Collaborative Stepped-Care and Productive Ageing Program for Older People With Depressive Symptoms

Study at a glance

From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

Evaluation Study of a Collaborative Stepped-Care and Productive Ageing Model for Elderly Mental Wellness in Hong Kong

ClinicalTrials.gov ID

NCT04863300

Acronym / sponsor ID

JCJoyAge2 / EA2003001

Conditions

Depressive Symptoms

Keywords

Collaborative stepped care, Peer support, Productive ageing, Early case identification, Indicated prevention, Early treatment, Recovery oriented

Study type

Interventional

Recruitment status

Completed

Enrolment

5,239 participants (actual)

Lead sponsor

The University of Hong KongUniversity, hospital or other

Collaborators

Aberdeen Kai-fong Welfare Association, Caritas Medical Centre, Hong Kong, Christian Family Service Centre, Haven of Hope Hospital, Hong Kong Christian Service, Hong Kong Sheng Kung Hui Lady MacLehose Centre, Hong Kong Sheng Kung Hui Welfare Council Limited, Hong Kong Young Women's Christian Association, New Life Psychiatric Rehabilitation Association, St. James' Settlement, The Hong Kong Society for the Aged, The Mental Health Association of Hong Kong, Neighbourhood Advice-Action Council, Tung Wah Group of Hospitals

Study start

1 Jan 2020 (actual)

Primary completion

31 Dec 2023 (actual)

Study completion

30 Jun 2024 (actual)

First posted

28 Apr 2021 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Prevention

Allocation

Not applicable

Intervention model

Single group

Masking

None (open label)

Number of arms

1

Model description

The intervention group will receive a collaborative stepped care programme provided by registered social workers and trained peer supporters from two types of NGOs (aged care or mental health service units) according to level of risks, symptom severity, and intervention response of the clients. Home visits or other format of contact will be delivered by trained peer supporters employed by NGOs to detect and engage hidden cases.

Who may qualify

Ages

60 years and older

Sex

All

Healthy volunteers

Accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Change from Baseline Depression at 12 months

   Time frame: Baseline and 12-month follow-up

   Depression will be measured by the Patient Health Questionnaire (PHQ-9), a 9-item instrument that incorporates depression diagnostic criteria with other leading major depressive symptoms, and rates the frequency of the symptoms that factor into the scoring severity index. PHQ-9 total score ranges from 0 to 27, higher scores indicate higher levels of depression. Change scores of depression will be calculated by subtract the baseline PHQ-9 score from the follow-up PHQ-9 score, and negative results indicates reduction in depression.

2. Change from Baseline Anxiety at 12 months

   Time frame: Baseline and 12-month follow-up

   Anxiety will be measured by the Generalized Anxiety Disorder scale (GAD-7), a 7-item scale in which responses to each item are rated on a 4-point Likert scale ranging from 0 to 3. The total score will be used, ranging from 0 to 21. Higher scores indicate higher levels of anxiety symptoms. Change scores of anxiety will be calculated by subtract the baseline GAD-7 score from the follow-up GAD-7 score, and negative results indicates reduction in anxiety.

3. Change from Baseline Loneliness at 12 months

   Time frame: Baseline and 12-month follow-up

   Loneliness will be measured by the UCLA loneliness scale (UCLA-3), a 3-item self-report scale with each item evaluated with scores ranging from 0 (never) to 3 (often). The total score will be used, ranging from 0 to 9. Higher scores indicate greater loneliness. Change scores of loneliness will be calculated by subtract the baseline UCLA-3 score from the follow-up UCLA-3 score, and negative results indicates reduction in loneliness.

4. Change from Baseline Self-harm Risk at 12 months

   Time frame: Baseline and 12-month follow-up

   Self-harm risk will be assessed using eight items adapted from the Self-Harm Inventory, providing an overall assessment based on total score and clinical judgement. Social service staff assess participants' risk of self-harm (yes or no answers to 10 items) and harm to others (yes or no answers to 4 items). An overall evaluation of suicidal risk score ranges from 0 (No) to 3 (High). The overall evaluation score will be used. Change scores of self-harm risk will be calculated by subtract the baseline overall risk score from the follow-up risk score, and negative results indicates reduction in self-harm risk.

5. Change from Baseline Service Usage at 12 months

   Time frame: Baseline and 12-month follow-up

   Client Service Receipt Inventory (CSRI) will be used to collect the current types and level of social services which comprise the care package of each participant, and a locally adapted short version would be developed for this purpose. Participants report frequency of usage of different services in the past month when filling the questionnaire, higher frequency indicates more usage of that particular service.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
• Derived from this study: PubMed 39574082Wong SMY, Leung DKY, Liu T, Ng ZLY, Wong GHY, Chan WC, Lum TYS. Comorbid anxiety, loneliness, and chronic pain as predictors of intervention outcomes for subclinical depressive symptoms in older adults: evidence from a large community-based study in Hong Kong. BMC Psychiatry. 2024 Nov 21;24(1):839. doi: 10.1186/s12888-024-06281-2.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

43 sites in 1 country: see every site and its status.