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

Study Overview
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Brief Summary
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This study will develop and pilot test a qigong intervention with older people (50 and over) living with HIV. Participants (n=72) 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.

Detailed Description
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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 = 60); 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.

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

Conditions
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Mental Health, Physical Health

Intervention / Treatment
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* Behavioral: The Qigong Intervention
* Behavioral: Sham Qigong


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 50 year or older; HIV+, able to provide consent; and willing to participate for the length of the intervention. Exclusion criteria. Participants who are unable to stand for 10-minute segments (i.e., wheelchair or walker bound); and participants who have substantial (regular weekly practice for more than 3 months in the past 12 months) experience with mind-body interventions will be excluded because the control group may be contaminated by prior experience.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study will implement a 3 arm study including the qigong intervention, sham qigong intervention, and a treatment as usual condition. The qigong and sham qigong groups will be delivered virtually due to the coronavirus pandemic.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Qigong Intervention<br>The qigong intervention consists of 1 hour/week qigong classes for 12 weeks to be delivered virtually. The first 2 weeks will include 2 hours/week classes. In addition, each participant will be instructed to practice qigong at home for 90 minutes. | Behavioral: The Qigong Intervention<br>* Qigong is a low-impact, slow-movement, meditative form of exercise that has helped relieve mental and physical stressors.<br>|
| Sham Comparator: Sham Qigong<br>This group will also have 1 hour/weekly class delivered virtually that includes movements that are similar to qigong but will not include the meditation or breathwork that will be included in the actual qigong intervention arm. | Behavioral: Sham Qigong<br>* This intervention includes similar body movements to qigong; however, it does not have the meditative or breath work.<br>|
| No Intervention: Treatment-as-usual<br>This group will receive no classes. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with weekly Intervention Sessions | Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction | Assessments will be conducted once in Week 1 | 
| Satisfaction with weekly Intervention Sessions | Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction | Assessments will be conducted once in Week 2 | 
| Satisfaction with weekly Intervention Sessions | Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction | Assessments will be conducted once in Week 3 | 
| Satisfaction with weekly Intervention Sessions | Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction | Assessments will be conducted once in Week 4 | 
| Satisfaction with weekly Intervention Sessions | Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction | Assessments will be conducted once in Week 5 | 
| Satisfaction with weekly Intervention Sessions | Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction | Assessments will be conducted once in Week 6 | 
| Satisfaction with weekly Intervention Sessions | Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction | Assessments will be conducted once in Week 7 | 
| Satisfaction with weekly Intervention Sessions | Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction | Assessments will be conducted once in Week 8 | 
| Satisfaction with weekly Intervention Sessions | Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction | Assessments will be conducted once in Week 9 | 
| Satisfaction with weekly Intervention Sessions | Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction | Assessments will be conducted once in Week 10 | 
| Satisfaction with weekly Intervention Sessions | Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction | Assessments will be conducted once in Week 11 | 
| Satisfaction with weekly Intervention Sessions | Satisfaction will be measured by asking the following questions after each session: How satisfied were you with the group; I think this intervention was helpful; I would be willing to participate in the group again. Responses are on a 4 point Likert scale (1=strongly agree to 4=strongly disagree) with lower scores meaning more satisfaction | Assessments will be conducted once in Week 12 | 
| Satisfaction with weekly home practice sessions | Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction | Assessments will be conducted once in Week 1 | 
| Satisfaction with weekly home practice sessions | Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction | Assessments will be conducted once in Week 2 | 
| Satisfaction with weekly home practice sessions | Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction | Assessments will be conducted once in Week 3 | 
| Satisfaction with weekly home practice sessions | Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction | Assessments will be conducted once in Week 4 | 
| Satisfaction with weekly home practice sessions | Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction | Assessments will be conducted once in Week 5 | 
