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Trial registered on ANZCTR


Registration number
ACTRN12620000126910
Ethics application status
Approved
Date submitted
16/01/2020
Date registered
11/02/2020
Date last updated
11/02/2020
Date data sharing statement initially provided
11/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Engage! A pilot study of brief behavioural activation to promote engagement
and wellbeing in older adults.
Scientific title
Engage! A pilot study of brief behavioural activation to promote engagement
and wellbeing in older adults.
Secondary ID [1] 299844 0
ARC LP170100461
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Aging 315237 0
Condition category
Condition code
Mental Health 313545 313545 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A group-based behavioural activation program designed to enhance activity engagement and well-being among older adults.

Physical or informational materials: Participants will be provided with an information sheet detailing the purpose of the trial. They will also be provided with handouts at each of the 4 sessions, which will include information about wellbeing, and introduce daily activity scheduling. These handouts were designed specifically for the study.

Procedures, activities, and/or processes used: 4 x group sessions will be held, where a discussion of wellbeing and behavioural activation will be facilitated, followed by support in creating ideas of activities that may align with individuals' values. 2 telephone calls between-sessions will also be included to assist in this process.

Who will deliver the intervention: The program will be facilitated by two postgraduate clinical psychologist trainees. The facilitators have previously had training in BA and group delivery through their postgraduate training and will participate in weekly on-site supervision meetings facilitated by Trevor Mazzucchelli who has been a registered clinical psychologist for 25 years, has a behaviour therapy background, and has undertaken previous research relating to behavioural activation.

Mode of delivery: mixed mode, a combination of group sessions and telephone calls to individual participants.

Number of times the intervention will be delivered and over what period of time: 4 x 90 minute group sessions and 2 x 30 minute telephone calls, over a 6-week period.
Week 1: 90 minute group session.
Week 2: 90 minute group session.
Week 3: 30 minute telephone call.
Week 4: 90 minute group session.
Week 5: 30 minute telephone call.
Week 6: 90 minute group session.

Adherence to the intervention will be monitored through the use of an attendance record for group sessions, and a log of telephone-call lengths.

Location where the intervention occurs: TBC (most likely a community centre).
Intervention code [1] 316100 0
Behaviour
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321997 0
Meaningful activity, as assessed by the Life Engagement Test (LET; Scheier et al., 2006).
Timepoint [1] 321997 0
At 3-months after commencement of intervention.
Secondary outcome [1] 376947 0
Social engagement, as assessed by network size, social support, and negative exchanges via a series of 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).
Timepoint [1] 376947 0
At 3-months after commencement of intervention.
Secondary outcome [2] 376948 0
Wellbeing, as assessed by the Scale of Positive and Negative Experience (Diener et al, 2010) and the Satisfaction with Life Scale (Diener, Emmons, Larsen, & Griffin, 1985).
Timepoint [2] 376948 0
At 3-months after commencement of intervention.
Secondary outcome [3] 376949 0
Physical functioning, as assessed by the Physical Functioning Subscale (Ware & Sherbourne, 1992).
Timepoint [3] 376949 0
At 3-months after commencement of intervention.
Secondary outcome [4] 376950 0
Psychological resources, as assessed by the Goal Adjustment Scale (GAS; Wrosch, Scheier, Miller, Schulz, & Carver, 2003).
Timepoint [4] 376950 0
At 3-months after commencement of intervention.
Secondary outcome [5] 376951 0
Hypothesised mechanisms, as assessed by the Behavioural Activation for Depression Scale-Short Form (BADS-SF; Manos, Kanter, & Luo, 2011) and The Engaged Living Scale-Short Form (Trindade, Ferreira, Pinto-Gouveia & Nooren, 2016).
Timepoint [5] 376951 0
At 3-months after commencement of intervention.
Secondary outcome [6] 376952 0
Client satisfaction, as assessed by a 19-item client satisfaction questionnaire and interview questions eliciting information on recruitment processes, program acceptability, perceived benefits and outcomes, as well as recommendations for future adaptations and implementations. These questions were designed specifically for the study.
Timepoint [6] 376952 0
At 3-months after commencement of intervention.
Secondary outcome [7] 379369 0
Bodily Pain, as assessed by a question on bodily pain (Ware & Sherbourne, 1992).
Timepoint [7] 379369 0
At 3-months after commencement of intervention.
Secondary outcome [8] 379370 0
Overall health, as assessed by a rating of overall health, and the Hospital Anxiety and Depression Scale (Zigmond & Snaith, 1983).
Timepoint [8] 379370 0
At 3-months after commencement of intervention.

