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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.

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.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623001345673
Acronym
EMBED Trial
Enrollment
1050
Registered
2023-12-20
Start date
2023-12-20
Completion date
2025-01-31
Last updated
2024-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Older adults who receive aged care services within their own home commonly experience depression. Physical health is often prioritised in this population and mental health concerns can remain overlooked and undertreated. A new mental health model of care, Enhanced Management of home-Based Elders with Depression (EMBED) has been developed to meet the growing need for accessible and tailored psychological care for home aged care recipients. This study aims to evaluate the effectiveness of the EMBED intervention, as well as the costs and benefits of this approach.

Interventions

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

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.

Sponsors

Silverchain
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No

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.

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)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026