Secondary sponsor category [1] 307641 0
None
Name [1] 307641 0
Address [1] 307641 0
Country [1] 307641 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307164 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 307164 0
District Executive Unit, Level 4
The Sutherland Hospital & Community Health Service
Cnr The Kingsway & Kareena Road
Caringbah, NSW 2229
Ethics committee country [1] 307164 0
Australia
Date submitted for ethics approval [1] 307164 0
25/08/2020
Approval date [1] 307164 0
09/11/2020
Ethics approval number [1] 307164 0

Summary
Brief summary
This is a 12-week trial involving a 7-week wellbeing program. The trial will recruit staff from Prince of Wales Hospital in Sydney (primarily nurses, but anyone employed at the hospital will be eligible to join), and the aim will be to measure the participants' levels of wellbeing over time and to determine whether the 7-week program is effective at increasing their wellbeing, compared to an alternative program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106254 0
Dr Justine M. Gatt
Address 106254 0
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street, Randwick, NSW 2031
Country 106254 0
Australia
Phone 106254 0
+61 2 9399 1812
Fax 106254 0
Email 106254 0
j.gatt@neura.edu.au
Contact person for public queries
Name 106255 0
Dr Luke A. Egan
Address 106255 0
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street, Randwick, NSW 2031
Country 106255 0
Australia
Phone 106255 0
+61 2 9399 1883
Fax 106255 0
Email 106255 0
l.egan@neura.edu.au
Contact person for scientific queries
Name 106256 0
Dr Luke A. Egan
Address 106256 0
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street, Randwick, NSW 2031
Country 106256 0
Australia
Phone 106256 0
+61 2 9399 1883
Fax 106256 0
Email 106256 0
l.egan@neura.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?

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.