Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001188224
Ethics application status
Approved
Date submitted
6/07/2018
Date registered
17/07/2018
Date last updated
3/09/2019
Date data sharing statement initially provided
3/09/2019
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
The study involved a partial group RCT design with three conditions: (1) corporate active control condition, (2) corporate SRT group, and (3) community SRT group.

Corporate participants were allocated to the training or control condition between September and October 2018 over a five-week period. Corporate participants were assigned to either the control or intervention group depending on the training session they attended. This was because initial training introduction sessions occurred in small to medium sized groups (2 to 22 people) and sessions involved different content depending on condition. Five training sessions were randomly assigned to receive the control presentation (n=41), and seven received the intervention (n=58). Condition membership was consistent throughout the study, unknown to participants, and no exclusion criteria for participation was enforced. The only inclusion criteria was age.
Consistent with our definition of resilience and recommendations provided by Chmitorz et al. (2018), the study was designed to assess the program outcomes in the context of a stressor event. Training sessions for both the corporate and community samples were therefore delivered prior to the busy Christmas period (2018). This time in the Australian calendar is recognized as a stressor, being related to a decrease in life satisfaction and emotional wellbeing (Mutz, 2016). It is also the busiest period for the participating organisation, with peak sales inducing high workload.

Our methodology was intended to examine whether the Self-Reflective Resilience Training (intervention) is superior to an active control group. The longitudinal design allowing the exploration of 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
Hair samples were collected to provide a measure of stress experience over a 1-month period. However, an insufficient number of hair samples were returned (only 5 samples from the control group were returned and 24 from the combined intervention groups).
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
Sex
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
The longitudinal changes between the groups were tested with the use of generalized estimation equation (GEE) models that emphasize the measurement of group change over time whilst accounting for within-subject variance over time (Hubbard, et al., 2010). The models of depression and anxiety specified a log link function, coupled with gamma scale to account for the positive skewness of scores, observed within each of the time points and within both intervention conditions. Other scales were normally distributed. Effect size estimates were calculated using Hedge’s g. All analyses were conducted using SPSS version 22. A significance level of p<.05 was applied.

A series of longitudinal mediation models were employed to investigate mechanisms that underpin change on the primary outcomes. These models were generated with the Hayes’ PROCESS macro using the serial mediation model option (Model 6; Hayes, 2016). In these serial models, the pre-treatment score of each primary outcome was entered as variable X, with three-month follow-up entered as the outcome variable (Y). Through this approach, the direct model effect is the change score over time, and the mediating pathways are those pathways the can underpin the change in the primary outcomes. This approach also enables us to structure the primary outcomes and mediators into longitudinal panel analysis, and test for indirect effects that represent causal pathways and reverse pathways (Falkenström, Finkel, Sandell, Rubel, & Holmgist, 2017). For the mediation analyses, the control group was excluded in order to directly investigate treatment related change. Given the similarities in intervention materials and procedures the intervention groups were combined to allow sufficient power for the analysis. However, intervention group type (corporate versus community) was controlled for in the analysis to adjust for variance attributable to sample type. All estimates were determined using a bootstrap procedure from models that resampled 5000 cases.

Missing data were considered for replacement. Initially we explored evidence of non-ignorable missing data (Little & Rubin, 2014). Patterns of missing cases were explored using a logistic regression and model building strategy outlined by Harrell (2015). All outcome, predictor, and demographic variables were initially included in the model. Variables were removed if they did not predict missing cases status in a stepwise manner (p-value in = .01; p-value out=.05). This analysis demonstrated that no pre-treatment variables predicted missing cases status post-intervention or at follow-up. Missing cases were therefore considered to be missing completely at random and were replaced through a longitudinal GEE model procedure (Karin, Dear, Heller, Crane, & Titov, 2018), adjusting for condition, time point, and a time by condition.

The design of this study, the sample and the approach to training is relatively novel and there were several unknown parameters that meant a power analysis could not be conducted accurately a priori. Therefore, we conducted a post hoc power analysis for all GEE models of change in outcomes and process variables in order to determine the minimal differences to the rate of longitudinal change that could be refuted as false negatives. A power analysis was conducted using R software (R Core Team 2014) package ‘longpower’ (Donohue & Eland, 2013).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/09/2018
Actual
28/08/2018
Date of last participant enrolment
Anticipated
31/01/2019
Actual
8/11/2018
Date of last data collection
Anticipated
30/04/2019
Actual
21/05/2019
Sample size
Target
400
Accrual to date
Final
144
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
Country [1] 300018 0
Australia
Funding source category [2] 300019 0
University
Name [2] 300019 0
Macquarie University
Country [2] 300019 0
Australia
Funding source category [3] 300027 0
Commercial sector/Industry
Name [3] 300027 0
Coca-Cola Amatil
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
Approved
Ethics committee name [1] 300871 0
Macquarie University Human Research Ethics Committee Medical Sciences [EC00448]
Ethics committee address [1] 300871 0
Ethics committee country [1] 300871 0
Australia
Date submitted for ethics approval [1] 300871 0
06/07/2018
Approval date [1] 300871 0
23/08/2018
Ethics approval number [1] 300871 0
5201830833792

Summary
Brief summary
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
[email protected]
Contact person for public queries
Name 85107 0
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
[email protected]
Contact person for scientific queries
Name 85108 0
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
[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
Participants have not consented to their individual participant data to be disclosed or published in any manner or for broader use beyond the specific research outlined in the consent forms. Participants have only consented to the release of group and average data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3424Ethical approval    File attached. 375512-(Uploaded-26-07-2019-08-43-22)-Study-related document.pdf
3425Informed consent form    File attached. 375512-(Uploaded-26-07-2019-08-43-29)-Study-related document.pdf



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.