【ChiCTR2300069856】Effects of Behavioural Activation With Mindfulness and Physical Exercise (BAMPE) on Mental Health: A Randomized Controlled Trial

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基本信息

登记号

ChiCTR2300069856

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2023-03-28

临床申请受理号

靶点

适应症

Depression and Anxiety

试验通俗题目

Effects of Behavioural Activation With Mindfulness and Physical Exercise (BAMPE) on Mental Health: A Randomized Controlled Trial

试验专业题目

Effects of Behavioural Activation With Mindfulness and Physical Exercise (BAMPE) on Mental Health: A Randomized Controlled Trial

申办单位信息

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联系人邮编

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临床试验信息

试验目的

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

试验分类

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试验类型

随机平行对照

试验分期

其它

随机化

Cluster randomization will be conducted. A statistician independent of the trial will conduct randomization for each included community centre using a computer program on a 1:1:1 ratio, considering factors like districts and social economic status of the areas where the elderly centres locate.

盲法

The statistician who conducts the data analysis will be blinded to the grouping. But due to the nature of the intervention, staff, interventionalists and participants will not be blinded to the grouping.

试验项目经费来源

The Hong Kong Jockey Club Charities Trust, HKSAR

试验范围

目标入组人数

117

实际入组人数

第一例入组时间

2023-04-01

试验终止时间

2025-07-31

是否属于一致性

入选标准

Inclusion criteria: - 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

Exclusion criteria: - 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；

研究者信息

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试验机构

JC School of Public Health and Primary Care, The Chinese University of Hong Kong

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