A Remotely Delivered Tai Chi/Qigong Intervention for Older People Living With HIV

NCT ID: NCT06586619

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 326 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-04
• Study Completion Date: 2029-05-31

Brief Summary

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).

Detailed Description

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.

Conditions

Depressive Symptoms; Hiv

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Tai chi/qigong intervention group

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Health Education group

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Arizona State University

OTHER

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: collaborator

New College of Florida

UNKNOWN

Sponsor Role: collaborator

Florida International University

OTHER

Sponsor Role: lead

Responsible Party

Gladys Ibanez, PhD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gladys E Ibanez, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Florida International University

Locations

Florida International University

Miami, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Gladys E Ibanez, Ph.D.

Role: CONTACT

gibanez@fiu.edu

305-348-4920

Adam Carrico, Ph.D.

Role: CONTACT

acarrico@fiu.edu

Facility Contacts

Gladys Ibanez

Role: primary

gibanez@fiu.edu

305-348-4920

Other Identifiers

1R01AT012590-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

800019107

Identifier Type: -

Identifier Source: org_study_id