Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001052921
Ethics application status
Approved
Date submitted
17/06/2020
Date registered
15/10/2020
Date last updated
8/03/2024
Date data sharing statement initially provided
15/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Promoting Resilience in Nurses: evaluating the impacts of a workplace resilience program on mental health nurse wellbeing
Scientific title
Promoting Resilience in Nurses: evaluating the impacts of a workplace resilience program on mental health nurse wellbeing
Secondary ID [1] 301553 0
None
Universal Trial Number (UTN)
Trial acronym
PRiN RCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health Nurses’ workplace stress 317920 0
Mental Health Nurses' psychological wellbeing 318490 0
Condition category
Condition code
Mental Health 315955 315955 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Promoting Resilience in Nurses (PRiN) program is an applied and sustainable workplace prevention programme which aims to build individual resilience in the context of adversity and stress, increase mental health and wellbeing, and improve coping self-efficacy and interpersonal communication strategies. The program is strengths-based and incorporates the evidence-base of cognitive behavioural and interpersonal approaches with posttraumatic growth theory.

The PRiN program has been tailored for mental health nursing, including program content, activities and audio-visual clips relevant to this specialty nursing field. The program is delivered by accredited trained facilitators (in this case, experienced mental health nurses) face-to-face in a peer-group setting in 2 x 6 hour workshops spread three weeks apart. A workshop attendance checklist is kept for each program. The program is multimodal and manualized, employing a range of teaching modalities including workbooks, PowerPoint, group discussion (large and small) and individual activities. ‘Booster’ activities (1 per week) reinforcing particular resilience strategies in the program are sent by SMS to participants in between the two workshop days, with provision of weekly activities for each of three weeks following completion of the final workshop. Booster activities take ~10 minutes. An example is to remind participants to use thought challenges to change negative self-talk.

Topics covered in the 6 program modules are: identifying strengths and understanding resilience; understanding and managing stress; challenging and changing negative self-talk; drawing strength from adversity; promoting positive relationships and managing conflict; and creating solutions for well-being.
Intervention code [1] 317853 0
Prevention
Intervention code [2] 318551 0
Behaviour
Comparator / control treatment
Participants in the control group will be offered the intervention at the end of the data collection period. They will complete measures at the same time as the intervention group at the T1, T2 and T3 data collection points. Participants in the control group will have the opportunity to participate in the program following the completion of the data collection period.
Control group
Active

Outcomes
Primary outcome [1] 324163 0
Coping Self-Efficacy
Timepoint [1] 324163 0
Self-report questionnaire data on coping self-efficacy will be collected using the Coping Self-efficacy Scale (Short) from both the intervention and control groups on entry to the study (T1), immediately after program delivery (T2) and 3 months after the program (T3) (primary endpoint).
Secondary outcome [1] 383890 0
Emotional self-regulation
Timepoint [1] 383890 0
Self-report questionnaire data on emotional self-regulation will be collected using the Genos Emotional Intelligence Inventory (Short) from both the intervention and control groups on entry to the study (T1), immediately after program delivery (T2) and 3 months after the program (T3).
Secondary outcome [2] 383891 0
Psychological wellbeing
Timepoint [2] 383891 0
Self-report questionnaire data on psychological wellbeing will be collected using the Mental Health Continuum Short-form from both the intervention and control groups on entry to the study (T1), immediately after program delivery (T2) and 3 months after the program (T3).
Secondary outcome [3] 383892 0
Mental health
Timepoint [3] 383892 0
Self-report questionnaire data on mental health will be collected using the Kessler Psychological Distress Scale from both the intervention and control groups on entry to the study (T1), immediately after program delivery (T2) and 3 months after the program (T3).
Secondary outcome [4] 385257 0
Organisational belonging
Timepoint [4] 385257 0
Self-report questionnaire data on organisational belonging will be collected using items from the Psychological Sense of Organisational Membership Scale from both the intervention and control groups on entry to the study (T1), immediately after program delivery (T2) and 3 months after the program (T3).
Secondary outcome [5] 385295 0
Post-Traumatic Growth
Timepoint [5] 385295 0
Self-report questionnaire data on post-traumatic growth will be collected using the Posttraumatic Growth Inventory (21) from both the intervention and control groups on entry to the study (T1), immediately after program delivery (T2) and 3 months after the program (T3).
Secondary outcome [6] 385296 0
Turnover intention
Timepoint [6] 385296 0
Self-report questionnaire data on turnover intention will be collected using the Turnover Intention Scale from both the intervention and control groups on entry to the study (T1), immediately after program delivery (T2) and 3 months after the program (T3).
Secondary outcome [7] 387873 0
Resilience
Timepoint [7] 387873 0
Self-report questionnaire data on resilience will be collected using the Brief Resilience Scale from both the intervention and control groups on entry to the study (T1), immediately after program delivery (T2) and 3 months after the program (T3).

Eligibility
Key inclusion criteria
Registered Nurses and Enrolled Nurses currently employed at NorthWestern Mental Health, Victoria Australia working at least 0.6 Full-Time Equivalent. An 0.6 Full-Time Equivalent or above allows for managers to release staff from shifts to attend the program.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nurses who have participated in previous delivery of the resilience program at NorthWestern Mental Health will not be eligible for this study.

