ChiCTR2300069856尚未招募Unknown
Effects of Behavioural Activation With Mindfulness and Physical Exercise (BAMPE) on Mental Health: A Randomized Controlled Trial
The Hong Kong Jockey Club Charities Trust, HKSAR1 个研究点 分布在 1 个国家开始时间: 2023年4月1日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 试验地点
- 1
- 主要终点
- depression and anxiety symptoms (measured by the PHQ-9 and GAD-7 )
研究概览
简要总结
We propose to conduct a randomized controlled trial to understand the effects and acceptability of behavioural activation with mindfulness and physical activity (BAMPE) among community dwelling older adults in reducing their depression and anxiety, when compared to usual care and PE, separately. The primary objective is to:
- examine the effects of BAMPE on reducing depression and anxiety symptoms, when compared to usual care at 2 months The secondary objectives are to:
- examine the effects of BAMPE on reducing depression and anxiety symptoms, and loneliness, when compared to PE
- examine the changes in health-related quality of life and physical activity level, when compared to usual care or PE
- examine the effects of BAMPE on reducing healthcare utilization, when compared to usual care or PE
- examine the acceptability and compliance of BAMPE, when compared to PE
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
- 盲法
- None
入排标准
- 年龄范围
- 60 至 100（—）
- 性别
- All
入选标准
- •Aged 60 years or above
- •PHQ-2 or GAD-2 score ≥3 (screening positive for depression or anxiety)
- •ability to speak Cantonese
排除标准
- •major depression within the past 6 months
- •lifetime history of other psychiatric disorders with psychotic features (psychosis, schizophrenia, or bipolar affective disorder);
- •alcohol or substance abuse;
- •presence of serious suicidal risk;
- •medical illness with a prognosis of fewer than 6 months to live;
- •receiving current psychiatric treatments with medication changes in the past 6 months
- •inability to read or write.
- •has participated in a structured mindfulness-based programme in the past 1 year
研究组 & 干预措施
Intervention Group
Control Group
结局指标
主要结局
depression and anxiety symptoms (measured by the PHQ-9 and GAD-7 )
时间窗: at 0, 2 months (post intervention, primary time point for outcome measures), 5 months (3 months post intervention).
次要结局
- acceptability of the intervention (measured by compliance to the intervention and satisfaction with the intervention),(at 0, 2 months (post intervention, primary time point for outcome measures), 5 months (3 months post intervention).)
- loneliness level (measured by the validated UCLA 3-Item Loneliness Scale (UCLA-3))(at 0, 2 months (post intervention, primary time point for outcome measures), 5 months (3 months post intervention).)
- physical activity level (measured by the validated Chinese version of the Physical Activity Scale for the Elderly (PASE)(at 0, 2 months (post intervention, primary time point for outcome measures), 5 months (3 months post intervention).)
- psychological flexibility (measured by the validated Brief Experiential Avoidance Questionnaire (BEAQ), Multidimensional psychological flexibility inventory 24-item(MPFI-24)(at 0, 2 months (post intervention, primary time point for outcome measures), 5 months (3 months post intervention).)
- health-related quality of life (measured by the validated 5-item EQ-5D-5L, World Health Organization Quality of Life questionnaire (WHOQOL-Bref))(at 0, 2 months (post intervention, primary time point for outcome measures), 5 months (3 months post intervention).)
- health service utilization including GOPC visits, hospitalization, and accident and emergency departments (AED) admission in the public sector within the study period. Visits to private clinics will be assessed by a self-reported questionnaire. Besides, basic information (e.g., age, sex, education, occupation, reception of soc(at 0, 2 months (post intervention, primary time point for outcome measures), 5 months (3 months post intervention).)
研究者
研究点 (1)
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