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临床试验/NCT06527625
NCT06527625已完成不适用

Cultural Arts for Reducing Depressive Symptoms and Age-related Self-stigma in Older People: a Randomised Waitlist Controlled Trial

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
63
试验地点
1
主要终点
Changes from baseline in depressive symptoms at 9 weeks

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Changes from baseline in depressive symptoms at 9 weeks

时间窗: 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

时间窗: 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

时间窗: 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).

Changes from baseline in depressive symptoms at 9 weeks

时间窗: 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

时间窗: 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

时间窗: 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).

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

LIU Tianyin Bridget

Assistant Professor

The Hong Kong Polytechnic University

研究点 (1)

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