Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001192875
Ethics application status
Approved
Date submitted
27/07/2021
Date registered
6/09/2021
Date last updated
6/09/2021
Date data sharing statement initially provided
6/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Engagement, Life and Meaning Study (ELMS): Effect of behavioural activation on engagement and well being among older adults.
Scientific title
The Engagement, Life and Meaning Study (ELMS): A trial of behavioural activation as a way to improve engagement and well being among non-clinical older adults.
Secondary ID [1] 304879 0
LP170100461
Universal Trial Number (UTN)
Trial acronym
ELMS
Linked study record
ACTRN12620000126910
The linked study is the pilot study where the feasibility and acceptability of the intervention materials, and mode of delivery were trialed. The current study was designed and refined based on the results of the linked study.

Health condition
Health condition(s) or problem(s) studied:
Healthy ageing 323005 0
Condition category
Condition code
Mental Health 320570 320570 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly allocated to one of conditions: the treatment group, and the active control group. Both conditions will incorporate a 6-session one-on-one intervention administered either via videoconferencing or by telephone. Participants can choose which mode of administration they would prefer. Sessions will occur weekly and will run for between 15 minutes to up to one hour. Participants will be provided with a program manual to guide their progress through the interventions.

The treatment condition will be based on a program adapted from the brief behavioural activation treatment for depression, which seeks to identify and promote engagement with reinforcing activities and contexts consistent with each participant’s values. The intervention materials were trialled in the pilot study (ACTRN12620000126910) and have since been adapted based on the results and feedback from pilot participants. Although behavioural activation is a structured approach to therapy, it allows for person-centred delivery and the activities will be determined by the participant, according to their values, interests, and circumstances. As part of this program, participants will learn about the theoretical underpinnings of behavioural activation, track their activities using activity diaries, identify their values and translate those into values-based activities, and schedule and complete those activities. They will also be encouraged to reflect on their enjoyment and meaning for each activity, and reflect on their mood for each day. They will be supported to notice any patterns that may occur between activities, importance and enjoyment ratings and mood. They will also be supported to troubleshoot and overcome barriers to completing these activities. Participants will be encouraged to commit fully to the program and to complete all between-session tasks, but there will not be a minimum requirement of time spent.

This program has been designed specifically for this intervention. Further details on the design and content of the intervention manual will be provided in the manuscript based on study no. ACTRN12620000126910. The manual is hoped to be publicly available upon study completion.

Facilitators will be trained in program delivery by one of the primary investigators, who is a registered psychologist and has years of clinical experience delivering behavioural activation and positive psychology intervention. Facilitators will be graduates in psychology, with some provisionally registered psychologists. Facilitators will be trained to administer the program by the registered psychologist and will be provided with extensive supporting material to assist. The psychologist, who will also administer some of the sessions, will be on hand to provide supervision when required.

For each week, facilitators will refer to running sheets to ensure they cover all the material for that week. They will also make notes on this sheet regarding whether, or how often the participant completed between-session tasks. One data collection is under way, these running sheets may also be used to facilitate formal fidelity checks. Ethics approval was obtained to audio record up to 15% of the sessions for an independent researcher to check facilitator adherence to the program.
Intervention code [1] 321270 0
Lifestyle
Intervention code [2] 321271 0
Behaviour
Comparator / control treatment
The active control group will participate in a multi-component positive psychology intervention. A positive psychology approach was selected due to its therapeutic focus on improving wellbeing, its lack of overlap with the principles of behavioural activation, and its accessibility. Furthermore, a multi-component psychology protocol can be designed to be equivalent to the behavioural activation protocol in terms of time commitment and weight of content.

The multi component positive psychology intervention consists of a series of short activities that aim to increase wellbeing. Individual activities were selected according to their reported effectiveness in improving wellbeing and their focus on cognitive reframing of existing behaviour and activities, as opposed to engaging in new behaviour. While this program has been designed for this study specifically, all the activities included have been adapted from previous multi-component positive psychology interventions (e.g. Seligman, Steen, Parks & Peterson, 2005; Gander, Proyer & Ruch, 2016). During this program, participants will introduced to the positive psychology and the importance of positive emotions, be taught two activities to foster gratitude, two activities to identify and engage with their character strengths, and three savouring-based activities. In addition, they will also learn about fostering forgiveness and a sense of optimism. Reflection exercises will also be provided.

