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临床试验 NCT06586619 针对抑郁症状,人类免疫缺陷病毒 (HIV)目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情,或在此提出任何问题。
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A Remotely Delivered Tai Chi/Qigong Intervention for Older People Living With HIV 326 随机化 远程参与

招募中
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临床试验NCT06586619是一项针对抑郁症状,人类免疫缺陷病毒 (HIV)干预性研究试验,目前试验状态为招募中。试验始于2025年8月4日,计划招募326名患者。该研究由佛罗里达国际大学主导,预计于2029年5月1日完成。试验数据来源于ClinicalTrials.gov,最后更新时间为2025年9月8日
简要概括
The goal of this randomized clinical trial is to learn if tai chi/qigong decreases depressive symptoms among older people living with HIV compared to a health education class. The main questions it aims to answer are:

Does tai chi/qigong reduce depressive symptoms among older people living with HIV more than a health education class? What are the behavioral, psychological, and biological mechanisms in which tai chi/...

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详细描述
Half of those living with HIV in the United States are over 50 years of age. As people living with HIV (PWH) live longer with the disease, the tradeoff is that they live with multiple comorbidities. One of the more common comorbidities is depression. There is a need to find innovative and accessible nonpharmacological interventions that can help older people living with HIV/AIDS to manage depressive symptoms that may...显示更多
官方标题

A Remotely Delivered Tai Chi/Qigong Intervention for Older People Living With HIV: A Randomized Clinical Trial

疾病
抑郁症状人类免疫缺陷病毒 (HIV)
其他研究标识符
NCT编号
实际开始日期
2025-08-04
最近更新发布
2025-09-08
预计完成日期
2029-05
计划入组人数
326
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
招募中
关键词
Depression
HIV
older
tai chi
mindfulness
intervention
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
双盲
试验组/干预措施
参与者组/试验组干预措施/治疗方法
实验性Tai chi/qigong group
This is a behavioral intervention that consist of tai chi/qigong group classes via Zoom twice a week for 12 weeks.
Tai chi/qigong intervention group
The intervention is a tai chi/qigong intervention for older people living with HIV. This behavioral group-based intervention will be delivered through Zoom twice a week for 12 weeks. Each class lasts 45-60 minutes. Tai chi/qigong is a slow low impact meditative movement.
阳性对照Health education group
This is a general health education control group class that will also be delivered via Zoom and will be twice a week for 12 weeks.
Health Education group
Participants will be assigned to a health and wellness education group for older people living with HIV. This group will be delivered through Zoom twice a week for 12 weeks, and each class will last 45-60 minutes. Each group will learn about and discuss a health and wellness topic.
主要终点
结果指标度量标准描述时间框架
Depressive Symptoms
The 10-item Center for Epidemiologic Studies Depression Scale (CES-D) Short form will be used to assess depressive symptoms. Responses refer to the past week and range from: Rarely or none of the time (less than 1 day) = 0 to Most or all of the time (5-7 days) = 3. Scores range from 0-30 with greater scores meaning more depressive symptoms.
Depressive symptoms will be assessed at enrollment (or baseline), 3 months post intervention, and 9 months post intervention.
次要终点
结果指标度量标准描述时间框架
Depressive symptoms
Depressive symptoms will also be assessed using the Depression subscale from the Depression, Anxiety, Stress Scale (DASS-21). Responses refer to the past week and range from: Never=0 to Almost always=3. Higher scores mean more depressive symptoms.
The Depression subscale of the DASS-21 will be assessed at enrollment (Baseline), at 3 month and at 9 months after the last class.
参与助手
资格标准

适龄参与研究
成人, 老年人
最低年龄要求
50 Years
适龄性别
全部

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  1. The ability to provide consent assessed by the GAIN Cognitive Impairment Scale
  2. Provision of signed and dated informed consent form
  3. Must be 50 - 75 years old.
  4. Must have been diagnosed with HIV by a healthcare professional (status confirmed at baseline by an uploaded picture of a recent lab report or medication bottle with name),
  5. Must have reliable internet access,
  6. Must have a smart phone
  7. No substantial experience (regular weekly practice for more than 3 months in the past 12 months) with mind-body interventions,
  8. Willing to participate for the length of the 12-week intervention and follow up assessments (a total of 12 months).
  9. Must report stable housing for the past 60 days and the next 60 days;
  10. Must have mild to moderate depressive symptoms (a score more than 5 but less than 19 on the PHQ-9 scale)
  11. Must speak and understand English

An individual who meets any of the following criteria will be excluded from participation in this study:

  1. Reports high risk for suicide based on the CCSR screening tool.
  2. Has participated in a study on mental health in the last 12 months.
  3. Currently exercising at least 150 minutes a week
Florida International University logo佛罗里达国际大学
研究责任方
Gladys Ibanez, PhD, 主要研究者, Associate Professor, Florida International University
研究中心联系人
联系人: Gladys E Ibanez, Ph.D., 305-348-4920, [email protected]
联系人: Adam Carrico, Ph.D., [email protected]
1 位于 1 个国家/地区的研究中心

Florida

Florida International University, Miami, Florida, 33199, United States
Gladys Ibanez, 联系人, 305-348-4920, [email protected]
招募中