| Satisfaction with weekly home practice sessions | Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction | Assessments will be conducted once in Week 6 | 
| Satisfaction with weekly home practice sessions | Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction | Assessments will be conducted once in Week 7 | 
| Satisfaction with weekly home practice sessions | Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction | Assessments will be conducted once in Week 8 | 
| Satisfaction with weekly home practice sessions | Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction | Assessments will be conducted once in Week 9 | 
| Satisfaction with weekly home practice sessions | Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction | Assessments will be conducted once in Week 10 | 
| Satisfaction with weekly home practice sessions | Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction | Assessments will be conducted once in Week 11 | 
| Satisfaction with weekly home practice sessions | Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction | Assessments will be conducted once in Week 12 | 
| Satisfaction with home practice sessions at 3 months | Satisfaction will be measured by asking the following question after each session: From 1 to 5, what was your overall satisfaction with the at-home video intervention program? This will be measured on a scale 1 (poor) to 5 (Excellent) with higher scores meaning higher satisfaction | Assessments will be conducted at 3 months post intervention | 
| Intervention Session Attendance (reported as percentages) | The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance). | Assessments will be conducted once at Week 1 | 
| Intervention Session Attendance (reported as percentages) | The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance). | Assessments will be conducted once at Week 2 | 
| Intervention Session Attendance (reported as percentages) | The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance). | Assessments will be conducted once at Week 3 | 
| Intervention Session Attendance (reported as percentages) | The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance). | Assessments will be conducted once at Week 4 | 
| Intervention Session Attendance (reported as percentages) | The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance). | Assessments will be conducted once at Week 5 | 
| Intervention Session Attendance (reported as percentages) | The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance). | Assessments will be conducted once at Week 6 | 
| Intervention Session Attendance (reported as percentages) | The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance). | Assessments will be conducted once at Week 7 | 
| Intervention Session Attendance (reported as percentages) | The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance). | Assessments will be conducted once at Week 8 | 
| Intervention Session Attendance (reported as percentages) | The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance). | Assessments will be conducted once at Week 9 | 
| Intervention Session Attendance (reported as percentages) | The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance). | Assessments will be conducted once at Week 10 | 
| Intervention Session Attendance (reported as percentages) | The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance). | Assessments will be conducted once at Week 11 | 
| Intervention Session Attendance (reported as percentages) | The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance). | Assessments will be conducted once at Week 12 | 
| Duration of weekly home practice sessions | The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes) | Assessments will be conducted once at Week 1 | 
| Duration of weekly home practice sessions | The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes) | Assessments will be conducted once at Week 2 | 
| Duration of weekly home practice sessions | The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes) | Assessments will be conducted once at Week 3 | 
| Duration of weekly home practice sessions | The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes) | Assessments will be conducted once at Week 4 | 
| Duration of weekly home practice sessions | The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes) | Assessments will be conducted once at Week 5 | 
| Duration of weekly home practice sessions | The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes) | Assessments will be conducted once at Week 6 | 
| Duration of weekly home practice sessions | The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes) | Assessments will be conducted once at Week 7 | 
| Duration of weekly home practice sessions | The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes) | Assessments will be conducted once at Week 8 | 
| Duration of weekly home practice sessions | The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes) | Assessments will be conducted once at Week 9 | 
| Duration of weekly home practice sessions | The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes) | Assessments will be conducted once at Week 10 | 
| Duration of weekly home practice sessions | The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes) | Assessments will be conducted once at Week 11 | 
| Duration of weekly home practice sessions | The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes) | Assessments will be conducted once at Week 12 | 
| Duration of home practice sessions at 3 months | The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes) | Assessments will be conducted at 3 months post intervention | 
| Frequency of home practice sessions | The investigators will also collect information on home practice sessions: how often did they practice (# of days/week) | Assessments will be conducted once in Week 1 | 
