An interventional study of Tai Chi and Health Coaching in HIV Infections and Chronic Pain, sponsored by Temple University. Completed at 1 site in United States. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-03-18.
Sponsored by Temple University · Not applicable, Interventional, and Treatment
Chronic pain is highly comorbid among the 1.2 million persons living with HIV, with recent prevalence estimates ranging from 55-67%. Needed are evidenced-based non-pharmacological interventions to improve chronic pain management and reduce the demand for opioids in the United States. The proposed research will address this need by examining the feasibility and acceptability of Tai Chi as a mind-body intervention for chronic pain management in an HIV population.
Persons living with HIV (PLWH) are at increased risk for chronic pain conditions, with prevalence rates estimated to be between 55-67%. While acute pain is a life-sustaining biological response to tissue damage or injury, chronic pain is a separate condition that often causes significant physical and psychological suffering. Causes of chronic pain among PLWH include disease progression, the impact of the virus on immune and nervous system function, and medication side-effects. PLWH, like many other chronic pain patients, may be prescribed opioid medications, which have not been found to be effective in managing non-cancer related chronic pain. Additionally, the significant risk of dependence and overdose far outweigh the potential benefit of opioid medications for chronic pain. Governing bodies in medicine have called for non-pharmacological interventions to be considered front-line treatment recommendations for chronic pain management. Mind-body interventions, such as mindfulness, yoga, and Tai Chi, have been shown to be effective at reducing pain symptoms and improving psychological outcomes for individuals with chronic pain. Unfortunately, few studies have examined the use of mind-body interventions for chronic pain management for PWLH, with even fewer using formative research to modify interventions to meet the unique needs of this vulnerable population. The research plan proposed in this application will address these gaps in the literature. This study will examine the feasibility and acceptability of a mind-body intervention, Qigong/Tai Chi Easy, for chronic pain management among PLWH. The researchers will recruit 40 individuals from the Comprehensive HIV Program at Temple Health. Following informed consent, participants will be randomized to mind-body arm or health education control arm. Participants in both arms will complete baseline assessment followed by a 10-week intervention. The mind-body intervention group will meet weekly for 60-minute sessions and be provided with a video for at-home practice. The health education group will also meet weekly for 60 minutes and be assigned weekly homework related to the topics discussed in session. At the conclusion of the 10 weeks, participants will complete at post-intervention assessment. A 3-month follow up assessment will also be completed. In addition to feasibility (i.e., recruitment rates, retention) and acceptability (i.e., satisfaction ratings), the researchers will assess pain symptoms (general and specific), perceived stress, depression, quality of life, and HIV medication adherence. The researchers anticipate that the study will demonstrate feasibility and acceptability as evidenced by adequate enrollment, retention, and satisfaction. Findings from the proposed study will be used to inform a future research grant with power to detect efficacy of the mind-body intervention for chronic pain management.
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This study's enrollment of 36 is below the median of 83 across 3,250 interventional studies indexed under HIV Infections.
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Exclusion Criteria:
This is the active intervention arm. Qigong/Tai Chi Easy is a manualized intervention with formal training for instructors through the Institute of Integral Qigong and Tai Chi (IIQTC). The protocol can be modified based on participant needs and physical abilities. Qigong/Tai Chi Easy uses a series of repeated and simple-to-learn movements (rather than long forms with complicated choreography).
Behavioral: Tai Chi
This is the time and attention active comparator control group arm: The Health Education group will be adapted from a previously developed time and attention control condition used in HIV research. Additional health education material will be based on information learned in the qualitative interviews conducted prior to the start of this study. Examples of session material include the following: sleep hygiene, healthy diet, sun safety, and healthy homes.
Behavioral: Health Coaching
Qigong/Tai Chi Easy is a manualized intervention with formal training for instructors through the Institute of Integral Qigong and Tai Chi (IIQTC). The protocol can be modified based on participant needs and physical abilities. Qigong/Tai Chi Easy uses a series of repeated and simple-to-learn movements (rather than long forms with complicated choreography).
The Health Education group will be adapted from a previously developed time and attention control condition used in HIV research. Additional health education material will be based on information learned in the qualitative interviews conducted prior to the start of this study. Examples of session material include the following: sleep hygiene, healthy diet, sun safety, and healthy homes.
Pain Intensity - Brief Pain Inventory
Participants will be asked to rate their pain, ranging from 0, no pain, to 10, most extreme pain, on average in the past week. Higher scores indicate worse pain.
Time frame: Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)
Pain Interference - Brief Pain Inventory
A self-report of impairment in mobility, impairment in activities of daily living, mood, and pain-related anxiety/fear. The pain interference subscale score is the average of 7 items, with responses that range from 0-10. Higher scores indicate worse pain interference.
Time frame: Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)
Feasibility to Execute Study Protocol
Ability to recruit and retain participants through intervention and follow-up assessments
Time frame: Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)
Participant Satisfaction Questionnaire (PSQ) - Acceptability
Participant self-reported satisfaction with intervention components. Response to question: "How would you rate your overall satisfaction with this program?"
