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Trial registered on ANZCTR


Registration number
ACTRN12618001188224p
Ethics application status
Submitted, not yet approved
Date submitted
6/07/2018
Date registered
17/07/2018
Date last updated
23/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving mental health and resilience in older adults
Scientific title
Examining the role of self-reflective resilience training in enhancing resilience in older adults
Secondary ID [1] 295432 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 308681 0
Anxiety 308682 0
Coping efficacy 308683 0
Perceived stress 308684 0
Perceived resilience 308685 0
Condition category
Condition code
Mental Health 307611 307611 0 0
Depression
Mental Health 307612 307612 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Self-Reflection Resilience Training (SRRT) is based on recent research at Macquarie University that demonstrates that an individual’s unique experiences of stress and adversity can be reflected on in order to strengthen personal resilience.

Our intervention program contains two 40 minute, targeted, face-to-face workshops that provide participants with an opportunity to consider their personal aspirations for successful aging and their current capabilities to meet those aspirations. These face-to-face sessions are administered by the primary researcher and research assistant in sessions limited to 30 per group, and involve discussion/lectures to highlight the role that adversity and stress can play in strengthening resilience and learning to reflect on adversity as an opportunity for personal development.

The first session aims to set the scene for the use of self-reflection for the purpose of resilience training, and the second occurs five weeks after the initial session to reinforce how self-reflection can be used to develop the participants’ personalised model of resilience and marks the completion of the intervention.

Structured reflective journaling, and two 20 minute individual telephone coaching sessions, occur between the training sessions, and are used to help participants consider their own challenging life experiences, their personal repertoire of coping strengths, and identify areas of vulnerability. Structured reflective journaling is conducted with a provided workbook, once a week for the five weeks between training sessions, by the participant. Individual telephone coaching occurs 2 and 4 weeks after the initial training program, delivered by coaches trained in the systematic self-reflective coaching protocol. The coaching monitors adherence to workbook completion and encourages training engagement, but also emphasises assisting the coachee to develop self-awareness (i.e., personal concerns of participants in relation to late careers), evaluate their coping and emotion regulatory responses, and opportunities for self-development (i.e., facilitating the emergence of personalised coping strategies) via a coaching paradigm, reflection is encouraged on one's coping and emotion regulation with a view to evaluating it's efficacy on the bases of personal values and value-based goals. A personalised model of resilience is intended to emerge via this iterative process of reflection and refinement of one's coping and emotion regulatory repertoire.

By highlighting the participant’s personal strengths, limitations and aspirations for successful ageing we support the participant in developing a plan for good mental and physical health. This plan may involve engagement in programs that promote active living, activities that reduce social isolation (e.g., volunteering) and continued employment or job seeking. The end-goal is reductions in depression, anxiety, and chronic stress among program participants compared to the control groups.

This study will utilise a longitudinal group-randomised controlled trial to assess the efficacy of Self-Reflective Resilience Training (SRRT; intervention) over a Non-Directive Support Group (NDSG; active control) for both working and non-working older adults (50+ years). In two parallel programs, we will recruit working and non-working older adults to participate in either an SSRT (intervention) or a NDSG (active control) training program. Participants will be surveyed at three time points: (1) baseline-prior to training, (2) immediately after the completion of training, (3) three-month follow-up.

Hair samples for cortisol analysis will also be taken at three-month follow-up from all participants consenting to hair collection. Assignment to one of the two conditions (SRRT or NDSG programs) will be randomised by group across working and community (retired/job-seeking) groups based on which sessions people are able to attend. Sessions will be assigned to either a control or intervention condition.

Our methodology is intended to examine whether the Self-Reflective Resilience Training (intervention) is superior to a standard Non-Directive Support Group (active control) program. A randomised controlled trial is the most rigorous test of the efficacy and longer-term benefits of the SRRT program for both working and non-working older adults, compared to an active control to control for non-specific treatment effects (e.g., contact with a psychologist). The longitudinal design will allow us to explore outcomes while controlling for baseline functioning.
Intervention code [1] 301739 0
Treatment: Other
Intervention code [2] 301881 0
Prevention
Comparator / control treatment
Participants in the control condition will join a Non-Directive Support Group (NDSG) rather than SRRT. Like the SRRT group, participants will attend two 40 minute face-to-face sessions that are five weeks apart, limited to 30 per group, and delivered by the primary researcher and research assistant.

