Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001345673
Ethics application status
Approved
Date submitted
2/10/2023
Date registered
20/12/2023
Date last updated
20/12/2023
Date data sharing statement initially provided
20/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the effectiveness of the Enhanced Management of home-Based Elders with Depression (EMBED) program in reducing depression among older adults receiving in-home aged care.
Scientific title
Cluster randomised controlled trial of the effectiveness and cost-effectiveness of the Enhanced Management of home-Based Elders with Depression (EMBED) program in reducing depression among older adults receiving in-home aged care.
Secondary ID [1] 310367 0
Nil
Universal Trial Number (UTN)
Trial acronym
EMBED Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 331108 0
Anxiety 331763 0
Condition category
Condition code
Mental Health 327894 327894 0 0
Depression
Mental Health 328510 328510 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is an individual psychological assessment and treatment program for depression designed specifically for the in-home aged care setting, delivered to home care recipients in addition to care as usual.

All participants in the intervention arm will take part in a clinical assessment with a mental health clinician via telehealth (telephone or video), to confirm treatment approach and set initial treatment goals.

There are three levels of treatment, designed for older people with mild, moderate, or severe levels of depressive symptoms. The treatment period is 12 weeks, with different treatment intensity (number of sessions with a clinician) and content, dependent on the severity of clients’ symptoms (based on score on the Patient Health Questionnaire- 9).

Each clinical treatment session is approximately 60 minutes duration. Sessions will be delivered via telehealth (telephone or video). Participants will receive guidance in identifying and implementing strategies designed to reduce symptoms of depression, using a range of self-help and psychological resources. A specifically designed digital platform will provide access to digital resources for participants who would like to use this approach.

There are three treatment levels to which each participant receiving treatment is assigned, based on the severity of their depressive symptoms:
Level 1 (mild symptoms of depression): Psychoeducation plus selected lifestyle strategies, delivered using guided self-help (2 sessions with a clinician, at weeks 1 and 3).
Level 2 (moderate symptoms of depression): Level 1 plus behavioural activation (6 sessions with a clinician in total, at weeks 1, 3, 5, 7, 9, 11).
Level 3 (severe symptoms of depression): Level 1 plus Level 2 plus collaborative care (10 sessions in total, at weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 11).

More details on the content of each treatment program is below:

Level 1: All participants complete a psychoeducation module, which includes understanding low mood and depression, addressing stigma of mental health and ageing, and provide information to the participant to how to introduce new activities into their daily life. In addition, participants will select one or two of the following optional modules: (1) physical activity; (ii) social connections; (iii) healthy diet; (iv) sleep; (v) relaxation training; (vi) mindfulness meditation. Participants are provided with resources to work through using a self-help approach, with initial guidance and instruction from the mental health clinician over two sessions. Resources may be paper based (booklet) or digital, according to clients’ preferences and circumstances. For each optional module, the client identifies a goal and makes a plan to achieve the goal, using structured worksheets, and tracks their use of the strategies. Clients are encouraged to implement the strategies over 12 weeks.

Level 2: In addition to the psychoeducation and lifestyle strategies described for Level 1, participants in Level 2 will receive 4 sessions of behavioural activation (total 6 sessions). Treatment is delivered by the mental health clinician via fortnightly sessions over 12 weeks, according to a structured clinical treatment manual. Behavioural activation helps clients to engage in personally rewarding activities to counter the negative feelings and withdrawal that are typical of depression. Clients use activity monitoring worksheets to track their mood associated with daily activities and identify patterns in their behaviours and the connections between activity engagement and mood. Through discussion of life values and goals, and the use of structured activity checklists, clients identify activities they would like to increase in their daily lives – focusing on those that are meaningful, build a sense of mastery and bring pleasure. Clients are assisted by the clinician in creating and tracking a schedule of activities. Guidance is also provided in addressing barriers that emerge in implementing activities, including training in problem-solving, motivational interviewing, and emotional regulation to address barriers, tailored to the needs of each client. The final session will review progress and discuss how to maintain use of the strategies, as well as how to implement new strategies into the future. A member of the client’s care staff (e.g., Care Coordinator) will be invited to join this session, to support the client moving forward. Tailored resources (i.e., structured activity checklists) will enable clients to track engagement with treatment strategies.

