A Mind Body Intervention to Reduce Symptoms Among People Aging With HIV

Status Completed

Clinical Trial Summary

This study will develop and pilot test a qigong intervention with older people (50 and over) living with HIV. Participants (n=48) will be randomly assigned to one of 3 conditions: the qigong intervention, a sham qigong intervention, and a usual standard of care group. The study will determine the acceptability and feasibility of the study. If found effective, the qigong intervention will also improve the psychological and physical symptoms of older people living with HIV.

Clinical Trial Description

Half of those infected with HIV in the United States are over 50 years of age; this is expected to increase to 70% by 2020. Yet, few interventions exist for older people living with HIV/AIDS that address psychological symptoms, and none that address physical symptoms, both of which are prevalent in this population. There is a need to find innovative and accessible interventions that can help older people living with HIV/AIDS to manage their symptoms. Mind-body interventions, like Tai chi and Qi gong (TCQ), improves both physical and psychological health, and might also promote immune functioning. TCQ is a series of slow, low-impact meditative movements that integrates breath work, meditation, and stances. The investigators propose the refinement, adaptation, acceptability and feasibility testing of a standardized TCQ intervention shown efficacious with cancer patients, to an ethnically diverse population of older people living with HIV/AIDS, with the goal of enhancing their ability to manage psychological and physical symptoms. Thus, this study proposes three aims: (i) to refine and culturally adapt a TCQ intervention protocol for a diverse sample of older people living with HIV/AIDS (50 years of age or older); (ii) to evaluate the acceptability and feasibility of the TCQ intervention, a sham qigong control condition, and a standard of care control condition for older people living with HIV/AIDS (n = 48); and (iii) explore any preliminary evidence of efficacy of the TCQ intervention and the control conditions on alleviating physical and psychological symptoms. Participants will be recruited from a federally qualified health center in Miami, Florida. Adaptation of the TCQ intervention, the first aim, will be done through qualitative research. An expert panel discussion, key informant interviews, and three focus groups will be conducted, and analyzed by thematically based content analysis. To address aims 2 and 3, the investigators will conduct a pilot study; participants will be randomized to one of 3 conditions: the TCQ intervention, a sham qigong condition, and a standard of care condition. This is a pilot study to assess feasibility, acceptability, and preliminary efficacy, therefore, analyses will be primarily descriptive. The investigators will assess feasibility and acceptability through questionnaires and adherence to TCQ. The investigators will assess preliminary evidence of efficacy by looking at instruments that measure depression, anxiety, social support, as well as clinical outcomes. These will be described through proportions, means, and changes over time through graphing techniques. Outcomes will be assessed at baseline, post-intervention, and at three months follow up. The investigators will conduct preliminary models that will provide information on estimating effect size and power needed for a larger clinical trial. Note: Due to the coronavirus pandemic, this intervention was adapted from an in-person intervention to a virtual intervention. The intervention is exactly the same except for the difference in delivery method. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03840525
Study type	Interventional
Source	Florida International University
Contact
Status	Completed
Phase	Early Phase 1
Start date	January 6, 2020
Completion date	September 30, 2022

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