A Mind Body Intervention to Reduce Symptoms Among People Aging With HIV
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Detailed 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 = 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Qigong Intervention 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
Qigong is a low-impact, slow-movement, meditative form of exercise that has helped relieve mental and physical stressors.
|
| Sham Comparator: Sham Qigong 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
This intervention includes similar body movements to qigong; however, it does not have the meditative or breath work.
|
| No Intervention: Treatment-as-usual This group will receive no classes. |
Outcome Measures
Primary Outcome Measures
- Satisfaction with weekly Intervention Sessions [Assessments will be conducted once in Week 1]
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
- Satisfaction with weekly Intervention Sessions [Assessments will be conducted once in Week 2]
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
- Satisfaction with weekly Intervention Sessions [Assessments will be conducted once in Week 3]
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
- Satisfaction with weekly Intervention Sessions [Assessments will be conducted once in Week 4]
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
- Satisfaction with weekly Intervention Sessions [Assessments will be conducted once in Week 5]
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
- Satisfaction with weekly Intervention Sessions [Assessments will be conducted once in Week 6]
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
- Satisfaction with weekly Intervention Sessions [Assessments will be conducted once in Week 7]
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
- Satisfaction with weekly Intervention Sessions [Assessments will be conducted once in Week 8]
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
- Satisfaction with weekly Intervention Sessions [Assessments will be conducted once in Week 9]
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
- Satisfaction with weekly Intervention Sessions [Assessments will be conducted once in Week 10]
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
- Satisfaction with weekly Intervention Sessions [Assessments will be conducted once in Week 11]
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
- Satisfaction with weekly Intervention Sessions [Assessments will be conducted once in Week 12]
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
- Satisfaction with weekly home practice sessions [Assessments will be conducted once in Week 1]
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
- Satisfaction with weekly home practice sessions [Assessments will be conducted once in Week 2]
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
- Satisfaction with weekly home practice sessions [Assessments will be conducted once in Week 3]
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
- Satisfaction with weekly home practice sessions [Assessments will be conducted once in Week 4]
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
- Satisfaction with weekly home practice sessions [Assessments will be conducted once in Week 5]
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
- Satisfaction with weekly home practice sessions [Assessments will be conducted once in Week 6]
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
- Satisfaction with weekly home practice sessions [Assessments will be conducted once in Week 7]
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
- Satisfaction with weekly home practice sessions [Assessments will be conducted once in Week 8]
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
- Satisfaction with weekly home practice sessions [Assessments will be conducted once in Week 9]
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
- Satisfaction with weekly home practice sessions [Assessments will be conducted once in Week 10]
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
- Satisfaction with weekly home practice sessions [Assessments will be conducted once in Week 11]
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
- Satisfaction with weekly home practice sessions [Assessments will be conducted once in Week 12]
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
- Satisfaction with home practice sessions at 3 months [Assessments will be conducted at 3 months post intervention]
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
- Intervention Session Attendance (reported as percentages) [Assessments will be conducted once at Week 1]
The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance).
- Intervention Session Attendance (reported as percentages) [Assessments will be conducted once at Week 2]
The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance).
- Intervention Session Attendance (reported as percentages) [Assessments will be conducted once at Week 3]
The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance).
- Intervention Session Attendance (reported as percentages) [Assessments will be conducted once at Week 4]
The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance).
- Intervention Session Attendance (reported as percentages) [Assessments will be conducted once at Week 5]
The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance).
- Intervention Session Attendance (reported as percentages) [Assessments will be conducted once at Week 6]
The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance).
- Intervention Session Attendance (reported as percentages) [Assessments will be conducted once at Week 7]
The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance).
- Intervention Session Attendance (reported as percentages) [Assessments will be conducted once at Week 8]
The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance).
- Intervention Session Attendance (reported as percentages) [Assessments will be conducted once at Week 9]
The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance).
- Intervention Session Attendance (reported as percentages) [Assessments will be conducted once at Week 10]
The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance).
- Intervention Session Attendance (reported as percentages) [Assessments will be conducted once at Week 11]
The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance).
- Intervention Session Attendance (reported as percentages) [Assessments will be conducted once at Week 12]
The investigators will collect attendance after each weekly session (>75% of sessions attended is considered good attendance).
- Duration of weekly home practice sessions [Assessments will be conducted once at Week 1]
The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)
- Duration of weekly home practice sessions [Assessments will be conducted once at Week 2]
The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)
- Duration of weekly home practice sessions [Assessments will be conducted once at Week 3]
The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)
- Duration of weekly home practice sessions [Assessments will be conducted once at Week 4]
The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)
- Duration of weekly home practice sessions [Assessments will be conducted once at Week 5]
The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)
- Duration of weekly home practice sessions [Assessments will be conducted once at Week 6]
The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)
- Duration of weekly home practice sessions [Assessments will be conducted once at Week 7]
The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)
- Duration of weekly home practice sessions [Assessments will be conducted once at Week 8]
The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)
- Duration of weekly home practice sessions [Assessments will be conducted once at Week 9]
The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)
- Duration of weekly home practice sessions [Assessments will be conducted once at Week 10]
The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)
- Duration of weekly home practice sessions [Assessments will be conducted once at Week 11]
The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)
- Duration of weekly home practice sessions [Assessments will be conducted once at Week 12]
The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)
- Duration of home practice sessions at 3 months [Assessments will be conducted at 3 months post intervention]
The investigators will also collect information on home practice sessions: how long were each practice session (reported in minutes)
- Frequency of home practice sessions [Assessments will be conducted once in Week 1]
The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)
- Frequency of home practice sessions [Assessments will be conducted once in Week 2]
The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)
- Frequency of home practice sessions [Assessments will be conducted once in Week 3]
The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)
- Frequency of home practice sessions [Assessments will be conducted once in Week 4]
The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)
- Frequency of home practice sessions [Assessments will be conducted once in Week 5]
The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)
- Frequency of home practice sessions [Assessments will be conducted once in Week 6]
The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)
- Frequency of home practice sessions [Assessments will be conducted once in Week 7]
The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)
- Frequency of home practice sessions [Assessments will be conducted once in Week 8]
The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)
- Frequency of home practice sessions [Assessments will be conducted once in Week 9]
The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)
- Frequency of home practice sessions [Assessments will be conducted once in Week 10]
The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)
- Frequency of home practice sessions [Assessments will be conducted once in Week 11]
The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)
- Frequency of home practice sessions [Assessments will be conducted once in Week 12]
The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)
- Frequency of home practice sessions at 3 months [Assessments will be conducted at 3 months post intervention]
The investigators will also collect information on home practice sessions: how often did they practice (# of days/week)
- Will older people living with HIV still be practicing the intervention 3 months post intervention? [Assessments will be conducted at 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.
Secondary Outcome Measures
- Change in Mental Health at 2 weeks post intervention [Assessments will be conducted at baseline, 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
- Change in Mental Health at 3 months post intervention [Assessments will be conducted at baseline, 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
- 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 [Assessments will be conducted at baseline, 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.
- 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 [Assessments will be conducted at baseline, 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.
- Change in Physical Health Status as measured by The HIV-related Fatigue Scale (Belza, et al.,16 items) at 2 weeks post intervention [Assessments will be conducted at baseline, 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.
- Change in Physical Health Status as measured by The HIV-related Fatigue Scale (Belza, et al.,16 items) at 3 months post intervention [Assessments will be conducted at baseline, 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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Borinquen Medical Centers of Miami Dade | Miami | Florida | United States | 33137 |
Sponsors and Collaborators
- Florida International University
- Arizona State University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1R34AT009966-01