Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000634279
Ethics application status
Approved
Date submitted
6/04/2018
Date registered
23/04/2018
Date last updated
25/03/2022
Date data sharing statement initially provided
19/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
BAN-Dep: A Trial to Decrease the Prevalence of Depression in Australian Nursing Homes.
Scientific title
A randomised control trial of Behavioral Activation among older Australians living in Nursing homes to treat and prevent depression - The BAN-Dep Trial
Secondary ID [1] 294490 0
Nil known
Universal Trial Number (UTN)
Trial acronym
BAN-Dep
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Depression 307257 0
Condition category
Condition code
Mental Health 306377 306377 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention includes 2 components:
(1) Completion of the Professional Education to Aged Care (PEAC) e-learning program by care staff

(2) Implementation of a structured behavioural activation (BA) program.

All staff at Residential Aged Care Facilities (RACF) recruited into the study will complete the PEAC e-learning program at baseline via the Beyondblue website. They will be given 4 weeks to complete 7 modules: (i) understanding anxiety and depression, (ii) anxiety and depression in older people, (iii) promoting the mental health of community aged care clients, (iv) promoting the mental health of aged care residents, (v) identifying and responding to suicide in aged care settings, (vi) managing anxiety and depression in aged care clients and residents, (vii) looking after your mental health at work. The program was designed to address the specific needs of professionals working in the residential aged care sector and can be accessed using an internet browser (The address of the relevant website: https://www.beyondblue.org.au/about-us/about-our-work/older-adults-program/professional-education-in-to-aged-care-peac-program). Each module takes about 25 minutes to complete.

A Mental Health Champion (MHC) will be nominated by the Facility Manager for each facility (both control and intervention sites) and will be the central point of contact for the research team. All MHCs will be asked to ensure staff complete the PEAC e-learning program and upon successful completion a certificate of achievement will be granted. Copies of certificates for staff that have completed the PEAC e-learning program will be sent to the trial coordinator. Staff at all facilities will be required to incorporate knowledge gained from PEAC e-learning program into their daily work routine.

The BA training will be delivered to MHCs of intervention facilities in a group setting off site during the first 4 weeks by a trained BA therapist. The 12 hour training session is a validated structured program that has been shown to deliver benefits to older adults with depressive symptoms and incorporates 8 sessions of BA. These sessions address: (i) recognition of the symptoms of depression, (ii) the value of keeping a diary, (iii) types of activities, (iv) breaking jobs down into easier tasks, (v) the benefits of activities, (vi) finding ways to be active, (vii) spotting symptoms of depression and, (viii) action plan and activity scheduling.

The trained MHCs of intervention facilities will deliver the BA program to residents (participants) recruited by research staff from weeks 5-8 on a one to one basis working through the self–help workbook designed specifically for the study with each participant over a 4 week period. Recruitment of participants will be conducted by the research team at all RACFs. The BA therapist will provide weekly supervision via phone during the 4 week period. These supervision sessions will ensure the MHCs adhere to delivering the BA program to participants. Using knowledge gained through the PEAC e-learning program and principles of BA, they will identify symptoms of depression, encourage participants to complete activities from the workbook enhancing their daily routine, reduce avoidant behaviours and increase pleasurable behaviours.

The BA therapist will liaise with MHCs at week 10 to obtain feedback in relation to delivery of the intervention and if any concerns were raised by participants. They will continue to interact with GPs at the facilities and the BA therapist, should any issues arise that are of clinical concern in relation to the study.
Intervention code [1] 300783 0
Prevention
Intervention code [2] 300784 0
Behaviour
Comparator / control treatment
Beyondblue e-learning PEAC program alone.

Staff at the RACFs recruited into the study assigned to the control group will complete the PEAC e learning program at baseline via the Beyondblue website. They will be given 4 weeks to complete 7 modules and incorporate knowledge gained into their daily work routine.

Support staff and participants at control RACFs will receive a copy of the BA self help workbook at the of the study. This will be once the final participant recruited into the study has completed their 52 week follow up assessment.
Control group
Active

Outcomes
Primary outcome [1] 305392 0
Patient Health Questionnaire (PHQ-9)

A multipurpose instrument used for screening, diagnosing, monitoring and measuring the severity of depression. The PHQ-9 questionnaire incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms into a brief self report tool.
Timepoint [1] 305392 0
Outcome measures will be collected at baseline, 12, (primary time point) 26 and 52 weeks. All time points will be included in the analysis.
Secondary outcome [1] 345054 0
Generalised Anxiety Disorder (GAD-7) scale.

