Mindfulness Intervention for HIV and Chronic Pain

Overseen By Adam Hanley, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Florida State University

Disqualifiers: No HIV, Severe pain, Mindfulness training

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 2 hours

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must not start any new treatments during the study.

What data supports the effectiveness of the treatment Mindfulness-Oriented Recovery Enhancement (MORE) for HIV and chronic pain?

Research shows that mindfulness-based treatments can help reduce pain intensity and improve quality of life for people with chronic pain. A study on Mindfulness-Based Stress Reduction (MBSR) found that participants with HIV reported improved pain and stress levels after practicing mindfulness, suggesting that similar mindfulness approaches like MORE could be beneficial. ^{1 2 3 4 5}

Is the mindfulness intervention safe for humans?

The available research on mindfulness-based interventions, including Mindfulness-Based Stress Reduction (MBSR), suggests they are generally safe for humans, with no significant adverse effects reported in studies involving individuals with HIV and chronic pain. ^{1 3 5 6 7}

How is the Mindfulness-Oriented Recovery Enhancement treatment different from other treatments for HIV and chronic pain?

Mindfulness-Oriented Recovery Enhancement (MORE) is unique because it combines mindfulness training with cognitive-behavioral techniques to help people with HIV manage chronic pain by focusing on present-moment awareness and emotional regulation, which is different from traditional pain treatments that often rely on medication. ^{3 4 8 9 10}

What is the purpose of this trial?

This project is a single-site, two-arm, randomized controlled pilot study examining the impact of a 2-hour version of Mindfulness-Oriented Recovery Enhancement (ONE MORE) training for individuals with HIV and chronic pain.

Eligibility Criteria

This trial is for individuals living with HIV who also experience chronic pain. Specific eligibility details are not provided, but typically participants would need to meet certain health criteria and be able to commit to the study's requirements.

Inclusion Criteria

I have been diagnosed with chronic pain.

HIV+

Fluent English speaker

Exclusion Criteria

My pain prevents me from completing tasks.

I have completed mindfulness training before.

I do not have HIV.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 2-hour version of Mindfulness-Oriented Recovery Enhancement (ONE MORE) training, divided into four 30-minute segments focusing on mindfulness, pain management, reappraisal, and savoring.

2 hours

1 visit (in-person)

Follow-up

Participants are monitored for changes in pain, mindfulness, and other psychological measures over a 4-week period post-treatment.

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• ONE Mindfulness-Oriented Recovery Enhancement

Trial Overview The trial is testing a program called ONE Mindfulness-Oriented Recovery Enhancement (ONE MORE). It involves a 2-hour training session designed to help manage HIV-related chronic pain through mindfulness techniques.

Participant Groups

Group I: ONE Mindfulness-Oriented Recovery Enhancement Experimental Treatment 1 Intervention

One MORE is a 2-hour adaptation of the manualized MORE program and will be divided into four, 30-minute segments. In the first segment, participants will be introduced to mindfulness and guided though a body scan practice, which directs participants to systematically shift attention from one part of the body to the next. Mindful pain management will be the focus of the second segment and participants will be guided through a mindfulness of pain practice in which they will learn to deconstruct pain into sensory, emotional, cognitive, and behavioral components. The third segment will focus on managing the negative thoughts and emotion that can amplify pain with mindful reappraisal, and the fourth segment will focus on increasing the positive emotions that can attenuate pain with mindful savoring.

Group II: Treatment As Usual Active Control 1 Intervention

In the Treatment as Usual (TAU) condition, participants will complete all study assessments (pre-treatment, post-treatment, 2-week, 4-week) without receiving any ONE MORE training. During their study involvement, TAU participants will be encouraged to continue any previously initiated treatment but discouraged from beginning any new form of treatment. Those in the TAU condition will not be sent any training materials.

ONE Mindfulness-Oriented Recovery Enhancement is already approved in United States for the following indications:

Approved in United States as Mindfulness-Oriented Recovery Enhancement for:

• Chronic pain
• Opioid misuse
• Addiction
• Emotional distress

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

Findings from Research

Mindfulness Based Stress Reduction (MBSR) showed medium effect size improvements in immune functioning (CD4 and T-cell counts) among HIV-infected individuals in South Africa, suggesting potential health benefits, although the small sample size limited statistical significance.

Participants reported improvements in mindfulness skills, particularly in 'Observing' and 'Non-reactivity', with large effect sizes, indicating that MBSR can be adapted for this context, but further research with a larger sample is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The application of mindfulness for individuals living with HIV in South Africa: A hybrid effectiveness-implementation pilot study. McIntyre, TL., Elkonin, D., de Kooker, M., et al.[2020]

Mindfulness-based interventions have been shown to effectively reduce chronic pain intensity and improve overall quality of life, based on a review of 72 systematic reviews and clinical trials.

These interventions can also support individuals with substance use disorders and help maintain smoking abstinence when used alongside standard treatments, indicating their versatility in managing co-occurring health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Emerging Role of Mindfulness Meditation as Effective Self-Management Strategy, Part 2: Clinical Implications for Chronic Pain, Substance Misuse, and Insomnia. Khusid, MA., Vythilingam, M.[2018]

In a study involving 32 HIV-infected participants, Mindfulness-Based Stress Reduction (MBSR) showed modest improvements in pain and stress levels, with 79% of participants continuing the practice three months later.

