Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06586619
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
A Remotely Delivered Tai Chiqigong Intervention for Older People Living with HIV
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Remotely Delivered Tai ChiQigong Intervention for Older People Living with HIV a Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this randomized clinical trial is to learn if tai chiqigong 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 chiqigong 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 chiqigong affects depressive symptoms Does tai chiqigong 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 chiqigong 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 chiqigong 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 chiqigong 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 eg 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
Does tai chiqigong 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 chiqigong affects depressive symptoms Does tai chiqigong 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 chiqigong 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 chiqigong 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 chiqigong 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 eg 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 HIVAIDS to manage depressive symptoms that may also affect their treatment outcomes Tai chiQigong 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 HIVAIDS 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 n326 will be recruited using social media sites eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None