Facilitators will be trained in program delivery by one of the primary investigators, who is a registered psychologist and has years of clinical experience delivering positive psychology interventions. Facilitators will be graduates in psychology, with some holding provision registration as a psychologist. Facilitators will be trained to administer the program by the registered psychologist and will be provided with extensive supporting material to assist. The psychologist, who will also administer
Control group
Active

Outcomes
Primary outcome [1] 328392 0
Any change in score on the Life Engagement Test (Scheier et al., 2006) relative to baseline, and to the control group. Clinical significance indicated by an moderate effect size (d = >.50)
Timepoint [1] 328392 0
Baseline (pre-intervention), one week and three months post-intervention (primary endpoint) relative to baseline, and to the control group.
Secondary outcome [1] 398893 0
Any change in score on the Goal Adjustment Scale (GAS; Wrosch, Scheier, Miller, Schulz, & Carver, 2003) relative to baseline, and to the control group.
Timepoint [1] 398893 0
Baseline (pre-intervention), one week and three months post-intervention
Secondary outcome [2] 399764 0
Any change in score on the Satisfaction with Life Scale (Diener, Emmons, Larsen, & Griffin, 1985) relative to baseline, and to the control group.Clinical significance indicated by an moderate effect size (d = >.50).
Timepoint [2] 399764 0
Baseline (pre-intervention), one week and three months post-intervention
Secondary outcome [3] 399765 0
Any change in score on the The Scale of Positive and Negative Experience (Diener et al, 2010) relative to baseline, and to the control group.
Timepoint [3] 399765 0
Baseline (pre-intervention), one week and three months post-intervention
Secondary outcome [4] 399766 0
Any change in score on the Hospital Anxiety and Depression Scale (Zigmond & Snaith, 1983) relative to baseline, and to the control group. Clinical significance indicated by an moderate effect size (d = >.50)
Timepoint [4] 399766 0
Baseline (pre-intervention), one week and three months post-intervention
Secondary outcome [5] 399768 0
Any change in score on the UCLA Loneliness Scale 10-item version (Russell, 1996). relative to baseline, and to the control group.
Timepoint [5] 399768 0
Baseline (pre-intervention), one week and three months post-intervention
Secondary outcome [6] 399776 0
Any change in score on one item from the bodily pain subscale, or the Physical Functioning Subscale from the Medical Outcomes Study 36 item short form health survey (Ware & Sherbourne, 1992) relative to baseline, and to the control group.
Timepoint [6] 399776 0
Baseline (pre-intervention), one week and three months post-intervention
Secondary outcome [7] 399777 0
Any change in score on a single item measure of self-rated health relative to baseline, and to the control group.
Timepoint [7] 399777 0
Baseline (pre-intervention), one week and three months post-intervention.
Secondary outcome [8] 399778 0
Any change in scores on our composite measure of social engagement that assesses social network size, social support, and negative exchanges compiled using questions that were used within the English Longitudinal Study of Ageing (Banks, 2019), and the Health and Retirement Study (Health and Retirement Study, 2004; Smith et al., 2013) relative to baseline, and to the control group
Timepoint [8] 399778 0
Baseline (pre-intervention), one week and three months post-intervention.
Secondary outcome [9] 399779 0
Scores on the Behavioural Activation for Depression Scale-Short Form (Manos, Kanter, & Luo, 2011) will be investigated as a potential mechanism.
Timepoint [9] 399779 0
Baseline (pre-intervention), one week and three months post-intervention
Secondary outcome [10] 399780 0
Scores on the Engaged Living Scale-Short Form (Trindade, Ferreira, Pinto-Gouveia & Nooren, 2016) will be investigated as a potential mechanism.
Timepoint [10] 399780 0
Baseline (pre-intervention), one week and three months post-intervention
Secondary outcome [11] 399781 0
Scores on the Self-Compassion Scale Short Form (Raes et al., 2011) will be investigated as a potential mechanism.
Timepoint [11] 399781 0
Baseline (pre-intervention), one week and three months post-intervention.
Secondary outcome [12] 399782 0
Within-person variation on scores on state self-compassion will be measured using the six item State Self-Compassion Scale – Short Form (Neff et al. 2021).
Timepoint [12] 399782 0
Assessed daily, for two weeks between session 4 and session 6 of the treatment and control interventions.
Secondary outcome [13] 399783 0
Within-person variation on affect scores using a measure of positive and negative affect adapted from Hülür et al. (2015).
Timepoint [13] 399783 0
Assessed daily, for two weeks between session 4 and session 6 of the treatment and control interventions.
Secondary outcome [14] 399784 0
Within-person variation in scores of exposure to stressful events measured using a shortened measure of the Daily Inventory of Stressful Events (Stawski et al., 2008)
Timepoint [14] 399784 0
Assessed daily, for two weeks between session 4 and session 6 of the treatment and control interventions.
Secondary outcome [15] 399785 0
Within-person variation on scores on eudaimonic well being measured using two short subscales of Meaning in Life, “presence” and “search” as used in Nezlek, Newman & Thrash (2017).
Timepoint [15] 399785 0
Assessed daily, for two weeks between session 4 and session 6 of the treatment and control interventions.

