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Trial registered on ANZCTR
Registration number
ACTRN12619000955112
Ethics application status
Approved
Date submitted
16/05/2019
Date registered
8/07/2019
Date last updated
8/07/2019
Date data sharing statement initially provided
8/07/2019
Date results information initially provided
8/07/2019
Type of registration
Retrospectively registered
Titles & IDs
Public title
Pleasant activities for well-being (PAW): Behavioural Activation in Residential Aged Care
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Scientific title
Pleasant activities for well-being (PAW): Behavioural activation for older adults with depressive symptoms living in residential aged care
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Secondary ID [1]
298201
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None
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Universal Trial Number (UTN)
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Trial acronym
PAW
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Depressive symptoms
312789
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Condition category
Condition code
Mental Health
311287
311287
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0
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Depression
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The behavioral activation intervention consisted of eight hours of face-to-face contact between resident participant and volunteer delivered over the course of 8 weeks. Sessions occurred in either one hour or 30 minute blocks, totaling one hour of contact per week. A buffer of up to three weeks was provided, should sessions need to be rescheduled e.g. to illness. Volunteers delivered the intervention to their assigned resident on site at the resident’s aged care facility.
Volunteers were required to attend two half-day training workshops delivered by a clinical psychologist prior to participating in the study. The training consisted of didadic material relating to behavioural activation and depression. It also included interactive role-plays, where volunteers practiced their behavioural activation skills. Volunteers also received weekly supervision phone calls from a member of the research team to support them in their delivery of behavioural activation.
The structure of each behavioural activation session is as follows:
1. Review Homework: Review resident’s activity schedule from the previous week. Discuss any problems or issues that arose while using the activity schedule.
2. Help resident to notice links between their behaviour and their mood: Using the activity schedule, volunteers inquired about any links that the resident noticed between their activities and mood.
3. Introduce and explore weekly theme: Volunteers were provided with trail specific resources for six domains of pleasant activities: Physical activity, relaxation, creativity, kindness, relationships and savouring. From weeks 3-8, volunteers were invited to introduce one of these themes to the resident, and explore a suitable activity relating to the theme that could be scheduled for the week ahead.
4. Activity scheduling for the week ahead: From weeks two onward, volunteers worked with the resident to plan pleasant activities for the week ahead using an activity scheduling sheet.
Adherence was measured through weekly phone calls with a member of the research team (to ensure at least one weekly visit had taken place), and also through collecting records of the activity sheets and session notes written up by the volunteers.
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Intervention code [1]
314437
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Treatment: Other
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Intervention code [2]
314438
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Behaviour
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Intervention code [3]
314439
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Lifestyle
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Comparator / control treatment
NA (one arm trial)
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Acceptability: On completion of the study, participants were asked to indicate their satisfaction with the intervention on visual analogue scale from 1 (least satisfied) to 10 (most satisfied).
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Assessment method [1]
320492
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Timepoint [1]
320492
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Post intervention (8-weeks)
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Secondary outcome [1]
370306
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Resident's positive well-being. Measured with the 8-item Flourishing Scale.
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Assessment method [1]
370306
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Timepoint [1]
370306
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Post intervention (8-weeks)
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Secondary outcome [2]
370307
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Resident's symptoms of anxiety: Measured using the 7-item Generalized Anxiety Questionnaire
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Assessment method [2]
370307
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Timepoint [2]
370307
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Post intervention (8 weeks)
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Secondary outcome [3]
370500
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Volunteer's positive well-being, measured with the 8-item Flourishing scale.
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Assessment method [3]
370500
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Timepoint [3]
370500
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Post intervention (8 weeks)
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Secondary outcome [4]
371789
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Resident's depressive symptoms, measured using the 9-item Patient Health Questionnaire
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Assessment method [4]
371789
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Timepoint [4]
371789
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Post intervention (8 weeks)
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Eligibility
Key inclusion criteria
Aged Care Residents:
Adult aged 65 or over who was a full-time resident in one of three Benatas aged care facilities in the Melbourne region, VIC, Australia. They were also required to have at least mild symptoms of depression, defined as a score of at least 6 on the PHQ-9.
Healthy volunteers, delivering the Behavioural activation intervention:
Healthy adult volunteers were required to be aged 18 or over, and were screened for suitability by the aged care facility.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Resident participants: Presence of a medically diagnosed severe cognitive impairment; non-English language.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NA
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
18/07/2018
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Date of last participant enrolment
Anticipated
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Actual
31/01/2019
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Date of last data collection
Anticipated
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Actual
12/06/2019
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Sample size
Target
20
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Accrual to date
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Final
18
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment postcode(s) [1]
26472
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3056 - Brunswick
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Recruitment postcode(s) [2]
26473
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3931 - Mornington
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Recruitment postcode(s) [3]
26474
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3018 - Altona
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Funding & Sponsors
Funding source category [1]
302744
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Charities/Societies/Foundations
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Name [1]
302744
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Brockhoff Foundation
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Address [1]
302744
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Suite 501/685 Burke Rd, Camberwell VIC 3124
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Country [1]
302744
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Australia
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Primary sponsor type
Other Collaborative groups
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Name
National Aging Research Institute
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Address
34-48 Poplar Rd, Parkville VIC 3052
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Country
Australia
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Secondary sponsor category [1]
302676
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University
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Name [1]
302676
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University of Melbourne
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Address [1]
302676
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Parkville VIC 3010
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Country [1]
302676
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
303344
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The University of Melbourne Human Ethics Sub Committee: Psychology, Health and Applied Sciences (PHAS)
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Ethics committee address [1]
303344
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Parkville, University of Melbourne, VIC 3010
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Ethics committee country [1]
303344
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Australia
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Date submitted for ethics approval [1]
303344
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16/03/2018
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Approval date [1]
303344
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16/04/2018
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Ethics approval number [1]
303344
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1851320.1
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Summary
Brief summary
This study will investigate the feasibility and acceptability of an eight-week behavioural activation programme, delivered by volunteers, designed to improve the wellbeing of residents in residential aged care facilities (RACFs), a group known to experience high levels of depression. The programme will involve training approximately 10 volunteers in behavioural activation (BA) techniques over two half-day training sessions. The volunteers will then work with aged care residents twice per week for eight weeks to deliver the BA programme. Behavioural activation is a well-supported treatment for depression that aims to improve mood by using a structured approach to increasing participation in enjoyable activities.
The primary aim of this study is to investigate the feasibility of an 8-week volunteer-led BA intervention for RACF residents. The secondary aim of this study is to collect preliminary data to investigate if the intervention shows promise in being effective in reducing psychological symptoms (depression, anxiety) and improving the well-being of approximately 20 aged care residents.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Briony Dow
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Address
93350
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National Aging Research Institute, 34-48 Poplar Rd, Parkville VIC 3052
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Country
93350
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Australia
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Phone
93350
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+61 (03) 8387 2305
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Fax
93350
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Email
93350
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[email protected]
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Contact person for public queries
Name
93351
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A/Prof Briony Dow
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Address
93351
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National Aging Research Institute, 34-48 Poplar Rd, Parkville VIC 3052
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Country
93351
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Australia
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Phone
93351
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+61 (03) 8387 2305
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Fax
93351
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Email
93351
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[email protected]
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Contact person for scientific queries
Name
93352
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A/Prof Briony Dow
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Address
93352
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National Aging Research Institute, 34-48 Poplar Rd, Parkville VIC 3052
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Country
93352
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Australia
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Phone
93352
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+61 (03) 8387 2305
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Fax
93352
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Email
93352
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
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.
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