Depressive SymptomsNCT06527625
Cultural Arts Programme for Older Chinese
A study testing Cultural Arts Program and Treatment as usual in people with Depressive Symptoms and Ageism, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
This study examines the effectiveness of an innovative cultural arts program in reducing depressive symptoms and age-related self-stigma among older Chinese as compared to service as usual through a randomized waitlist controlled trial. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depressive Symptoms, Ageism, Older Adults
- What is being tested?
- Cultural Arts Program and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 60 years or above;
- at risk for depression, i.e., Patient Health Questionnaire (PHQ-9) score under 10; or
- having at least one risk factor of depression, including frequent loneliness, lack of social interaction, lack of meaningful/enjoyable activities, chronic pain, more than four chronic diseases, or bereavement.
Who cannot join
- known history of autism, intellectual disability, schizophrenia-spectrum disorder, bipolar disorder, Parkinson's disease, or dementia;
- illiterate;
- physically frail; or
- significant suicidal risk.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cultural Arts for Reducing Depressive Symptoms and Age-related Self-stigma in Older People: a Randomised Waitlist Controlled Trial
This study examines the effectiveness of an innovative cultural arts program in reducing depressive symptoms and age-related self-stigma among older Chinese as compared to service as usual through a randomized waitlist controlled trial.
Read the detailed description
Depressive symptoms are common among community-dwelling older people, and prevention and early detection can reduce the incidence of depressive disorders. However, internalized ageism and stigma of mental illness may disempower older people and impede help-seeking behaviors among those at risk of depression. Nonpharmacological interventions may reduce stigma, and among different approaches, arts-based programs are gaining attention because arts are deemed enjoyable, stigma-free, and conducive to mental health.
This study adopts a waitlist-controlled trial and examines the effectiveness of an innovative cultural art programme to combat internalised ageism and reduce depressive symptoms compared with service as usual. Community-dwelling older adults (age 60 years and over) at risk for depression will be recruited and randomised to receive cultural arts (experimental group) or service as usual (waitlist control group). Assessments will be administered by trained researcher(s) at baseline (T0), and completion of the 9-session intervention (T1). Effectiveness analyses will be based on changes in assessments at different time points between intervention and control groups.
- Conditions
- Depressive Symptoms, Ageism, Older Adults, Psychosocial Intervention, Art
- Being tested
- Cultural Arts Program, Treatment as usual
- Medical subject headings
- Depression, Ageism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cultural Arts ProgramBehavioural
9-session group art program using Chinese calligraphy as the channel for gaining emotional awareness and facilitating expression
Treatment as usualBehavioural
Treatment as usual provided in local community aged care centres
| Study group | Role | What they receive |
|---|---|---|
| Arts group | Experimental | A 9-week Cultural Art Program Receives: Behavioral: Cultural Arts Program |
| Waitlist control | Active comparator | Treatment as usual Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in depressive symptoms at 9 weeks
Depressive symptoms are assessed using the Patient Health Questionnaire (PHQ-9) (Kroenke et al., 2001). It is a 9-item instrument that incorporates depression diagnostic criteria with other leading major depressive symptoms and rates the frequency of the symptoms, factoring into the scoring severity index. PHQ-9 scores of 5-9, 10-14, 15-19, 20 and above represent mild, moderate, moderately severe, and severe depression, respectively.
Measured: Baseline (T0) and 9 weeks after baseline (T1)
Changes from baseline in self-stigma of age at 9 weeks
Self-stigma of age is assessed by the Internalized Stigma of old age scale (IS65+) (González-Domínguez et al., 2018). The IS65+ scale is a 9-item instrument comprised of five factors: alienation, discrimination experience, social withdrawal, stigma resistance, and stereotype endorsement. Participants responded to a 4-point Likert scale ranging from 1 (completely disagree) to 4 (completely agree), and a higher score indicates more internalized ageism. The original scale had good internal consistency (α = 0.89).
Measured: Baseline (T0) and 9 weeks after baseline (T1)
Changes from baseline in self-stigma of depression at 9 weeks
Self-stigma of depression is assessed using the 16-item Self-Stigma of Depression Scale (SSDS) (Barney et al., 2006). Questions begin with the stem "If I were depressed, I would …" and include items such as "feel inferior to others" (Shame), "think I should be able to cope with things" (Self-Blame), and "feel I could not contribute much socially" (Social Inadequacy). Participants responded using a 5-point Likert scale of 1 (strongly disagree) to 5 (strongly agree). A higher score indicates more self-stigma of depression, and the scale has good construct validity, internal consistency (α = 0.87) and satisfactory test-retest reliability (Cohen's d = 0.17).
Measured: Baseline (T0) and 9 weeks after baseline (T1)
Secondary outcomes (2)
Changes from baseline in empowerment at 9 weeks
Empowerment is measured by the self-empowerment subscale (SES, four items) from the Mental Health Recovery Measure (MHRM) (Young \& Bullock, 2003). Items are rated on a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree); higher scores indicate a higher self-reported level of self-empowerment. Example items include: "I believe in myself" and "I have control over my mental health problems"; a higher score indicates more self-empowered.
Measured: Baseline (T0) and 9 weeks after baseline (T1)
Changes from baseline in cognitive fusion at 9 weeks
Cognitive fusion is measured by the self-report Cognitive Fusion Questionnaire (CFQ) (Gillanders et al., 2014). It is a 7-item Likert-type scale ranging from 1 (never true) to 7 (always true). Example items include: "My thoughts cause me distress or emotional pain" and "I tend to get very entangled in my thoughts." Higher scores indicated higher levels of cognitive fusion in participants, ranging from 7 to 49. The scale was validated in Chinese, with good internal consistency (α = 0.92) and test-retest reliability (r = 0.67) (Zhang et al., 2014).