Level 3: In addition to the components described for Level 2, participants in Level 3 will receive an additional 4 sessions, to meet their individual needs - for example, to help the client apply the strategies or to address additional comorbidities or problems faced by the client that impact on their mood. Tailored resources will be provided, as required. A treatment manual will provide guidance to clinicians in implementing treatment. In addition, the mental health clinician will contact the client’s GP and other relevant specialists already involved in their care, via email and notify them that the client is participating in the EMBED program. Information will be provided on the client’s score on the PHQ-9, as well as a description of the core EMBED treatment sessions that will be provided by the mental health clinician, and a recommendation to conduct a medication review. This will be followed up by a telephone call, to discuss a collaborative treatment approach to support the older person, tailored to meet their individual symptoms, circumstances, and preferences. The mental health clinician delivers a total of 10 sessions to clients in Level 3 over 12 weeks (including any joint sessions with other health providers).

The mental health clinician will work closely with aged care staff and collaborate with participants’ GPs and other relevant health care providers (e.g., geriatricians, mental health providers) as required. Treatments will incorporate input from senior aged care staff (e.g., Care Coordinators), and engage direct care staff in the home, to support and encourage clients to employ the psychological strategies. Family and other informal carers will be actively engaged throughout the program, where available and appropriate, to support the client. Resources are provided to these informal carers to provide information and guidance in supporting the client.

Client treatment adherence will be reported by clinicians providing treatment - they will complete a log of session attendance for each client, including their perspectives on client engagement with therapeutic strategies and the types of strategies employed.
Intervention code [1] 326768 0
Treatment: Other
Comparator / control treatment
The control is care as usual. This includes any medications administered by healthcare providers, as well as an aged care plan tailored to meet the older person's individual care needs. Typically, care plans do not include active treatments for depression.
Control group
Active

Outcomes
Primary outcome [1] 335736 0
Symptoms of depression, measured using the Primary Health Questionnaire - 9 (PHQ-9). The PHQ-9 is a widely used self-rated questionnaire to assess severity of depression and measure treatment response, with scores ranging from 0-27.
Timepoint [1] 335736 0
The PHQ-9 will be administered at baseline, 12 weeks from baseline (post-intervention; primary timepoint) and 24 weeks from baseline (follow-up).

The 12-week endpoint (post-intervention; T2) is identified as the primary endpoint.
Secondary outcome [1] 425420 0
Late-life depression, measured using the Geriatric Depression Scale - 15 item.
Timepoint [1] 425420 0
Baseline, 12 weeks from baseline (post-intervention) and 24 weeks from baseline (follow-up).

Secondary outcome [2] 427400 0
Symptoms of anxiety, measured using the Generalised Anxiety Disorder (GAD-7).
Timepoint [2] 427400 0
Baseline, 12 weeks from baseline (post-intervention) and 24 weeks from baseline (follow-up).
Secondary outcome [3] 427401 0
Health-related Quality of Life, measured using the Assessment of Quality of Life (AQol-4D)
Timepoint [3] 427401 0
Baseline, 12 weeks from baseline (post-intervention) and 24 weeks from baseline (follow-up).
Secondary outcome [4] 427402 0
Loneliness, measured using the UCLA Loneliness Scale - 6-item (RULS-6).
Timepoint [4] 427402 0
Baseline, 12 weeks from baseline (post-intervention) and 24 weeks from baseline (follow-up).
Secondary outcome [5] 427403 0
Perceived depression stigma, measured using the Depression Stigma Scale, Personal Subscale.
Timepoint [5] 427403 0
Baseline, 12 weeks from baseline (post-intervention) and 24 weeks from baseline (follow-up).
Secondary outcome [6] 427404 0
Healthcare and aged care service usage, from data collected from linkage with Silverchain records and linkage with other administrative datasets. Includes mental health service usage.
Timepoint [6] 427404 0
3 years prior to baseline to 3 years post-baseline.
Secondary outcome [7] 427405 0
Treatment satisfaction, measured using the Client Satisfaction Questionnaire. This outcome is measured only to those who were allocated to the intervention arm (to receive EMBED treatment).
Timepoint [7] 427405 0
12 weeks after baseline (post-intervention).
Secondary outcome [8] 427406 0
Adverse events, associated with participation in the trial. This include suicidal ideation and behaviour, which will be monitored using Q9 of the PHQ-9 (primary outcome), with follow-up assessment using the Columbia protocol for those who indicate some level of suicidal ideation. No other adverse events have been identified as potentially linked to participation in this study; however, the study team will investigate any adverse events reported by participants or their care team.
Timepoint [8] 427406 0
Baseline, 12 weeks from baseline (post-intervention) and 24 weeks from baseline (follow-up).
Secondary outcome [9] 428637 0
Social isolation, measured using the Duke Social Support Index (DSSI)
Timepoint [9] 428637 0
Baseline, 12 weeks from baseline (post-intervention) and 24 weeks from baseline (follow-up).
Secondary outcome [10] 429610 0
Self-rated health, measured using the first item of the SF-12, asking individuals to rate their health overall.
Timepoint [10] 429610 0
Baseline, 12 weeks from baseline (post-intervention) and 24 weeks from baseline (follow-up).



Secondary outcome [11] 429612 0
Engagement in meaingful activity, measured using a revised version of the Meaningful Activity in Residential Care (MARC) scale.
Timepoint [11] 429612 0
Baseline, 12 weeks from baseline (post-intervention) and 24 weeks from baseline (follow-up).

Eligibility
Key inclusion criteria
.65 years of age or older.

Silverchain CHSP (Commonwealth home support programme) or HCP (Home care package) client.

Receipt of personal care, social, allied health or nursing services from Silverchain.

Current depressive symptoms: Participants with depressive symptoms are identified in two steps: (i) screening using the first two items of the PHQ-9 (also known as the PHQ-2 screening tool) - a score of 2 or more is required: and (ii) administration of the full PHQ-9 - a score of 5 or more is required.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Receiving only domestic support or gardening services as part of their CHSP or HCP service

Current receipt of psychological therapy for low mood or depression outside of the trial (i.e., current treatment by a psychological practitioner such as psychologist, counsellor, or other health care professional)

Moderate or severe cognitive impairment (A score of 18 or lower on the Telephone Administered Mini Mental State Examination (TMMSE), and/or presence of a diagnosis of cognitive impairment or dementia on the care record).

Severe acute medical illness likely to complicate participation in the trial.

Insufficient proficiency in English to take part in the trial.

Difficulty communicating over the telephone and/or video call

Diagnosis of one or more of the following psychiatric conditions: Schizophrenia or other psychotic disorder, bipolar disorder, alcohol or substance use disorder

Presence of severe suicidal ideation (classified as high risk on the Columbia-Suicide Severity Rating Scale, with (i) an intention to act on suicidal thoughts or (ii) suicide attempts within previous 3 months)

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)
Silverchain service sites are the unit of randomisation. Randomisation schedules are remotely and independently constructed by a researcher prior to the recruitment of participants who is not involved in participant recruitment or statistical analysis. The computer-generated random sequence is available to this researcher only.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation is completed via 1:1 ratio utilising a minimisation approach, which aims to ensure that treatment arms are balanced based on pre-determined factors. Factors will include state (WA and SA), the size of the service (using a median split to determine large and small sites) and metropolitan versus regional/rural/remote service.
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 840 participants will have 80% power to detect an effect size of 0.4 at 12 weeks with a two-sided significance level of 0.05. That is, 30 individuals will be recruited in each site in each period of the trial. This calculation, conducted using the Shiny CRT calculator, provides a minimum of 80% power for a range of intracluster correlations (ICCs) and cluster autocorrelations (CACs): for ICCs up to 0.065 and CACs up to 0.90, as well as a coefficient of variation (CV) of cluster size of 0.82. Allowing for attrition of 20% (based on previous trials), recruitment of a sample of 1050 is sufficient for this trial.

