A Remotely Delivered Tai Chi/Qigong Intervention for Older People Living With HIV
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-75
SponsorFlorida International University
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The ability to provide consent assessed by the GAIN Cognitive Impairment Scale
Provision of signed and dated informed consent form
Must be 50 - 75 years old.
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),
Disqualifiers
Reports high risk for suicide based on the CCSR screening tool.
Has participated in a study on mental health in the last 12 months.
Currently exercising at least 150 minutes a week
Trial design
Design model
Parallel
Treatments tested in this trial
Tai chi/qigong intervention group
BehavioralThe 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.
Health Education group
BehavioralParticipants 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.
Treatment groups
326 Participants
are divided into 2 treatment groupsGroup A: Tai chi/qigong groupExperimental treatment 1 intervention
Group B: Health education groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Florida International University
Lead sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Arizona State University
Collaborator
University of Miami
Collaborator
New College of Florida
Collaborator
Source ClinicalTrials.gov