Eligibility
Key inclusion criteria
Individuals will be eligible to participate if they are adults over the age of 65 years who are fluent in English, fully retired, and living in the community.
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Dementia diagnosis will be the only exclusion criterion, anticipating that people living with dementia may benefit from a more tailored intervention, and may experience the current program quite differently from other older adults.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
According to an a priori power analysis, 28 participants are required to capture a “medium” (f = 0.25) main effect for time at an alpha level of 0.05 (Cohen, 1988).

A series of Generalised Linear Mixed Models (GLMMs)—one for each of the outcome measures will be tested in order to determine whether outcomes change across time. The GLMMs will be implemented through SPSS’s GENLINMIXED procedure.

After transcription of audio-recordings qualitative data will be analysed using qualitative inductive thematic analysis as outlined by Braun and Clarke (2006).

Recruitment
Recruitment status
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)
WA

Funding & Sponsors
Funding source category [1] 304302 0
Government body
Name [1] 304302 0
Australian Research Council (LP170100461).
Address [1] 304302 0
11 Lancaster Pl
Australian Capital Territory 2609
Country [1] 304302 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent St
Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 304547 0
Individual
Name [1] 304547 0
Dr Trevor Mazzucchelli
Address [1] 304547 0
Curtin University
Kent St
Bentley WA 6102
Country [1] 304547 0
Australia
Secondary sponsor category [2] 304621 0
Individual
Name [2] 304621 0
Associate Professor Timothy Windsor
Address [2] 304621 0
Flinders University
Sturt Rd
Bedford Park SA 5042
Country [2] 304621 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304756 0
Curtin University Human Research Ethics Committee (HREC)
Ethics committee address [1] 304756 0
Kent St
Bentley WA 6102
Ethics committee country [1] 304756 0
Australia
Date submitted for ethics approval [1] 304756 0
02/08/2019
Approval date [1] 304756 0
14/10/2019
Ethics approval number [1] 304756 0
HRE2019-0694

Summary
Brief summary
This pilot program aims to boost wellbeing and engagement among people aged 65 years and older. It supports participants to plan and do personally meaningful and enjoyable activities to lead a more rewarding life. This behavioural activation approach has been demonstrated to help people become happier in studies around the world and is also a very effective treatment for depression.
Our goal in this pilot is to test whether a tailored version of this well established wellbeing intervention increases engagement, valued activity, health, and wellbeing in an older adult population.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98102 0
Dr Trevor Mazzucchelli
Address 98102 0
Curtin University
Kent St
Bentley WA 6102
Country 98102 0
Australia
Phone 98102 0
+61892667182
Fax 98102 0
Email 98102 0
trevor.mazzucchelli@curtin.edu.au
Contact person for public queries
Name 98103 0
Dr Trevor Mazzucchelli
Address 98103 0
Curtin University
Kent St
Bentley WA 6102
Country 98103 0
Australia
Phone 98103 0
+61892667182
Fax 98103 0
Email 98103 0
trevor.mazzucchelli@curtin.edu.au
Contact person for scientific queries
Name 98104 0
Dr Trevor Mazzucchelli
Address 98104 0
Curtin University
Kent St
Bentley WA 6102
Country 98104 0
Australia
Phone 98104 0
+61892667182
Fax 98104 0
Email 98104 0
trevor.mazzucchelli@curtin.edu.au

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?
Anyone who wishes to access it.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
TBC
What supporting documents are/will be available?
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 6230 0
Informed consent form
Citation [1] 6230 0
Link [1] 6230 0
Email [1] 6230 0
Other [1] 6230 0
Type [2] 6231 0
Ethical approval
Citation [2] 6231 0
Link [2] 6231 0
Email [2] 6231 0
trevor.mazzucchelli@curtin.edu.au
Other [2] 6231 0
Attachment [2] 6231 0
Summary results
No Results