NCT06527625

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 30, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

July 25, 2024

Last Update Submit

September 11, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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).

    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).

    Baseline (T0) and 9 weeks after baseline (T1)

Secondary Outcomes (2)

  • Changes from baseline in empowerment at 9 weeks

    Baseline (T0) and 9 weeks after baseline (T1)

  • Changes from baseline in cognitive fusion at 9 weeks

    Baseline (T0) and 9 weeks after baseline (T1)

Study Arms (2)

Arts group

EXPERIMENTAL

A 9-week Cultural Art Program

Behavioral: Cultural Arts Program

Waitlist control

ACTIVE COMPARATOR

Treatment as usual

Behavioral: Treatment as usual

Interventions

9-session group art program using Chinese calligraphy as the channel for gaining emotional awareness and facilitating expression

Arts group

Treatment as usual provided in local community aged care centres

Waitlist control

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • known history of autism, intellectual disability, schizophrenia-spectrum disorder, bipolar disorder, Parkinson's disease, or dementia;
  • illiterate;
  • physically frail; or
  • significant suicidal risk.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

DepressionAgeism

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPrejudiceSocial BehaviorSocial Discrimination

Study Officials

  • Tianyin Liu, PhD

    The Polytechnic University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 25, 2024

First Posted

July 30, 2024

Study Start

January 1, 2024

Primary Completion

December 31, 2024

Study Completion

June 30, 2025

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations