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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a special mindfulness training can help people with both HIV and chronic pain. One group will receive the mindfulness training, called Mindfulness-Oriented Recovery Enhancement (MORE), which involves techniques to manage pain and boost positive emotions. The other group will continue their usual treatments without the new training. Individuals with chronic pain who are HIV-positive might be a good fit, especially if they haven't tried mindfulness before. Participants must stick with their current treatments and not try any new ones during the study.

As an unphased trial, this study offers a unique opportunity to explore innovative mindfulness techniques that could enhance well-being.

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 prior data suggests that this mindfulness intervention is safe for individuals with HIV and chronic pain?

Research has shown that Mindfulness-Oriented Recovery Enhancement (MORE) is generally safe and well-tolerated. In previous studies, MORE helped people with chronic pain and issues like opioid misuse. These studies did not find any serious negative side effects from the treatment. Participants often find the mindfulness exercises calming and helpful for managing pain and negative emotions. This suggests that joining a trial involving MORE is likely safe, with little risk of harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ONE Mindfulness-Oriented Recovery Enhancement (MORE) treatment for HIV and chronic pain because it offers a fresh approach compared to traditional pain management options like medications and physical therapy. Unlike standard treatments that often focus solely on physical symptoms, ONE MORE incorporates mindfulness techniques to help participants manage pain by breaking it down into sensory, emotional, and cognitive components. This method not only addresses the physical aspect of pain but also empowers individuals to handle the emotional and mental challenges that can worsen their experience of pain. By promoting positive emotions through mindful savoring, ONE MORE aims to improve overall well-being, making it a holistic option for those dealing with chronic pain.

What evidence suggests that ONE Mindfulness-Oriented Recovery Enhancement is effective for HIV and chronic pain?

Research shows that Mindfulness-Oriented Recovery Enhancement (MORE), which participants in this trial may receive, can help reduce chronic pain and improve mental well-being. Studies have found that MORE decreases opioid misuse and the symptoms of chronic pain. In clinical trials, people using MORE reported feeling less pain and better emotional health. This therapy teaches mindfulness, focusing attention and managing thoughts to lessen pain and stress. Overall, evidence suggests that MORE can be an effective tool for those dealing with chronic pain and related issues. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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

HIV+

Fluent English speaker

Will commit to try no other new treatments during study duration

Exclusion Criteria

My pain prevents me from completing tasks.

I have completed mindfulness training before.

I do not have HIV.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9476401/

Mindfulness-Oriented Recovery Enhancement for Addictive ... Mindfulness-Oriented Recovery Enhancement (MORE) is an integrative intervention designed to ameliorate addiction, chronic pain, and psychiatric symptoms.

2. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2789279

Mindfulness-Oriented Recovery Enhancement vs ... Objective To evaluate the efficacy of Mindfulness-Oriented Recovery Enhancement (MORE) for the reduction of opioid misuse and chronic pain.

3. drericgarland.com drericgarland.com/about-m-o-r-e/

Mindfulness in Therapy | M.O.R.E. Mindfulness-Oriented Recovery Enhancement (MORE) is an evidence-based therapy, supported by more than 16 clinical trials and over $80 million in federal ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02602535

Study Details | NCT02602535 | Mindfulness-Oriented ... The central aim of this study is to test the efficacy of Mindfulness-Oriented Recovery Enhancement (MORE), an intervention designed to disrupt the risk chain.

5. sciencedirect.com sciencedirect.com/science/article/pii/S088539241400219X

Mindfulness-Oriented Recovery Enhancement Ameliorates ... Findings demonstrate preliminary efficacy of MORE as a treatment for pain-related functional impairments and suggest that effects may be more pronounced and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06481501

Mindfulness Intervention for Individuals With HIV and ... 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 ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38196335/

Mindfulness-Oriented Recovery Enhancement for Veterans ... This randomized clinical trial evaluated the efficacy of Mindfulness-Oriented Recovery Enhancement (MORE) among past and present US military personnel

8. sciencedirect.com sciencedirect.com/science/article/pii/S2451865422000795

Protocol for mindfulness-oriented recovery enhancement ... This paper describes the protocol for a randomized controlled trial (RCT) evaluating the effects of the specific mindfulness-based intervention Mindfulness- ...

9. bpspubs.onlinelibrary.wiley.com bpspubs.onlinelibrary.wiley.com/doi/abs/10.1111/bcp.16147

Mindfulness‐Oriented Recovery Enhancement: Implementing ... This review discusses the clinical outcomes, biobehavioural mechanisms and implementation considerations for a novel, evidence-based ...