Time frame: Post-Intervention (Weeks 10-12)
Perceived Stress Scale (PSS)
The Perceived Stress Scale is a measure of self-reported stress in the past month. There are 13 items and responses range from 0 (never) to 4 (very often). A total score is calculated and can range from 0 to 52, with higher scores indicated a greater degree of perceived stress.
Time frame: Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)
Patient Health Questionnaire (PHQ-8)
The PHQ-9 is a commonly used measure of depression with strong psychometric properties for clinical populations. The scale consists of 8 items, with responses ranging from 0 (not at all) to 3 (nearly every day). Total scores are calculated and possible scores range from 0 to 24, with higher scores indicated more depressive symptoms.
Time frame: Baseline (Week 0), Post-Intervention (Weeks 10-12), 3-month Follow Up (Weeks 22-24)
| Milestone | Gentle Movement | Health Coaching |
|---|---|---|
| Started | 18 | 18 |
| Completed | 18 | 18 |
| Not completed | 0 | 0 |
Participants will be asked to rate their pain, ranging from 0, no pain, to 10, most extreme pain, on average in the past week. Higher scores indicate worse pain.
| units on a scale | Gentle Movement | Health Coaching |
|---|---|---|
| Baseline (Week 0) | 7.3 ± 1.8 | 6.6 ± 1.9 |
| Post-Intervention (Weeks 10-12) | 6.1 ± 2.2 | 6.1 ± 2.2 |
| 3-month Follow Up (Weeks 22-24) | 5.6 ± 2.9 | 7.4 ± 2.1 |
A self-report of impairment in mobility, impairment in activities of daily living, mood, and pain-related anxiety/fear. The pain interference subscale score is the average of 7 items, with responses that range from 0-10. Higher scores indicate worse pain interference.
| score on a scale | Gentle Movement | Health Coaching |
|---|---|---|
| Baseline (Week 0) | 5.9 ± 1.5 | 5.8 ± 2.3 |
| Post-Intervention (Weeks 10-12) | 4.7 ± 3.3 | 5.8 ± 2.0 |
| 3-month Follow Up (Weeks 22-24) | 5.4 ± 3.3 | 6.5 ± 2.7 |
Ability to recruit and retain participants through intervention and follow-up assessments
| Participants | Gentle Movement | Health Coaching |
|---|---|---|
| Post-Intervention (Weeks 10-12) — Retained at Follow Up | 16 | 16 |
| Post-Intervention (Weeks 10-12) — Missing Data | 2 | 2 |
| 3-month Follow Up (Weeks 22-24) — Retained at Follow Up | 16 | 16 |
| 3-month Follow Up (Weeks 22-24) — Missing Data | 2 | 2 |
Participant self-reported satisfaction with intervention components. Response to question: "How would you rate your overall satisfaction with this program?"
| Participants | Gentle Movement | Health Coaching |
|---|---|---|
| Very Satisfied | 11 | 10 |
| Mostly Satisfied | 3 | 4 |
| Indifferent | 2 | 2 |
| No Response | 2 | 2 |
The Perceived Stress Scale is a measure of self-reported stress in the past month. There are 13 items and responses range from 0 (never) to 4 (very often). A total score is calculated and can range from 0 to 52, with higher scores indicated a greater degree of perceived stress.
| score on a scale | Gentle Movement | Health Coaching |
|---|---|---|
| Baseline (Week 0) | 25.7 ± 4.5 | 28.1 ± 5.2 |
| Post-Intervention (Weeks 10-12) | 26.0 ± 5.0 | 26.6 ± 4.8 |
| 3-month Follow Up (Weeks 22-24) | 26.9 ± 3.7 | 26.3 ± 4.2 |
The PHQ-9 is a commonly used measure of depression with strong psychometric properties for clinical populations. The scale consists of 8 items, with responses ranging from 0 (not at all) to 3 (nearly every day). Total scores are calculated and possible scores range from 0 to 24, with higher scores indicated more depressive symptoms.
| score on a scale | Gentle Movement | Health Coaching |
|---|---|---|
| Baseline (Week 0) | 10.8 ± 7.0 | 12.4 ± 5.2 |
| Post-Intervention (Weeks 10-12) | 9.4 ± 7.8 | 10.3 ± 7.1 |
| 3-month Follow Up (Weeks 22-24) | 9.1 ± 7.1 | 9.4 ± 6.0 |
Collected over 24 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Gentle Movement | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Health Coaching | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Age, Continuous(years) | Gentle Movement | Health Coaching | Total |
|---|---|---|---|
| Mean | 60 ± 7.3 | 61 ± 7.0 | 61 ± 7 |
| Sex: Female, Male(Participants) | Gentle Movement | Health Coaching | Total |
|---|---|---|---|
| Female | 12 | 12 | 24 |
| Male | 6 | 6 | 12 |
| Race (NIH/OMB)(Participants) | Gentle Movement | Health Coaching | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 15 | 11 | 26 |
| White | 2 | 5 | 7 |
| More than one race | 1 | 2 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Gentle Movement | Health Coaching | Total |
|---|---|---|---|
| United States | 18 | 18 | 36 |
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