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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03593889
Other study ID # EA1709021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2017
Est. completion date April 30, 2022

Study information

Verified date May 2022
Source The University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To develop a viable and sustainable best practice model to promote elderly mental wellness and prevent elderly depression for Hong Kong, the Hong Kong Jockey Club Charities Trust has initiated a pilot holistic support project entitled "JC JoyAge: Holistic Support Project for Elderly Mental Wellness". Commenced in October 2016, this 3-year project will deliver six programmes: (1) social services staff training; (2) peer supporters certificate training; (3) outreach and engagement activities for at-risk older adults; (4) standardized prevention and early intervention service; (5) community education programmes; and (6) public awareness and public education activities in four pilot districts in Hong Kong, namely Kwun Tong, Sham Shui Po, Kwai Chung, and Tseung Kwan O. The project aims specifically to: 1. Evaluate the effectiveness of a collaborative stepped care and peer support programme in engaging older people at-risk of or with depression; 2. Evaluate the efficacy of the programme in reducing symptoms/risks and promoting wellbeing in older people at-risk of or with depression; 3. Investigate the impact of the programme on care resources utilization in these older adults.


Description:

Elderly depression is a neglected problem affecting our entire society with grave consequences and high societal costs. Early intervention and prevention can be effective in addressing the problem. The challenges in implementing early intervention and prevention within the existing service platforms, however, are threefold: (1) fragmented services; (2) reactive services; and (3) stigma and low awareness. These challenges resulted in the current service overload and mismatch, which will be compounded by rapid population ageing and mental health workforce shrinkage. The study can address these challenges by (1) realigning existing mental health and elderly services; (2) productive ageing for outreach and engagement; and (3) building up capacity of a preventive network in the neighbourhood. This pilot project therefore combines models of collaborative stepped care and productive ageing, with systematic education programmes, to empower the neighbourhood in providing effective early intervention and prevention for elderly depression. In the four representative pilot districts of Kwun Tong, Sham Shui Po, Kwai Chung, and Tseung Kwan O, community mental health and elderly services will collaborate to deliver a stepped care service protocol for preventing and detecting elderly depression. In 3 years, this project will deliver six programmes: (1) social services staff training; (2) peer supporters certificate training; (3) outreach and engagement activities for at-risk older adults; (4) standardized prevention and early intervention service; (5) community education programmes; and (6) public awareness and public education activities. This will produce a mature service model tested in one-fifth of the districts in Hong Kong with different demographic and service characteristics; create a strong team of Peer Supporters and Social Workers in Elderly Mental Health with clinical competence in preventing elderly depression and promoting elderly mental wellness; significantly raise public and neighbourhood awareness and care for elderly mental wellness; reach out and serve 2,880 at-risk older adults and 960 depressed older adults; and provide evidence on the social impact of the model for further service rollout.


Recruitment information / eligibility

Status Completed
Enrollment 3702
Est. completion date April 30, 2022
Est. primary completion date December 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria: - residing in Kwun Tong, Kwai Chung, Tseung Kwan O, or Sham Shui Po; and - have one or more known risk factor(s) for developing depression; and/or - have depressive symptoms of mild level or above; and - able to give informed consent to participate Exclusion Criteria: - known history of autism, intellectual disability, schizophrenia-spectrum disorder, bipolar disorder, Parkinson's disease, or dementia; and - imminent suicidal risk; and - difficulty in communication

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Collaborative stepped care and peer support programme
For "at-risk" group, 4 weeks of "selective prevention" group sessions will be provided at the elderly service level by trained peer supporters with registered social worker supervision, on wellness topics tailored to the person's concern as entry point, packaged with mental health information, followed by a review. For mild group, 6-8 weeks of indicated prevention with psychoeducation or low-intensity psychotherapy would be provided. For moderate group, 6-8 weeks high-intensity cognitive behavioral therapy (CBT) would be provided. All intervention for depressed elderly would be conducted by registered social workers. The trained peer supporters will be matched to individual older adults to walk them through the process with regular follow-up for 1 year.
Other:
Treatment as usual
The control group will receive treatment as usual, which will be determined by the responsible workers from NGO units.

Locations

Country Name City State
Hong Kong Hong Kong Sheng Kung Hui Lady MacLehose Centre Kwai Chung
Hong Kong New Life Psychiatric Rehabilitation Association Kwai Chung
Hong Kong Christian Family Service Centre Kwun Tong
Hong Kong The Mental Health Association of Hong Kong Kwun Tong
Hong Kong Caritas Hong Kong Sham Shui Po
Hong Kong New Life Psychiatric Rehabilitation Association Sham Shui Po
Hong Kong Christian Family Service Centre Tseung Kwan O
Hong Kong Haven of Hope Christian Service Tseung Kwan O

Sponsors (8)

Lead Sponsor Collaborator
The University of Hong Kong Caritas Medical Centre, Hong Kong, Christian Family Service Centre, Haven of Hope Christian Service, Hong Kong Sheng Kung Hui Lady MacLehose Centre, New Life Psychiatric Rehabilitation Association, The Hong Kong Jockey Club Charities Trust, The Mental Health Association of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline depression at 12 months Depression will be measured by the Patient Health Questionnaire (PHQ-9). The total score will be used, ranging from 0 to 27. Higher scores indicate higher levels of depressive symptoms. Baseline and 12-month follow-up
Secondary Change from baseline loneliness at 12 months Loneliness will be measured by the UCLA loneliness scale (UCLA-3). The total score will be used, ranging from 0 to 9. Higher scores indicate greater loneliness. Baseline and 12-month follow-up
Secondary Change from baseline life engagement at 12 months Life engagement will be assessed using the typical day interview - a semi-structured interview asking clients about their typical day activities Baseline and 12-month follow-up
Secondary Change from baseline self-harm risk at 12 months Self-harm risk will be measured by the self-harm risk assessment checklist. Baseline and 12-month follow-up
Secondary Change from baseline anxiety at 12 months Anxiety will be measured by the Generalized Anxiety Disorder scale (GAD-7). The total score will be used, ranging from 0 to 21. Higher scores indicate higher levels of anxiety symptoms. Baseline and 12-month follow-up
Secondary Change from baseline cognitive function at 12 months Cognitive function will be measured by the Hong Kong Montreal Cognitive Assessment 5-Minute Protocol (HK-MoCA 5-Min). The total score will be used, ranging from 0 to 30. Higher scores indicate higher levels of cognitive function. Baseline and 12-month follow-up
Secondary Change from baseline social capital at 12 months Participants will be asked to list out names of people who they would turn to when they feel down, and when they need help for trivial things. Baseline and 12-month follow-up
Secondary Change from baseline health-related quality of life at 12 months Health-related quality of life will be measured by the EuroQoL 5 Dimensions 5 Levels (EQ-5D-5L). Baseline and 12-month follow-up
Secondary Change from baseline service utilization at 12 months Service utilization will be measured by the Client Service Receipt Inventory (CSRI). Baseline and 12-month follow-up
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