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Trial registered on ANZCTR


Registration number
ACTRN12619001037190
Ethics application status
Approved
Date submitted
4/07/2019
Date registered
22/07/2019
Date last updated
2/12/2019
Date data sharing statement initially provided
22/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive-behavioral therapy for depressive symptoms in older adults living in residential aged care facilities: A cluster randomised-controlled trial in Australia
Scientific title
ELders AT Ease Program (ELATE): A cluster randomised controlled trial of a sustainable and scalable mental health service for Australian residential aged care facilities
Secondary ID [1] 298466 0
NHMRC GNT1150902
Universal Trial Number (UTN)
Trial acronym
ELATE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 313228 0
Anxiety 313653 0
Condition category
Condition code
Mental Health 311673 311673 0 0
Depression
Mental Health 311731 311731 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves a multi-component approach for improving depressive symptoms. The approach comprises three components: (1) ELATE Resident, (3) ELATE Family/Friend and (3) ELATE Staff. Residential aged care facilities allocated to the intervention condition receive all three components, during the study period.

Component 1: ELATE Resident: Interventions will be provided by mental health trainees (MHTs) enrolled in professional programs in counselling, social work or psychology. The MHTs meet face-to-face and one-on-one with the residents for 16 counselling sessions held every 1 – 2 weeks over 5 months (allowing for missed weeks due to ill health). Initial sessions (sessions 1 – 4) represent the engagement phase, where the focus is on the development of rapport with the resident (“client”) through conversation. The intermediate sessions (5 – 14) represent the problem clarification and treatment phase, where the counsellor and client discuss the presenting issues, background of the problem and impact of the problem on daily functioning. The final phase (sessions 15 -16) involves a review and consolidation of strategies for extending and/or maintaining treatment gains. Consistent with evidence-based protocols for improving mood in older adults, family members or friends or the resident, and staff may also attend resident treatment sessions if required, and collaboratively inform treatment planning and implementation. The program is individually tailored and paced according to the cognitive and physical capacity of the resident. The duration of counselling sessions is 30 to 60 minutes, depending on the needs and attention span of the client. The psychosocial interventions are based on CBT, behavioural activation, and reminiscence therapy.

Component 2: ELATE Family/Friend: (1) Monthly support group: Family/friends of participating residents will be invited to join an on-site monthly support group. The group will provide family/friends a forum for peer support. It will also provide information on a range of strategies for supporting their relative or friend, which in turn can improve their sense of competence in interacting positively with their relative. The “beyondblue guide for carers” will be distributed to carers, and form the framework for the monthly groups. (2) Collateral activity: Family/friends will be invited to contribute to the administration of psychosocial interventions, by joining treatment sessions with the MHT and resident, and/or encouraging, reminding or helping relatives do therapeutic activities between sessions. Joint meetings will be facilitated as required between carers and staff to inform treatment planning and shared care agreements. (3) The Carer Information Workshop: Family/friends will be invited to attend a workshop (up to 4 hours) focused on understanding depression, anxiety and treatment strategies and how they can support their relative or friend living in residential care.

Component 3: ELATE Staff: (1) Monthly consultative meetings: Information about a resident will be discussed in consultative meetings between MHTs and facility staff with the aim of tailoring interventions to suit the resident’s needs, preferences and capacity. MHTs and staff will collaboratively develop treatment plans for implementation during sessions and between sessions. (2) Collateral activity: Staff will be invited to assist with such activities if required. Staff will be encouraged to participate in sessions, and to assist residents implement, complete and record between-session therapeutic activities. (3) The Staff Information Workshop: A workshop (up to 4 hours) will be delivered to staff to assist them to assess and manage resident depression, anxiety and suicide ideation. Staff will be recommended to augment face-to-face training with follow-up online content (beyondblue’s online course “Professional Education to aged care”) and reading (beyondblue’s “What works for improving the emotional wellbeing in older adults”).

The ELATE Carer and Staff Information Workshops will occur during the first 4 weeks of the ELATE Resident treatment. The ELATE monthly family support groups and staff consultative meetings will then be held towards the end of each month for the remainder of the treatment period (i.e. months 2-5).