Eligibility
Key inclusion criteria
Older adults who score below the median on the Life Engagement Test ( < 26; Scheier et al. 2006)
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unable to participate in a telephone-based intervention due to hearing difficulties, language difficulties, or substantial cognitive impairment.

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 was not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated using a randomisation table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size considerations were based on the numbers of participants needed to detect a medium effect size difference between the BA and active control groups on the LET at 3-months post intervention. This represents a difference of approximately 2-units on the LET based on a previous community sample of midlife and older adults (Pearson et al., 2012). Using the Stata ‘power’ module with alpha = 0.05 and a group difference of d = 0.52 indicated that 60 participants per group were required for power = 0.8. Analyses will incorporate multilevel modelling techniques that account for non-independence (i.e., multiple assessments nested within individuals) of observations (e.g., Hoffman & Stawski, 2009).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
28/07/2021
Date of last participant enrolment
Anticipated
1/12/2021
Actual
Date of last data collection
Anticipated
31/03/2022
Actual
Sample size
Target
120
Accrual to date
9
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 309253 0
Government body
Name [1] 309253 0
Australian Research Council (LP170100461).
Country [1] 309253 0
Australia
Funding source category [2] 309259 0
Commercial sector/Industry
Name [2] 309259 0
ECH Inc
Country [2] 309259 0
Australia
Funding source category [3] 309260 0
Government body
Name [3] 309260 0
City of Onkaparinga
Country [3] 309260 0
Australia
Funding source category [4] 309261 0
Government body
Name [4] 309261 0
Office for Ageing Well
Country [4] 309261 0
Australia
Primary sponsor type
Individual
Name
Assoc Prof Tim Windsor
Address
College of Education, Psychology and Social Work
Flinders University
Sturt Rd
Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 310223 0
Individual
Name [1] 310223 0
Dr Julia Turner Scott
Address [1] 310223 0
College of Education, Psychology and Social Work
Flinders University
Sturt Rd
Bedford Park SA 5042
Country [1] 310223 0
Australia
Secondary sponsor category [2] 310233 0
Individual
Name [2] 310233 0
Dr Trevor Mazzucchelli
Address [2] 310233 0
School of Psychology
Curtin University
Kent St
Bentley WA 6102
Country [2] 310233 0
Australia
Secondary sponsor category [3] 310234 0
Individual
Name [3] 310234 0
Emeritus Professor Mary Luszcz
Address [3] 310234 0
College of Education, Psychology and Social Work
Flinders University
Sturt Rd
Bedford Park SA 5042
Country [3] 310234 0
Australia
Secondary sponsor category [4] 310235 0
Individual
Name [4] 310235 0
Assoc Prof Ruth Walker
Address [4] 310235 0
College of Nursing and Health Sciences
Flinders University
Sturt Rd
Bedford Park SA 5042
Country [4] 310235 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309098 0
Flinders University Human Research Ethics Committee
Ethics committee address [1] 309098 0
Ethics committee country [1] 309098 0
Australia
Date submitted for ethics approval [1] 309098 0
19/09/2018
Approval date [1] 309098 0
05/12/2018
Ethics approval number [1] 309098 0
8172

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

Contacts
Principal investigator
Name 112966 0
A/Prof Tim Windsor
Address 112966 0
College of Education, Psychology and Social Work
Flinders University
Sturt Rd
Bedford Park SA 5042
Country 112966 0
Australia
Phone 112966 0
+61 8 8201 7588
Fax 112966 0
Email 112966 0
[email protected]
Contact person for public queries
Name 112967 0
Tim Windsor
Address 112967 0
College of Education, Psychology and Social Work
Flinders University
Sturt Rd
Bedford Park SA 5042
Country 112967 0
Australia
Phone 112967 0
+61 8 8201 7588
Fax 112967 0
Email 112967 0
[email protected]
Contact person for scientific queries
Name 112968 0
Tim Windsor
Address 112968 0
College of Education, Psychology and Social Work
Flinders University
Sturt Rd
Bedford Park SA 5042
Country 112968 0
Australia
Phone 112968 0
+61 8 8201 7588
Fax 112968 0
Email 112968 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, after de-identification.
When will data be available (start and end dates)?
Start: Within 12 months of publications arising from the project.
End: No end date determined.
Available to whom?
Any researchers who wish to access it, and agree to comply with ethics requirements re data storage and access
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Email principal investigator ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12679Informed consent form    To be available upon study completion
12680Study protocol    To be available upon study completion
12681Ethical approval    To be available upon study completion



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA behavioural activation intervention to increase engagement with life and wellbeing in older adults: Study protocol for a randomised controlled trial.2022https://dx.doi.org/10.1186/s40359-022-00988-1
N.B. These documents automatically identified may not have been verified by the study sponsor.