Clinical trial NCT06586619: A Remotely Delivered Tai Chi/Qigong Intervention for Older People Living With HIV
Official title: A Remotely Delivered Tai Chi/Qigong Intervention for Older People Living With HIV: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depressive Symptoms
Hiv
Keywords: Depression
HIV
older
tai chi
mindfulness
intervention
Lead sponsor: Florida International University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: Arizona State University
name: New College of Florida
name: University of Miami
First posted: 2024-09-19
Enrollment: 326
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Depressive Symptoms
timeFrame: Depressive symptoms will be assessed at enrollment (or baseline), 3 months post intervention, and 9 months post intervention.
Secondary outcomes:
measure: Depressive symptoms
timeFrame: The Depression subscale of the DASS-21 will be assessed at enrollment (Baseline), at 3 month and at 9 months after the last class.
Other outcomes:
Locations:
Study officials:
affiliation: Florida International University
name: Gladys E Ibanez, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: