A Tripartite Biopsychosocial Intervention Program Enhances Mental Health and Quality of Life in Elderly Patients With Depression Secondary to Geriatric Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Change in Depressive Symptoms Measured by the Hamilton Rating Scale for Depression (HAMD-17)
研究概览
简要总结
The biopsychosocial integrated intervention program is an effective model for improving holistic health in elderly patients with geriatric disease-related secondary depression, significantly alleviating depressive symptoms, enhancing mental health, and elevating quality of life.
详细描述
To investigate the effects of a tripartite biopsychosocial intervention program on mental health and quality of life in elderly patients with depression secondary to geriatric diseases. A cluster randomized controlled trial was conducted with 166 elderly patients with secondary depression in our hospital between January 2022 and January 2025. Wards were randomized into an intervention group (n = 83) and a control group (n = 83) using SPSS-generated random sequences. The intervention group received a biopsychosocial integrated program, while the control group received standard psychiatric care. Outcomes were assessed at baseline, 1, 2, and 3 months post-intervention using the 17-item Hamilton Rating Scale for Depression (HAMD-17), mental health indicators [Profile of Mood States (POMS), Five Facet Mindfulness Questionnaire (FFMQ), and Mental Health Continuum-Short Form (MHC-SF)], and the Generic Quality of Life Inventory-74 (GQOLI-74). Patient satisfaction was evaluated post-intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of depression secondary to geriatric disease (ICD-10 criteria)
- •Age ≥60 years
- •Baseline HAMD-17 score ≥14 (mild depression or worse)
- •Mini-Mental State Examination (MMSE) score ≥24 (no significant cognitive impairment)
- •Willing and able to provide informed consent (patient or guardian)
- •Stable on current medications for ≥4 weeks prior to enrollment
排除标准
- •Primary psychiatric disorders:
- •Schizophrenia or bipolar disorder
- •Severe personality disorders
- •Active suicidal ideation or psychotic symptoms
- •Recent treatment history:
- •Antipsychotic medication within 3 months
- •Electroconvulsive therapy within 6 months
- •Participation in other interventional trials
- •Neurological conditions:
- •Alzheimer's disease or vascular dementia
- •Parkinson's disease with cognitive impairment
- •Brain tumors or traumatic brain injury
- •Medical comorbidities:
- •Terminal illness with life expectancy <6 months
- •Uncontrolled cardiovascular disease
- •Severe hepatic/renal insufficiency (GFR <30 mL/min)
- •Substance abuse disorders (alcohol or drugs within past year)
研究组 & 干预措施
control group
the control group received standard psychiatric care
intervention group
The intervention group received a biopsychosocial integrated program
干预措施: control group (Behavioral)
intervention group
The intervention group received a biopsychosocial integrated program
干预措施: Intervention group (Combination Product)
结局指标
主要结局
Change in Depressive Symptoms Measured by the Hamilton Rating Scale for Depression (HAMD-17)
时间窗: Baseline, 1 month, 2 months, and 3 months post-intervention.
The HAMD-17 is a 17-item clinician-administered scale assessing depressive symptom severity (range: 0-52). Higher scores indicate worse depression. Primary outcome: change in HAMD-17 scores from baseline to 3 months post-intervention.
次要结局
- Mental Health Status (Profile of Mood States, POMS)(Baseline, 1 month, 2 months, and 3 months post-intervention.)
- Mindfulness Skills (Five Facet Mindfulness Questionnaire, FFMQ)(Baseline, 1 month, 2 months, and 3 months post-intervention.)
- Psychological Well-Being (Mental Health Continuum-Short Form, MHC-SF)(Baseline, 1 month, 2 months, and 3 months post-intervention.)
研究者
Yan Chen
Principal Investigator
Wenzhou Seventh People's Hospital