Data from individual participants will be analysed according to the randomisation of their Silverchain site, with all data analysed in accordance with intention-to-treat principles. Reporting of results will follow the CONSORT statement for cluster randomised trials. A per protocol analysis will be conducted as a secondary analysis. Descriptive statistics will be presented by study period and by Silverchain site. For continuous outcome measures including the primary outcome, differences in mean change (baseline minus follow-up) will be compared between groups using linear mixed models, including fixed effects for study period, the baseline value of the outcome variable and stratification variables. Since each participant provides outcome measures at two time points (12 weeks and 24 weeks) terms for time point and an interaction between time point and intervention will be included. Random effects will be included for site, period within site, and individual within period. The Kenward-Roger correction will be applied to account for the small number of sites. Binary outcomes will be analysed by fitting a mixed-effects regression model with a binomial distribution and identity link function, including fixed effects and random effects as specified above, with results presented as risk differences and 95% confidence intervals. In addition, a relative risk will be estimated by fitting a mixed-effects regression model with a binomial distribution and a log link. Multiple imputation will be applied to missing individual-level data from Silverchain sites which do not withdraw from the study prior to data collection and have recruited at least one participant.

A cost-utility analysis will be undertaken with quality adjusted life year gained over the follow-up period for each participant, based on AQoL-4D responses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/12/2023
Actual
Date of last participant enrolment
Anticipated
31/01/2025
Actual
Date of last data collection
Anticipated
31/07/2025
Actual
Sample size
Target
1050
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment hospital [1] 25573 0
Silverchain - Osborne Park
Recruitment postcode(s) [1] 41395 0
6017 - Osborne Park

Funding & Sponsors
Funding source category [1] 314572 0
Government body
Name [1] 314572 0
Department of Health and Aged Care - MRFF Dementia Ageing and Aged Care
Country [1] 314572 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Silverchain
Address
Silverchain House, 6 Sundercombe Street, Osborne Park, WA 6017
Country
Australia
Secondary sponsor category [1] 316534 0
None
Name [1] 316534 0
Address [1] 316534 0
Country [1] 316534 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313606 0
Monash University Human Ethics Research Committee
Ethics committee address [1] 313606 0
Ethics committee country [1] 313606 0
Australia
Date submitted for ethics approval [1] 313606 0
08/08/2023
Approval date [1] 313606 0
13/09/2023
Ethics approval number [1] 313606 0
39594

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

Contacts
Principal investigator
Name 128726 0
A/Prof Tanya Davison
Address 128726 0
Silverchain, Level 27, 385 Bourke Street, Melbourne, VIC 3000
Country 128726 0
Australia
Phone 128726 0
+61 0408 394 218
Fax 128726 0
Email 128726 0
[email protected]
Contact person for public queries
Name 128727 0
Helen Daniels
Address 128727 0
6 Sundercombe Street, Osborne Park, WA 6017
Country 128727 0
Australia
Phone 128727 0
+61 0418 246 134
Fax 128727 0
Email 128727 0
[email protected]
Contact person for scientific queries
Name 128728 0
Tanya Davison
Address 128728 0
Silverchain, Level 27, 385 Bourke Street, Melbourne, VIC 3000
Country 128728 0
Australia
Phone 128728 0
+61 0408 394 218
Fax 128728 0
Email 128728 0
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20562Study protocol  [email protected]
20563Statistical analysis plan  [email protected]
20564Ethical approval  [email protected]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.