A self-administered 7 item instrument that uses some of the DSM-V criteria to identify GAD and measure the severity of symptoms.


Timepoint [1] 345054 0
Outcome measures will be collected at baseline, 12, 26 and 52 weeks. All time points will be included in the analysis.
Secondary outcome [2] 345055 0
Secondary outcomes include The Short Form (SF12) survey

Measuring the physical functioning and overall health related quality of life.
Timepoint [2] 345055 0
Outcome measures will be collected at baseline, 12, 26 and 52 weeks. All time points will be included in the analysis.
Secondary outcome [3] 345056 0
Secondary outcomes include Knowledge of Late Life Depression - revised (KLLD-R) Resident. Measuring resident knowledge of depression in a aged care setting.
Timepoint [3] 345056 0
Outcome measures will be collected at baseline, 12, 26 and 52 weeks. All time points will be included in the analysis.
Secondary outcome [4] 345167 0
Secondary outcomes include Knowledge of Late Life Depression - revised (KLLD-R) - staff. Measuring carers knowledge of depression in a aged care setting.
Timepoint [4] 345167 0
Outcome measures will be collected at baseline, 12, 26 and 52 weeks. All time points will be included in the analysis
Secondary outcome [5] 345649 0
Montreal Cognitive Assessment (MoCA) - Measure for mild cognitive dysfunction.

This assessment will assess different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.
Timepoint [5] 345649 0
Outcome measures will be collected at baseline, 12, 26 and 52 weeks. All time points will be included in the analysis.
Secondary outcome [6] 348317 0
Dejong Gierveld Loneliness scale. Six questions that measure measure social and emotional loneliness.
Timepoint [6] 348317 0
Outcome measures will be collected at Baseline,12, 26 and 52 weeks. All time points will be included in the analysis.
Secondary outcome [7] 348318 0
Lubben Social Network Scale-6 (LSNS-6). Measure for assessing the level of support available to an individual from family and friends.
Timepoint [7] 348318 0
Outcome measures will be collected at Baseline, 12, 26 and 52 weeks. All time points will be included in the analysis.

Eligibility
Key inclusion criteria
RACF:
Consent to be granted by RACF,
RACF manager to appoint MHC for their facility.
MHC must be able to communicate effectively in English.

Residents:
- 60 years or over
- Permanent residents of aged care facilities
- Screens positive on at least one of two questions known as the "Whooley" depression screening questions: low mood or decreased interest / enjoyment in usual activities.

Aged care facility staff:
Must be able to communicate effectively in English
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Mini-Mental State Examination (MMSE) score lower than 18 (moderate to severe cognitive impairment (those with dementia and MMSE equal to 18 and above will be eligible to participate),
- A disorder that impedes effective communication (e.g., severe sensory impairment),
- Active psychotic symptoms or suicidal ideation,
- PHQ-9 score less than 5 (i.e., no or minimal depressive symptoms),
- Difficulty communicating effectively in English,
- Failed (or are unable) to provide informed consent to participate.

MHC and aged care facility staff:
- Difficulty communicating effectively in English

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
100 Residential Aged Care Facilities will be assigned by central randomisation to the control or BA intervention group according to a random list of numbers generated by computer. We will contact the general managers of the RACFs that oversee activities and send a one page summary of the aims of this project to local managers of all relevant RACF, and follow this up with a telephone call that will seek a face to face appointment. During this meeting we will present more detailed information about the aims of the project and what participation would entail.

We will ask managers at the participating RACF to nominate a MHC. The local RACF managers and MHCs will facilitate recruitment of participants at the facility through the production of a list of names of potentially eligible residents based on the eligibility criteria. They will receive an information sheet and consent form and subsequently the visit of a research staff member who will answer any questions, complete screening to ascertain eligibility and baseline assessments once consent has been granted.

Group assignment will be concealed from RACF and research staff, as the duration of the control and active intervention will be similar, with the only difference being the BA training and supervision of MHC from intervention RACFs.

Participating RACFs will only be advised that the program aims to test the efficacy of mental health training on the mental health well-being of participants. Research staff involved in the collection of outcomes will remain blind to group assignment for the duration of the trial (they will not be involved in any aspect of the intervention and will be instructed to actively avoid discussing care issues with participants, RACF staff and other research staff).

