Trial Review

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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
3/02/2022
Date data sharing statement initially provided
11/02/2020
Date results provided
3/02/2022
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 were provided with an information sheet detailing the purpose of the trial. They were also provided with a workbook comprising handouts for all six sessions when they commenced the program. These handouts included information about wellbeing, and introduced daily activity scheduling. These handouts were designed specifically for the study.

Procedures, activities, and/or processes used: Due to necessary social distancing measures, the nature of the intervention was changed from the original modality (4 x face-to-face group sessions and 2 x individual telephone calls) to a telehealth format (comprising 6 x telephone or video sessions dependent of participant's preferred medium). One group of 8 participants commenced the program prior to the introduction of social distancing measures, and completed 2 x group sessions face-to-face, then completed remaining sessions via telehealth. All other participants completed all sessions by telehealth. Session content remained consistent regardless of delivery mode, and included discussion of wellbeing and behavioural activation, followed by support in creating and implementing a schedule of activities that aligned with individuals' values.

Who will deliver the intervention: The program was facilitated by two postgraduate clinical psychologist trainees. The facilitators had previously had training in BA and group delivery through their postgraduate training and participated 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: Delivery mode was changed from mixed face-to-face group and individual telephone delivery to a telehealth format (comprising 6 x telephone or video sessions dependent of participant's preferred medium) due to introduction of social distancing measures. The first 8 participants completed two face-to-face group sessions prior to moving to telehealth. Telehealth sessions were conducted with individuals or, where both members of a couple were participating and requested it, couple sessions.

Number of times the intervention will be delivered and over what period of time: Sessions were conducted once per week for six weeks regardless of delivery mode. Face-to-face sessions for the first two weeks for the first 8 participants were approximately 90 minutes duration, plus breaks. Telehealth session duration varied between sessions and participants, but was typically approximately 60 minutes.

Adherence to the intervention was monitored through the use of an attendance record for group sessions, recording of telehealth sessions, and completion of session checklists.

Location where the intervention occurs: Face-to-face sessions conducted on-site at a community-based aged care accommodation provider. Telehealth sessions conducted remotely.
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
Sex
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
Completed
Date of first participant enrolment
Anticipated
Actual
21/01/2020
Date of last participant enrolment
Anticipated
30/03/2020
Actual
14/04/2020
Date of last data collection
Anticipated
27/07/2020
Actual
19/06/2020
Sample size
Target
28
Accrual to date
Final
18
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).
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
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
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
[email protected]
Contact person for public queries
Name 98103 0
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
[email protected]
Contact person for scientific queries
Name 98104 0
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
[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?
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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6230Informed consent form    378761-(Uploaded-18-12-2019-18-23-13)-Study-related document.docx
6231Ethical approval  [email protected]



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.