Measured: Baseline (T0) and 9 weeks after baseline (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2024
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Hong Kong
- Responsible party
- Principal investigator, LIU Tianyin Bridget, The Hong Kong Polytechnic University
- Investigators
- Tianyin Liu, PhD, Principal investigator, The Polytechnic University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527625
- Sponsor's protocol ID
- HSEARS20240227002
- Status last verified
- Sep 2025
- First submitted
- 25 Jul 2024
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cultural Arts for Reducing Depressive Symptoms and Age-related Self-stigma in Older People: a Randomised Waitlist Controlled Trial
- ClinicalTrials.gov ID
- NCT06527625
- Acronym / sponsor ID
- HSEARS20240227002
- Conditions
- Depressive Symptoms, Ageism, Older Adults, Psychosocial Intervention, Art
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- The University of Hong Kong
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 30 Jul 2024 (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.
This study examines the effectiveness of an innovative cultural arts program in reducing depressive symptoms and age-related self-stigma among older Chinese as compared to service as usual through a randomized waitlist controlled trial.
Detailed description
Depressive symptoms are common among community-dwelling older people, and prevention and early detection can reduce the incidence of depressive disorders. However, internalized ageism and stigma of mental illness may disempower older people and impede help-seeking behaviors among those at risk of depression. Nonpharmacological interventions may reduce stigma, and among different approaches, arts-based programs are gaining attention because arts are deemed enjoyable, stigma-free, and conducive to mental health.
This study adopts a waitlist-controlled trial and examines the effectiveness of an innovative cultural art programme to combat internalised ageism and reduce depressive symptoms compared with service as usual. Community-dwelling older adults (age 60 years and over) at risk for depression will be recruited and randomised to receive cultural arts (experimental group) or service as usual (waitlist control group). Assessments will be administered by trained researcher(s) at baseline (T0), and completion of the 9-session intervention (T1). Effectiveness analyses will be based on changes in assessments at different time points between intervention and control groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arts group | Experimental | Behavioral: Cultural Arts ProgramA 9-week Cultural Art Program |
| Waitlist control | Active comparator | Behavioral: Treatment as usualTreatment as usual |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 60 years or above;
- at risk for depression, i.e., Patient Health Questionnaire (PHQ-9) score under 10; or
- having at least one risk factor of depression, including frequent loneliness, lack of social interaction, lack of meaningful/enjoyable activities, chronic pain, more than four chronic diseases, or bereavement.
Key exclusion criteria (4 listed)
- known history of autism, intellectual disability, schizophrenia-spectrum disorder, bipolar disorder, Parkinson's disease, or dementia;
- illiterate;
- physically frail; or
- significant suicidal risk.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cultural Arts Program9-session group art program using Chinese calligraphy as the channel for gaining emotional awareness and facilitating expression | Behavioural | Arts group |
| Treatment as usualTreatment as usual provided in local community aged care centres | Behavioural | Waitlist control |
Primary outcome
Changes from baseline in depressive symptoms at 9 weeks
Time frame: Baseline (T0) and 9 weeks after baseline (T1)
Depressive symptoms are assessed using the Patient Health Questionnaire (PHQ-9) (Kroenke et al., 2001). It is a 9-item instrument that incorporates depression diagnostic criteria with other leading major depressive symptoms and rates the frequency of the symptoms, factoring into the scoring severity index. PHQ-9 scores of 5-9, 10-14, 15-19, 20 and above represent mild, moderate, moderately severe, and severe depression, respectively.
Changes from baseline in self-stigma of age at 9 weeks
Time frame: Baseline (T0) and 9 weeks after baseline (T1)
Self-stigma of age is assessed by the Internalized Stigma of old age scale (IS65+) (González-Domínguez et al., 2018). The IS65+ scale is a 9-item instrument comprised of five factors: alienation, discrimination experience, social withdrawal, stigma resistance, and stereotype endorsement. Participants responded to a 4-point Likert scale ranging from 1 (completely disagree) to 4 (completely agree), and a higher score indicates more internalized ageism. The original scale had good internal consistency (α = 0.89).
Changes from baseline in self-stigma of depression at 9 weeks
Time frame: Baseline (T0) and 9 weeks after baseline (T1)
Self-stigma of depression is assessed using the 16-item Self-Stigma of Depression Scale (SSDS) (Barney et al., 2006). Questions begin with the stem "If I were depressed, I would …" and include items such as "feel inferior to others" (Shame), "think I should be able to cope with things" (Self-Blame), and "feel I could not contribute much socially" (Social Inadequacy). Participants responded using a 5-point Likert scale of 1 (strongly disagree) to 5 (strongly agree). A higher score indicates more self-stigma of depression, and the scale has good construct validity, internal consistency (α = 0.87) and satisfactory test-retest reliability (Cohen's d = 0.17).
2 secondary outcomes
Changes from baseline in empowerment at 9 weeks
Time frame: Baseline (T0) and 9 weeks after baseline (T1)
Changes from baseline in cognitive fusion at 9 weeks
Time frame: Baseline (T0) and 9 weeks after baseline (T1)
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 12 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Tianyin Liu, PhD principal investigator
The Polytechnic University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cultural Arts Program and Treatment as usual in people with Depressive Symptoms and Ageism, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in depressive symptoms at 9 weeks (time frame: Baseline (T0) and 9 weeks after baseline (T1)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.