While both MBSR and health education groups reported a sense of community, only MBSR was viewed as effective for relaxation and pain relief, suggesting its potential as a beneficial nonpharmacologic therapy for chronic pain in people living with HIV/AIDS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mixed-Methods Pilot Study of Mindfulness-Based Stress Reduction for HIV-Associated Chronic Pain. George, MC., Wongmek, A., Kaku, M., et al.[2018]

A systematic review of 15 randomized controlled trials involving 1,199 patients found inconclusive evidence for mindfulness skills training (MST) improving self-reported physical function in chronic pain, highlighting variability in how physical function was measured.

Strong evidence indicated that MST did not lead to improvements in physical function when assessed through performance-based measures, suggesting a need for standardized assessment methods in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical functioning and mindfulness skills training in chronic pain: a systematic review. Jackson, W., Zale, EL., Berman, SJ., et al.[2023]

The Mindful Recovery OUD Care Continuum (M-ROCC) program, a 24-week mindfulness-based intervention, significantly reduced comorbid pain and anxiety in patients undergoing buprenorphine treatment, as evidenced by improved scores on various psychological scales and decreased substance use.

Participants showed a notable decrease in positive urine toxicology results for cocaine and benzodiazepines, indicating that M-ROCC may help enhance retention in treatment and prevent substance misuse during opioid therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a trauma-informed mindful recovery program on comorbid pain, anxiety, and substance use during primary care buprenorphine treatment: A proof-of-concept study. Schuman-Olivier, Z., Fatkin, T., Creedon, TB., et al.[2023]

Participants recovering from alcohol and opioid use disorders found mindfulness-based interventions (MBIs) beneficial for their recovery, particularly valuing the non-pharmacological nature of these therapies.

Key factors influencing participation in MBIs included perceived provider empathy and social connectedness, with participants suggesting that incentives like gift cards could enhance engagement and retention in recovery programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions about mindfulness-based interventions among individuals recovering from opioid and alcohol use disorders: Findings from focus groups. Jones, KO., Lopes, S., Chen, L., et al.[2020]

Mindfulness-based interventions (MBIs) significantly reduced depressive symptoms in people living with HIV/AIDS, with a moderate effect size (d+ = 0.37) based on a meta-analysis of 16 studies involving 1059 participants.

Participants in MBIs also experienced improvements in overall psychological symptoms and quality of life over time, although no significant changes were found in immunological outcomes like CD4 counts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Interventions for Adults Living with HIV/AIDS: A Systematic Review and Meta-analysis. Scott-Sheldon, LAJ., Balletto, BL., Donahue, ML., et al.[2023]

The STOMP intervention, designed for people living with HIV and chronic pain, demonstrated good feasibility and acceptability, with 75% attendance in sessions among participants.

Preliminary results indicated a decrease in pain scores for those in the STOMP group, suggesting potential efficacy, although the difference compared to usual care was not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Pilot Trial of a Novel Behavioral Intervention for Chronic Pain Tailored to Individuals with HIV. Merlin, JS., Westfall, AO., Long, D., et al.[2023]

The STOMP intervention, a 12-week pain self-management program tailored for people with HIV (PWH) suffering from chronic pain, aims to improve pain management and overall function, addressing a significant gap in effective treatments for this population.

This randomized control trial will involve 280 participants and compare the STOMP intervention against enhanced usual care, with the potential to provide valuable evidence on improving chronic pain treatment in PWH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the efficacy and mechanisms of a novel intervention for chronic pain tailored to people with HIV: The STOMP protocol. Jones, KF., Bair, MJ., Orris, SM., et al.[2023]

Mindfulness-based interventions (MBIs) significantly reduce pain intensity in chronic pain patients, with 10 out of 16 studies showing decreased pain ratings, especially in clinical pain samples.

Most controlled trials indicated that MBIs led to greater reductions in pain intensity compared to control groups, and these benefits were generally maintained in follow-up assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do mindfulness-based interventions reduce pain intensity? A critical review of the literature. Reiner, K., Tibi, L., Lipsitz, JD.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

The application of mindfulness for individuals living with HIV in South Africa: A hybrid effectiveness-implementation pilot study. [2020]

2. England pubmed.ncbi.nlm.nih.gov

The Emerging Role of Mindfulness Meditation as Effective Self-Management Strategy, Part 2: Clinical Implications for Chronic Pain, Substance Misuse, and Insomnia. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

A Mixed-Methods Pilot Study of Mindfulness-Based Stress Reduction for HIV-Associated Chronic Pain. [2018]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Physical functioning and mindfulness skills training in chronic pain: a systematic review. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Effects of a trauma-informed mindful recovery program on comorbid pain, anxiety, and substance use during primary care buprenorphine treatment: A proof-of-concept study. [2023]

6. Scotland pubmed.ncbi.nlm.nih.gov

Perceptions about mindfulness-based interventions among individuals recovering from opioid and alcohol use disorders: Findings from focus groups. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Interventions for Adults Living with HIV/AIDS: A Systematic Review and Meta-analysis. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

A Randomized Pilot Trial of a Novel Behavioral Intervention for Chronic Pain Tailored to Individuals with HIV. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the efficacy and mechanisms of a novel intervention for chronic pain tailored to people with HIV: The STOMP protocol. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Do mindfulness-based interventions reduce pain intensity? A critical review of the literature. [2022]