Once the collection of all outcomes is complete, these staff members will be asked to ‘guess’ the group assignment of RACF in order to determine the effectiveness of blinding: certain control, likely control, unsure, likely BA, certain BA.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
100 RACFs will be assigned to the control or BA intervention group according to a random list of numbers generated by computer in blocks of 10 and stratified by city (40 in Perth and 60 in Melbourne).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All analyses will follow CONSORT guidelines and will be supervised by an experienced biostatistician. We will use standard descriptive statistics to compare basic sociodemographic and clinical data across treatment arms. The proportion of participants in each study group who present clinically significant symptoms of depression during follow up (i.e., PHQ-9 equal to or greater than 10) will be examined using mixed logit models for the analysis of panel data over 12, 26 and 52 weeks.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
24/09/2018
Actual
1/10/2018
Date of last participant enrolment
Anticipated
Actual
18/05/2021
Date of last data collection
Anticipated
Actual
17/12/2021
Sample size
Target
666
Accrual to date
Final
193
Recruitment in Australia
Recruitment state(s)
WA,VIC
Recruitment hospital [1] 10544 0
Royal Perth Hospital - Perth
Recruitment hospital [2] 10545 0
Royal Melbourne Hospital - Royal Park campus - Parkville
Recruitment postcode(s) [1] 22263 0
6000 - Perth
Recruitment postcode(s) [2] 22264 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 299114 0
Government body
Name [1] 299114 0
National Health Medical Research Council (NHMRC)
Country [1] 299114 0
Australia
Primary sponsor type
University
Name
The University of Western Australia - School of Medicine/Division of Psychiatry
Address
The Western Australian Center for Health & Ageing
6th Floor, MRF Building
50 Murray Street
Perth WA 6000
Country
Australia
Secondary sponsor category [1] 298390 0
None
Name [1] 298390 0
Address [1] 298390 0
Country [1] 298390 0
Other collaborator category [1] 280051 0
University
Name [1] 280051 0
University of Melbourne
Address [1] 280051 0
Gratton Street
Parkville
Victoria 3010
Country [1] 280051 0
Australia
Other collaborator category [2] 280052 0
Hospital
Name [2] 280052 0
The Royal Melbourne Hospital
Address [2] 280052 0
Melbourne Health Aged Care
300 Gratton Street
Parkville Victoria 3052
Country [2] 280052 0
Australia
Other collaborator category [3] 280053 0
University
Name [3] 280053 0
University of York - Dept of Health Sciences
Address [3] 280053 0
Hesslington
York
YO10 5DD
United Kingdom
Country [3] 280053 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300047 0
University of Western Australia
Ethics committee address [1] 300047 0
Ethics committee country [1] 300047 0
Australia
Date submitted for ethics approval [1] 300047 0
20/03/2018
Approval date [1] 300047 0
26/03/2018
Ethics approval number [1] 300047 0
RA/4/20/4234

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

Contacts
Principal investigator
Name 82382 0
Prof Osvaldo P. Almeida
Address 82382 0
The University of Western Australia
The WA Center for Health & Ageing (M577)
University of Western Australia
Stirling Highway, Perth, WA 6009
Country 82382 0
Australia
Phone 82382 0
+61 08 9224 4513
Fax 82382 0
+61 08 9224 0364
Email 82382 0
osvaldo.almeida@uwa.edu.au
Contact person for public queries
Name 82383 0
Osvaldo P. Almeida
Address 82383 0
The University of Western Australia
The WA Center for Health & Ageing (M577)
University of Western Australia
Stirling Highway, Perth, WA 6009
Country 82383 0
Australia
Phone 82383 0
+61 08 9224 0364
Fax 82383 0
+61 08 9224 0364
Email 82383 0
osvaldo.almeida@uwa.edu.au
Contact person for scientific queries
Name 82384 0
Osvaldo P. Almeida
Address 82384 0
The University of Western Australia
The WA Center for Health & Ageing (M577)
University of Western Australia
Stirling Highway, Perth, WA 6009
Country 82384 0
Australia
Phone 82384 0
+61 08 9224 4513
Fax 82384 0
+61 08 9224 0364
Email 82384 0
osvaldo.almeida@uwa.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
No data will be available/shared to those that are not part of the trial. Should any requests to share data come through consent would need to be sought from all participants in the study or the participant concerned.


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
EmbaseBehavioral Activation in Nursing Homes to Treat Depression (BAN-Dep): Results From a Clustered, Randomized, Single-Blinded, Controlled Clinical Trial.2022https://dx.doi.org/10.1016/j.jagp.2022.05.009
N.B. These documents automatically identified may not have been verified by the study sponsor.