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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
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pleasant activities for well-being (PAW): Behavioural Activation in Residential Aged Care
Scientific title
Pleasant activities for well-being (PAW): Behavioural activation for older adults with depressive symptoms living in residential aged care
Secondary ID [1] 298201 0
None
Universal Trial Number (UTN)
Trial acronym
PAW
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depressive symptoms 312789 0
Condition category
Condition code
Mental Health 311287 311287 0 0
Depression

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 314437 0
Treatment: Other
Intervention code [2] 314438 0
Behaviour
Intervention code [3] 314439 0
Lifestyle
Comparator / control treatment
NA (one arm trial)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320492 0
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).
Timepoint [1] 320492 0
Post intervention (8-weeks)
Secondary outcome [1] 370306 0
Resident's positive well-being. Measured with the 8-item Flourishing Scale.
Timepoint [1] 370306 0
Post intervention (8-weeks)
Secondary outcome [2] 370307 0
Resident's symptoms of anxiety: Measured using the 7-item Generalized Anxiety Questionnaire
Timepoint [2] 370307 0
Post intervention (8 weeks)
Secondary outcome [3] 370500 0
Volunteer's positive well-being, measured with the 8-item Flourishing scale.
Timepoint [3] 370500 0
Post intervention (8 weeks)
Secondary outcome [4] 371789 0
Resident's depressive symptoms, measured using the 9-item Patient Health Questionnaire
Timepoint [4] 371789 0
Post intervention (8 weeks)

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Resident participants: Presence of a medically diagnosed severe cognitive impairment; non-English language.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
18/07/2018
Date of last participant enrolment
Anticipated
Actual
31/01/2019
Date of last data collection
Anticipated
Actual
12/06/2019
Sample size
Target
20
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 26472 0
3056 - Brunswick
Recruitment postcode(s) [2] 26473 0
3931 - Mornington
Recruitment postcode(s) [3] 26474 0
3018 - Altona

Funding & Sponsors
Funding source category [1] 302744 0
Charities/Societies/Foundations
Name [1] 302744 0
Brockhoff Foundation
Country [1] 302744 0
Australia
Primary sponsor type
Other Collaborative groups
Name
National Aging Research Institute
Address
34-48 Poplar Rd, Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 302676 0
University
Name [1] 302676 0
University of Melbourne
Address [1] 302676 0
Parkville VIC 3010
Country [1] 302676 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303344 0
The University of Melbourne Human Ethics Sub Committee: Psychology, Health and Applied Sciences (PHAS)
Ethics committee address [1] 303344 0
Ethics committee country [1] 303344 0
Australia
Date submitted for ethics approval [1] 303344 0
16/03/2018
Approval date [1] 303344 0
16/04/2018
Ethics approval number [1] 303344 0
1851320.1

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

Contacts
Principal investigator
Name 93350 0
A/Prof Briony Dow
Address 93350 0
National Aging Research Institute, 34-48 Poplar Rd, Parkville VIC 3052
Country 93350 0
Australia
Phone 93350 0
+61 (03) 8387 2305
Fax 93350 0
Email 93350 0
b.dow@nari.edu.au
Contact person for public queries
Name 93351 0
Briony Dow
Address 93351 0
National Aging Research Institute, 34-48 Poplar Rd, Parkville VIC 3052
Country 93351 0
Australia
Phone 93351 0
+61 (03) 8387 2305
Fax 93351 0
Email 93351 0
b.dow@nari.edu.au
Contact person for scientific queries
Name 93352 0
Briony Dow
Address 93352 0
National Aging Research Institute, 34-48 Poplar Rd, Parkville VIC 3052
Country 93352 0
Australia
Phone 93352 0
+61 (03) 8387 2305
Fax 93352 0
Email 93352 0
b.dow@nari.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.