All MHTs will complete a purpose developed treatment Integrity self-report measure of each treatment module throughout treatment with each resident participant. Clinical supervisors will also complete treatment integrity measures for each treatment module per resident participant, as well as the Cognitive Therapy Ratings Scale for a random selection of treatment recordings.
Intervention code [1] 314739 0
Treatment: Other
Comparator / control treatment
Facilities in the control treatment will continue with usual care. Usual care is defined as a continuation of normally scheduled activities within the aged care facility. These facilities will only be provided with the beyondblue website address which contains up-to-date information on anxiety, depression and suicidal ideation and is currently available to all facilities online.
Control group
Active

Outcomes
Primary outcome [1] 320405 0
Resident mean Patient Health Questionnaire - 9 (PHQ-9) score
Timepoint [1] 320405 0
Baseline, 11 weeks post-randomisation, 22 weeks post-randomisation (primary timepoint), 34 weeks after randomisation.
Secondary outcome [1] 371492 0
Resident mean Geriatric Anxiety Inventory score
Timepoint [1] 371492 0
Baseline, 11 weeks post-randomisation, 22 weeks post-randomisation, 34 weeks after randomisation.
Secondary outcome [2] 371542 0
Change in residents' mean quality of life measured by the Quality of Life –Alzheimer’s Disease Scale- Nursing Home version (QOL-AD-NH) amd EQ-5D-5L.
Timepoint [2] 371542 0
Baseline, 11 weeks post-randomisation, 22 weeks post-randomisation, 34 weeks after randomisation.
Secondary outcome [3] 371543 0
Change in residents' suicidal ideation measured by the Paykel Suicide Scale
Timepoint [3] 371543 0
Baseline, 11 weeks post-randomisation, 22 weeks post-randomisation, 34 weeks after randomisation.
Secondary outcome [4] 371545 0
Change in staff knowledge of depression and anxiety measure by The Knowledge of Late Life Depression Scale — Revised
Timepoint [4] 371545 0
Baseline, 22 weeks post-randomisation, 34 weeks after randomisation
Secondary outcome [5] 371546 0
Change in carer stress on the Kingston Caregiver Stress Scale
Timepoint [5] 371546 0
Baseline, 22 weeks post-randomisation, 34 weeks after randomisation
Secondary outcome [6] 371547 0
Change in staff stress on the Strain in dementia care scale
Timepoint [6] 371547 0
Baseline, 22 weeks post-randomisation, 34 weeks after randomisation
Secondary outcome [7] 371548 0
Change in staff efficacy on the Confidence in working with depressed older people questionnaire
Timepoint [7] 371548 0
Baseline, 22 weeks post-randomisation, 34 weeks after randomisation
Secondary outcome [8] 371549 0
Change in carer self efficacy on the Kingston Caregiver Stress Scale
Timepoint [8] 371549 0
Baseline, 22 weeks post-randomisation, 34 weeks after randomisation
Secondary outcome [9] 371550 0
Mean Health care costs measure by health economic evaluation using medical records (hospital admissions, healthcare visits, medications)
Timepoint [9] 371550 0
Baseline, 22 weeks post-randomisation, 34 weeks after randomisation
Secondary outcome [10] 372578 0
Change in residents' family/friend knowledge of depression and anxiety measure by The Knowledge of Late Life Depression Scale — Revised
Timepoint [10] 372578 0
Baseline, 22 weeks post-randomisation, 34 weeks after randomisation
Secondary outcome [11] 377496 0
Change in resident Pittsburgh Sleep Quality Index score
Timepoint [11] 377496 0
Baseline, 11 weeks post-randomisation, 22 weeks post-randomisation, 34 months after randomisation
Secondary outcome [12] 377497 0
Change in Mental Health Trainee scores on the Knowledge of Late Life Depression Scale
Timepoint [12] 377497 0
Pre-training (before MHTs begin their training program for ELATE); Post-training (after MHTs complete their training program, but prior to commencement of treatment); Post-treatment (after MHTs have completed their last treatment session)
Secondary outcome [13] 377498 0
Change in Mental Health trainee Confidence in Working with Depressed Older People scale score. The change was made prior to enrollment commencement.
Timepoint [13] 377498 0
Pre-training (before MHTs begin their training program for ELATE); Post-training (after MHTs complete their training program, but prior to commencement of treatment); Post-treatment (after MHTs have completed their last treatment session)
Secondary outcome [14] 377499 0
Change in Mental Health Trainee scores on the Knowledge, Attitudes and Confidence scale.
Timepoint [14] 377499 0
Pre-training (before MHTs begin their training program for ELATE); Post-training (after MHTs complete their training program, but prior to commencement of treatment); Post-treatment (after MHTs have completed their last treatment session)
Secondary outcome [15] 377500 0
Change in Mental Health Trainee score on Pikes Peak Geropsychology Knowledge and Skill Assessment Tool
Timepoint [15] 377500 0
Pre-training (before MHTs begin their training program for ELATE); Post-training (after MHTs complete their training program, but prior to commencement of treatment); Post-treatment (after MHTs have completed their last treatment session)