The NDSG is intended to normalise experiences and concerns of older Australians and elicit information about awareness of resources, through open discussion. This promotes an environment of social learning where participants can share their concerns, experiences, and solutions.

Between the face-to-face sessions there will also be two 20 minute individual telephone coaching sessions, at 2 and 4 weeks after the initial session. These are delivered by trained coaches to continue the discussion from the face-to-face session. The first call focusing on further concerns, experiences and solutions regarding late career, retirement and aging, and the second exploring opportunities for change that are external to the person (e.g., 'What can the Government, Australian community, or employer do to support older Australians?', 'What resources might assist you to feel supported?"). The information from these responses will also be compiled into a report about the major concerns of older Australians and their recommendations regarding resources and services.

The second face-to-face session will conclude with a short reflection on the challenges raised and ideas for resources and services. Participants will be surveyed at three timepoints: (1) baseline-prior to training, (2) immediately after the completion of training, (3) three-month follow-up. Hair samples for cortisol analysis will also be taken at three-month follow-up from all participants consenting to hair collection.
Control group
Active

Outcomes
Primary outcome [1] 306613 0
Anxiety. The Generalized Anxiety Disorder 7-Item (GAD-7) Questionnaire contains 7-items designed to measure symptoms of anxiety and anxiety severity. The GAD-7 has been demonstrated to have good psychometric properties (Lowe, et al., 2008).
Timepoint [1] 306613 0
There are three time points: baseline, at the end of the intervention or active control training (initial follow-up) and at 3-month follow-up. The three-month follow-up from cessation of intervention or active control training is our primary time point of interest.
Primary outcome [2] 306614 0
Depression. The Patient Health Questionnaire – 9 items (PHQ-9) will be used to examine the presence of current depression symptoms and their severity in participants at all three time points (Kroenke, et al., 2009 ).
Timepoint [2] 306614 0
There are three time points: baseline, at the end of the intervention or active control training (initial follow-up) and at 3-month follow-up. The three-month follow-up from cessation of intervention or active control training is our primary time point of interest.
Primary outcome [3] 306615 0
Perceived resilience. The Brief Resilience Scale will be used assess participants' resilience at all three time points (Smith, Dalen, Wiggins, Tooley, Christopher, & Bernard, 2008).
Timepoint [3] 306615 0
There are three time points: baseline, at the end of the intervention or active control training (initial follow-up) and at 3-month follow-up. The three-month follow-up from cessation of intervention or active control training is our primary time point of interest.
Secondary outcome [1] 349015 0
Chronic stress from hair cortisol. Scalp hair samples will be collected and analysed to provide a measure of stress experience over a 3-month period.
Timepoint [1] 349015 0
The hair samples will be collected at the 3-month follow-up from cessation of intervention or active control training, with the primary outcomes. This is listed as a secondary outcome as a differing variable of secondary interest, not due to a difference in timepoint from the primary outcome.
Secondary outcome [2] 349016 0
Coping self-efficacy. Coping self-efficacy (CSE; Chesney, Chambers, Taylor, Johnson, & Folkman, 2003),
Timepoint [2] 349016 0
Coping self-efficacy will be assessed at the 3-month follow-up from cessation of intervention or active control training, with the primary outcomes. This is listed as a secondary outcome as a differing variable of secondary interest, not due to a difference in timepoint from the primary outcome.
Secondary outcome [3] 349017 0
Perceived stress. The perceived Stress Scale (PSS: Cohen, Kamarck, & Mermelstein, 1983) is a classic stress assessment instrument.
Timepoint [3] 349017 0
Perceived stress will be assessed at the 3-month follow-up from cessation of intervention or active control training, with the primary outcomes. This is listed as a secondary outcome as a differing variable of secondary interest, not due to a difference in timepoint from the primary outcome.

Eligibility
Key inclusion criteria
Working and non-working adults 50 years of age or over.
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Those who report a current mental health or memory-related diagnosis

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
We conducted a longitudinal power analysis using R based on a group-RCT conducted in a military sample. The power analysis indicated that at a minimum of 80 participants per group at the final time point was required to detect a difference of 20% between the SRRT and NDSG based on a moderate effect size and alpha significance level of 0.05.

