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

NCT06586619 | Recruiting DMC

• 2 other identifiers: 8000191071R01AT012590-01A1
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 1

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).

Conditions

Depressive Symptoms; Hiv

Keywords

Depression; HIV; older; tai chi; mindfulness; intervention

Outcome Measures

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.

  Depressive symptoms will be assessed at enrollment (or baseline), 3 months post intervention, and 9 months post intervention.

Secondary Outcomes (1)

• 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.

Study Arms (2)

Tai chi/qigong group

EXPERIMENTAL

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

Health education group

ACTIVE COMPARATOR

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

Interventions

Tai chi/qigong intervention group 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.

Tai chi/qigong group

Health Education group 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.

Health education group

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• 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),
• Must have reliable internet access,
• Must have a smart phone
• No substantial experience (regular weekly practice for more than 3 months in the past 12 months) with mind-body interventions,
• Willing to participate for the length of the 12-week intervention and follow up assessments (a total of 12 months).
• Must report stable housing for the past 60 days and the next 60 days;
• Must have mild to moderate depressive symptoms (a score more than 5 but less than 19 on the PHQ-9 scale)
• Must speak and understand English

You may not qualify if:

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

Sponsors & Collaborators

• Florida International University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Arizona State University: collaborator
• University of Miami: collaborator
• New College of Florida: collaborator

Study Sites (1)

Florida International University

Miami, Florida, 33199, United States

RECRUITING

MeSH Terms

Conditions

Depression; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Gladys E Ibanez, Ph.D.

  Florida International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gladys E Ibanez, Ph.D.

CONTACT

305-348-4920; gibanez@fiu.edu

Adam Carrico, Ph.D.

CONTACT

acarrico@fiu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: August 4, 2025
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)