Eligibility
Key inclusion criteria
1. Age of 65 years or older, and
2. Has significant depressive symptoms, as assessed by residential aged care facility (RACF) staff in one of three ways: (a) Cornell Scale for Depression in Dementia (CSDD) score of 9 or greater at most recent Aged Care Funding Instrument (ACFI) review (no older than six months prior) or (b) a score of 3 or greater on the Patient Health Questionnaire -2 (PHQ-2) or (c) by subjective impression of RACF staff if no recent ACFI review or PHQ-2 is available, AND
3. Has no significant cognitive impairment, as assessed by RACF staff in one of three ways: (a) Psychogeriatric Assessment Scale – Cognitive Impairment Scale (PAS-CIS; Jorm & Mackinnon, 1995) score of 9 or below at the most recent ACFI review (no older than six months prior) or (b) score of 21 or above on the resident's recent archived Mini-Mental Status Examination (MMSE) (last six months), or (c) by subjective impression of RACF staff if no recent ACFI review or MMSE is available, AND
4. Patient Health Questionnaire – 2 item version, score of 3 or more as assessed by research team at the screening interview, AND
5. Standardised MMSE score of 21 or greater as assessed by the research team at screening interview

Family/Friends eligibility criteria
1. Nominated by the resident, proxy or RACF staff (e.g., care manager) as an important source of support for the participating resident
2. Age of 18 years or older, and
3. Have sufficient proficiency in English, as assessed by facility or research staff

Facility staff eligibility criteria
1. Nominated by the resident, proxy or RACF staff (e.g., care manager) as an important source of care for the participating resident
2. Age of 18 years or older, and
3. Have sufficient proficiency in English, as assessed by facility or research staff
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Resident exclusion criteria
1.. Limited capacity to communicate verbally in English (due to a lack of English language proficiency), as assessed by facility or research staff), OR
2. Unable to complete study questionnaires or procedures due to health conditions as assessed by facility or research staff

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/07/2019
Actual
19/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
11
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 303009 0
Government body
Name [1] 303009 0
National Health and Medical Research Council (NHMRC)
Country [1] 303009 0
Australia
Funding source category [2] 303041 0
University
Name [2] 303041 0
Swinburne University of Technology
Country [2] 303041 0
Australia
Primary sponsor type
Individual
Name
Professor Sunil Bhar
Address
Department of Psychological Sciences
Faculty of Health, Arts and Design
Swinburne University of Technology
John Street, Hawthorn
Victoria 3122
Country
Australia
Secondary sponsor category [1] 303017 0
None
Name [1] 303017 0
Address [1] 303017 0
Country [1] 303017 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303560 0
Swinburne University Human Research Ethics Committee
Ethics committee address [1] 303560 0
Ethics committee country [1] 303560 0
Australia
Date submitted for ethics approval [1] 303560 0
Approval date [1] 303560 0
11/06/2019
Ethics approval number [1] 303560 0

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

Contacts
Principal investigator
Name 94086 0
Prof Sunil Bhar
Address 94086 0
Department of Psychological Sciences
Faculty of Health, Arts and Design
Swinburne University of Technology
John Street, Hawthorn
VIC, 3122
Country 94086 0
Australia
Phone 94086 0
+61 3 9214 8371
Fax 94086 0
Email 94086 0
sbhar@swin.edu.au
Contact person for public queries
Name 94087 0
Sunil Bhar
Address 94087 0
Department of Psychological Sciences
Faculty of Health, Arts and Design
Swinburne University of Technology
John Street, Hawthorn
VIC, 3122
Country 94087 0
Australia
Phone 94087 0
+61 3 9214 8371
Fax 94087 0
Email 94087 0
sbhar@swin.edu.au
Contact person for scientific queries
Name 94088 0
Sunil Bhar
Address 94088 0
Department of Psychological Sciences
Faculty of Health, Arts and Design
Swinburne University of Technology
John Street, Hawthorn
VIC, 3122
Country 94088 0
Australia
Phone 94088 0
+61 3 9214 8371
Fax 94088 0
Email 94088 0
sbhar@swin.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
I do not believe the study sponsor will allow this.


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
SourceTitleYear of PublicationDOI
EmbaseStudy protocol for ELders AT Ease (ELATE): a cluster randomised controlled trial of cognitive behaviour therapy to reduce depressive symptoms in aged care residents.2023https://dx.doi.org/10.1186/s12877-023-04257-7
N.B. These documents automatically identified may not have been verified by the study sponsor.