【ChiCTR2400087923】The efficacy of an online exercise intervention for improving depressive symptoms among patients with subthreshold depression in primary care: a randomized controlled trial

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基本信息

登记号

ChiCTR2400087923

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

2024-08-07

临床申请受理号

靶点

适应症

Subthreshold depression

试验通俗题目

The efficacy of an online exercise intervention for improving depressive symptoms among patients with subthreshold depression in primary care: a randomized controlled trial

试验专业题目

The efficacy of an online exercise intervention for improving depressive symptoms among patients with subthreshold depression in primary care: a randomized controlled trial

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临床试验信息

试验目的

1. Examine the effectiveness of a 12-week online instructor-led exercise intervention (EIM) when compared to usual care control in reducing depressive symptoms among people with subthreshold depression in primary care 2. Examine the effectiveness of a 12-week online instructor-led exercise intervention (EIM) when compared to usual care control in reducing anxiety symptoms and improving quality of life among people with subthreshold depression in primary care

试验分类

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试验类型

随机平行对照

试验分期

探索性研究/预试验

随机化

Stratified block randomization with random block sizes will be used to enhance balance of gender, anxiety symptoms and level of physical activity at baseline between two arms. The randomisation sequence will be generated by an experienced independent statistician using Random Allocation Software. The sealed randomization code will be stored safely and will be inaccessible to any person involved in the study. The randomization number will not be decoded until the participant is assigned to its corresponding randomization number.

盲法

The allocation is concealed from the researchers, research assistants or coordinators who carry out the baseline assessment or recorded the data, and the statistician who carries out the analysis.

试验项目经费来源

Health Services Research Fund

试验范围

目标入组人数

130

实际入组人数

第一例入组时间

2024-07-01

试验终止时间

2027-07-01

是否属于一致性

入选标准

The inclusion criteria for this study are 1) aged 18 years or above; 2) screened by the Patient Health Questionnaire depression scale (PHQ-9) with results categorized as subthreshold depression, major depression or no depression.；

排除标准

The exclusion criteria are 1) dysthymia with subthreshold depressive symptoms that last for 2 years or more; 2) major depression within the past 6 months, lifetime history of psychosis, schizophrenia and bipolar affective disorder, alcohol or substance abuse, presence of serious suicidal risk and medical illness with a prognosis of less than 6 months to live; 3) patients who are taking antidepressants need to be taking the same medications for more than 3 months with good compliance to be eligible to enroll. 4) patients currently enrolled in any form of psychological interventions for any depressive disorders or symptoms and 5) the presence of physical conditions and include the presence of recently diagnosed or uncontrolled cardiovascular diseases or uncontrolled hypertension, metabolic, vascular or neurological conditions.；

研究者信息

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试验机构

Joint Chinese University of Hong Kong

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