To address missing values data, replacement values will be generated for all dependent variables following an analysis of missing values assumptions (Little, et al., 2012).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC

Funding & Sponsors
Funding source category [1] 300018 0
Government body
Name [1] 300018 0
NSW Department of Family and Community Services
Address [1] 300018 0
FACS Head Office
Locked Bag 10, Strawberry Hills NSW 2012
Country [1] 300018 0
Australia
Funding source category [2] 300019 0
University
Name [2] 300019 0
Macquarie University
Address [2] 300019 0
Macquarie University
North Ryde NSW 2109
Country [2] 300019 0
Australia
Funding source category [3] 300027 0
Commercial sector/Industry
Name [3] 300027 0
Coca-Cola Amatil
Address [3] 300027 0
Coca-Cola Amatil Offices
40 Mount St, North Sydney NSW 2060
Country [3] 300027 0
Australia
Primary sponsor type
Government body
Name
NSW Department of Family and Community Services
Address
FACS Head Office
Locked Bag 10, Strawberry Hills NSW 2012
Country
Australia
Secondary sponsor category [1] 299406 0
University
Name [1] 299406 0
Macquarie University
Address [1] 299406 0
Macquarie University
North Ryde NSW 2109
Country [1] 299406 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 300871 0
Macquarie University Human Research Ethics Committee Medical Sciences [EC00448]
Ethics committee address [1] 300871 0
Macquarie University Human Research Ethics Committee Medical Sciences [EC00448]
Macquarie University
North Ryde NSW 2109
Ethics committee country [1] 300871 0
Australia
Date submitted for ethics approval [1] 300871 0
06/07/2018
Approval date [1] 300871 0
Ethics approval number [1] 300871 0

Summary
Brief summary
This project will deliver innovative resilience training for older Australians (50+ years). Fifty years of age reflects a point of major work and life transition (National Seniors Australia) and we seek to assist adjustment at this critical life-stage. According to Beyond Blue and government reports, incidences of depression and stress are reported by 10-15% of the population over 50 years of age (Commonwealth Department of Health), with physical and psychological illness ranked the 2nd most common reason for people leaving the workforce prematurely (ABS, 2017). Our project is designed to mitigate these effects by improving psychological resilience among older Australians to keep them in the workforce longer, and to improve psychological outcomes and enhance community engagement among older unemployed Australians.

Unlike conventional resilience training that takes a ‘one size fits all’ approach, we have developed a personalised self-reflection strategy to building resilience. This strategy enables participants to identify and build on their individual strengths, and to harness these in the face of challenges.

Leveraging our success in fostering resilience in the Australian military, we will tailor our unique approach for older Australians and test its efficacy with two key groups; working and unemployed and retired older adults. This will be the first resilience training tailored to older adults with the objective of preventing mental illness and developing the skills and insights needed to cope with the inevitable adjustments and challenges of ageing. In collaboration with a major national employer and local councils, we will deliver a new tool to support older Australians to lead active and fulfilling lives, while reducing the risk of mental illness that affects Australians over 50.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85106 0
Dr Monique Crane
Address 85106 0
Building C3A, Department of Psychology
Macquarie University, North Ryde, NSW, 2109
Country 85106 0
Australia
Phone 85106 0
+61 2 9850 8604
Fax 85106 0
Email 85106 0
monique.crane@mq.edu.au
Contact person for public queries
Name 85107 0
Miss Madison Kho
Address 85107 0
Building C3A, Department of Psychology
Macquarie University, North Ryde, NSW, 2109
Country 85107 0
Australia
Phone 85107 0
+61 2 9850 8604
Fax 85107 0
Email 85107 0
madison.kho@mq.edu.au
Contact person for scientific queries
Name 85108 0
Dr Monique Crane
Address 85108 0
Building C3A, Department of Psychology
Macquarie University, North Ryde, NSW, 2109
Country 85108 0
Australia
Phone 85108 0
+61 2 9850 8604
Fax 85108 0
Email 85108 0
monique.crane@mq.edu.au

No information has been provided regarding IPD availability
Summary results
No Results