An interventional study of Tai chi/qigong intervention group and Health Education group in Depressive Symptoms and Hiv, sponsored by Florida International University. Recruiting at 1 site in United States. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Florida International University · Not applicable, Interventional, and Treatment
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/qigong affects depressive symptoms? Does tai chi/qigong affect depressive symptoms among older people living with HIV differently for men compared to women?
Researchers will compare a 12-week, twice a week remotely delivered tai chi/qigong intervention to a health education class of the same duration to determine if it improves depressive symptoms among older people living with HIV.
Participants will:
Attend either a tai chi/qigong class twice a week for 12 weeks or a health education class of the same duration delivered via Zoom. Each class will be 45-60 minutes in length.
Participate in 3 separate interviewer-administered interviews: at the time of enrollment, 3 months after the last class, and 9 months after the last class.
Keep a tracking log of their home practice of tai chi/qigong (only participants in the intervention group).
Use a biosensor (an earlobe sensor or chest strap) to measure their heart variability.
Go to their local lab (e.g., Quest or Labcorp) for blood draw at the time of enrollment and at 9 month post intervention (this will only be a subset of participants).
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 also affect their treatment outcomes. Tai chi/Qigong (TCQ) is a series of slow, low-impact meditative movements that integrate breath work, meditation, and stances; and may improve depressive symptoms. Investigators propose testing the efficacy of a remotely delivered standardized TCQ intervention that has shown to be acceptable and feasible with a population of older people living with HIV/AIDS. Thus, this study proposes three aims: (i) to determine whether a remotely delivered TCQ intervention is directly efficacious in improving depressive symptoms compared to a health education control group among older PWH (50 years of age or older); (ii) to determine whether a remotely delivered TCQ intervention indirectly improves depressive symptoms via biological, psychological, and behavioral mechanisms compared to a health education control group among older PWH and (iii) to determine whether the direct and indirect associations between a TCQ intervention and depressive symptoms is moderated by gender among older PWH. Participants (n=326) will be recruited using social media sites (e.g., WebMD, google, Facebook) throughout the United States. All assessments will be conducted via Zoom videoconferencing or phone. Participants will be randomized to 1 of 2 conditions: the TCQ intervention, or a health education control group condition. Both the TCQ and the health education control condition will be delivered via Zoom to participants in the form of live, synchronous classes. Investigators will assess the efficacy of TCQ by looking at instruments that measure depression; and potential mechanisms such as sleep, fatigue, emotional regulation, and heart variability at baseline, 3-month, and 9-month post-intervention. Blood will also be collected at baseline and at 9-month to collect viral load and an inflammatory marker (C-reactive protein). Data will be described using descriptive techniques.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 326 is above the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →Florida International University is the lead sponsor of 104 studies on the registry; 20 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This is a behavioral intervention that consist of tai chi/qigong group classes via Zoom twice a week for 12 weeks.
Behavioral: Tai chi/qigong intervention 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.
Behavioral: Health Education 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.
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.
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.
Time frame: Depressive symptoms will be assessed at enrollment (or baseline), 3 months post intervention, and 9 months post intervention.
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.
Time frame: The Depression subscale of the DASS-21 will be assessed at enrollment (Baseline), at 3 month and at 9 months after the last class.
Plan to share: Yes — All data will be electronic and stored in an open repository. Data include behavioral, psychological, and biological data collected at three different time points: baseline, 3 month and 9 month post intervention. This also includes the heart rate variability and blood collection results.
Supporting information: Study protocol
Time frame: Data collected at baseline will be made available within 6 months of all baseline data being collected. Data collected at 3 month and 9 month post intervention will be made available 6 months after all data at that time point is collected.
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