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)
Participants are situated in area units and teams within 6 area health services which comprise NorthWestern Mental Health: a total of 9 inpatient units and 19 community teams. A particular area health service (and its units and teams) will be targeted at a time for recruitment.

Prospective nurse participants will be identified through their team/unit managers, who will send an email invite to all eligible prospective participants. Interested nurses will be able to read the participant information and click on the online REDCap survey link to complete the eligibility survey. If they are eligible, they will then be asked to register their contact details and complete the T1 survey measures. On completion of the T1 survey, they will be informed that a member of the research team will contact them to confirm their allocation to the intervention or control group.

Once ~thirty eligible nurses from an area health service have completed the T1 survey at a time, the project manager will stratify them according to their area health service unit or team, and then randomly allocate them to either the intervention or control group using an automated computer-generated randomization function in REDCap. The investigators will be blinded to group allocation. Participants and the project manager will not be blinded to group allocations.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The block sequence will be developed by computer generation of random number sequences via R by the project manager prior to commencing the project, and maintained by the project manager.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
To determine the effects of the PRiN program on the outcome measures, a partially clustered randomized controlled trial will be conducted. The clustering, in the program arm only, recognizes that the program is delivered by particular facilitators each time, and that this is a significant influence on participant outcomes. Based on the team’s prior experience, the design also allows for workforce needs in relation to release of staff from units and teams.

A mixed methods approach to the parallel process evaluation will provide quantitative and qualitative data that will build comprehensive understandings as to why the program did or didn’t work in terms of participant outcomes. These complementary forms of data will allow for descriptive statistics on program satisfaction and program fidelity, and qualitative themes on barriers and facilitators to program implementation.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A partially clustered design needs special consideration for sample size and power. Within-arm standard deviations of 40 (program) and 36 (control) were used (based on the Coping Self-Efficacy 26 item measure used in the preceding pilot), and a difference in means of 16 units (Cohen’s effect size ˜ 0.42) was taken for the minimum difference of interest. With 12 per group in the program arm, 12 groups gives a sample size of 144 in the program arm; 144 was also used as the sample size in the control arm. Assuming an intraclass correlation of 0.1, alpha = 0.05 and a two-tailed test, the power is 80%. The design allows for participant attrition of up to 20% aiming for 12 groups of 15 in the program arm, 180 in the control arm. Withdrawn participants will not be replaced in the study. Based on our previous experience, the sample size has factored in anticipated attrition of 20%, hence attrition should not impact on the power of the study.

Citation = Foster, K., Shochet, I., Wurfl, A., Roche, M., Maybery, D., Shakespeare-Finch, J., & Furness, T. (2018). On PAR: A feasibility study of the Promoting Adult Resilience programme with mental health nurses. Int J Ment Health Nurs, 27(5), 1470-1480. https://doi.org/10.1111/inm.12447 (There is no registration number for the pilot study).

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Trial recruitment and intervention delivery periods were reduced due to the extenuating circumstances of COVID-19 and limits in the funding timeframe. Investigators adhered to State Government, health services and human ethics committee policies and directives (e.g., lockdowns), resulting in a delay in commencing trial recruitment and intervention delivery, and having to cease recruitment activities for 13 weeks and intervention delivery for a total of 28 weeks during lockdowns.
Date of first participant enrolment
Anticipated
1/11/2020
Actual
4/02/2021
Date of last participant enrolment
Anticipated
30/12/2021
Actual
19/03/2022
Date of last data collection
Anticipated
30/03/2022
Actual
31/08/2022
Sample size
Target
360
Accrual to date
Final
144
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 305987 0
Government body
Name [1] 305987 0
Australian Research Council
Country [1] 305987 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
Australian Catholic University
Level 16, Tenison Woods House, 8-20 Napier Street, North Sydney NSW 2060
Country
Australia
Secondary sponsor category [1] 306448 0
None
Name [1] 306448 0
Address [1] 306448 0
Country [1] 306448 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306226 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 306226 0
Ethics committee country [1] 306226 0
Australia
Date submitted for ethics approval [1] 306226 0
Approval date [1] 306226 0
01/04/2020
Ethics approval number [1] 306226 0
HREC/56912/MH-2020

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

Contacts
Principal investigator
Name 103162 0
Prof Kim Foster
Address 103162 0
Australian Catholic University
Level 5, 215 Spring St.,
Melbourne
3000 VIC
Country 103162 0
Australia
Phone 103162 0
+61 418415259
Fax 103162 0
Email 103162 0
[email protected]
Contact person for public queries
Name 103163 0
Kim Foster
Address 103163 0
Australian Catholic University
Level 5, 215 Spring St.,
Melbourne
3000 VIC
Country 103163 0
Australia
Phone 103163 0
+61 418415259
Fax 103163 0
Email 103163 0
[email protected]
Contact person for scientific queries
Name 103164 0
Kim Foster
Address 103164 0
Australian Catholic University
Level 5, 215 Spring St.,
Melbourne
3000 VIC
Country 103164 0
Australia
Phone 103164 0
+61 418415259
Fax 103164 0
Email 103164 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
IPD not shared to safeguard participant privacy. All publications from the research will be openly accessible.


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.