| Frequency of home practice sessions | The investigators will also collect information on home practice sessions: how often did they practice (# of days/week) | Assessments will be conducted once in Week 2 | 
| Frequency of home practice sessions | The investigators will also collect information on home practice sessions: how often did they practice (# of days/week) | Assessments will be conducted once in Week 3 | 
| Frequency of home practice sessions | The investigators will also collect information on home practice sessions: how often did they practice (# of days/week) | Assessments will be conducted once in Week 4 | 
| Frequency of home practice sessions | The investigators will also collect information on home practice sessions: how often did they practice (# of days/week) | Assessments will be conducted once in Week 5 | 
| Frequency of home practice sessions | The investigators will also collect information on home practice sessions: how often did they practice (# of days/week) | Assessments will be conducted once in Week 6 | 
| Frequency of home practice sessions | The investigators will also collect information on home practice sessions: how often did they practice (# of days/week) | Assessments will be conducted once in Week 7 | 
| Frequency of home practice sessions | The investigators will also collect information on home practice sessions: how often did they practice (# of days/week) | Assessments will be conducted once in Week 8 | 
| Frequency of home practice sessions | The investigators will also collect information on home practice sessions: how often did they practice (# of days/week) | Assessments will be conducted once in Week 9 | 
| Frequency of home practice sessions | The investigators will also collect information on home practice sessions: how often did they practice (# of days/week) | Assessments will be conducted once in Week 10 | 
| Frequency of home practice sessions | The investigators will also collect information on home practice sessions: how often did they practice (# of days/week) | Assessments will be conducted once in Week 11 | 
| Frequency of home practice sessions | The investigators will also collect information on home practice sessions: how often did they practice (# of days/week) | Assessments will be conducted once in Week 12 | 
| Frequency of home practice sessions at 3 months | The investigators will also collect information on home practice sessions: how often did they practice (# of days/week) | Assessments will be conducted at 3 months post intervention | 
| Will older people living with HIV still be practicing the intervention 3 months post intervention? | The investigators will also collect information on home practice sessions: how often did they practice, for how long were each practice session, satisfaction with the video and practice sessions three months post intervention. | Assessments will be conducted at 3 months post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mental Health at 2 weeks post intervention | Mental Health will be assessed using the following standardized scale: the Depression Anxiety & Stress Scale (Ng, et al.; DASS-21 items). The DASS responses range from 0-3. The total score ranges from 0-42, with higher scores reflecting more severe symptoms | Assessments will be conducted at baseline, 2 weeks post intervention | 
| Change in Mental Health at 3 months post intervention | Mental Health will be assessed using the following standardized scale: the Depression Anxiety & Stress Scale (Ng, et al.; DASS-21 items). The DASS responses range from 0-3. The total score ranges from 0-42, with higher scores reflecting more severe symptoms | Assessments will be conducted at baseline, 3 months post intervention | 
| Change in Physical Health Status as measured by The Revised Sign & Symptom Check-List for HIV (Holzemer, et al.; 45 items) at 2 weeks post intervention | Physical Health will be assessed using the following standardized scale: The Revised Sign & Symptom Check-List for HIV (Holzemer, et al.; 45 items). The Symptoms Checklist total scores range from 0-135, with greater scores reflecting more symptoms. | Assessments will be conducted at baseline, 2 weeks post intervention | 
| Change in Physical Health Status as measured by The Revised Sign & Symptom Check-List for HIV (Holzemer, et al.; 45 items) at 3 months post intervention | Physical Health will be assessed using the following standardized scale: The Revised Sign & Symptom Check-List for HIV (Holzemer, et al.; 45 items). The Symptoms Checklist total scores range from 0-135, with greater scores reflecting more symptoms. | Assessments will be conducted at baseline, 3 months post intervention | 
| Change in Physical Health Status as measured by The HIV-related Fatigue Scale (Belza, et al.,16 items) at 2 weeks post intervention | Physical Health will be assessed using the following standardized scale: The HIV-related Fatigue Scale (Belza, et al.,16 items) . The total score for the Fatigue Scale ranges from 0-50, with greater scores reflecting more fatigue. | Assessments will be conducted at baseline, 2 weeks post intervention | 
| Change in Physical Health Status as measured by The HIV-related Fatigue Scale (Belza, et al.,16 items) at 3 months post intervention | Physical Health will be assessed using the following standardized scale: The HIV-related Fatigue Scale (Belza, et al.,16 items) . The total score for the Fatigue Scale ranges from 0-50, with greater scores reflecting more fatigue. | Assessments will be conducted at baseline, 3 months post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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qigong, HIV