Mindfulness Intervention for HIV and Chronic Pain
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Florida State University
Disqualifiers: No HIV, Severe pain, Mindfulness training
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
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.
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.
12345Is 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.
13567How 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.
348910Eligibility 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.
I am 18 years old or older.
HIV+
+2 more
Exclusion Criteria
My pain prevents me from completing tasks.
I have completed mindfulness training before.
I do not have HIV.
Trial 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)
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: ONE Mindfulness-Oriented Recovery EnhancementExperimental Treatment1 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 UsualActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Brain Science and Symptom Management CenterTallahassee, FL
Loading ...
Who Is Running the Clinical Trial?
Florida State UniversityLead Sponsor
References
The application of mindfulness for individuals living with HIV in South Africa: A hybrid effectiveness-implementation pilot study. [2020]Despite the recent growth of mindfulness research worldwide, there remains little research examining the application of mindfulness-based interventions in resource-limited, international settings. This study examined the application of Mindfulness Based Stress Reduction (MBSR) for HIV-infected individuals in South Africa, where rates of HIV are highest in the world. Mixed methods were used to examine the following over a three-month follow up: (1) feasibility, acceptability, and preliminary adaptation of MBSR for this new context; and (2) effects of MBSR on immune functioning, self-reported mindfulness (MAAS, FFMQ), depression, anxiety, and stress (DASS-21). Ten individuals initiated MBSR, and seven completed all eight sessions. Results indicated medium effect size improvements in immune functioning (CD4 count and t-cell count; d = .5) through the three-month follow up, though the small sample size limited power to detect a statistically significant effect. From baseline to post-treatment, improvements in "Observing" and "Non-reactivity" (FFMQ) approached statistical significance with large effect sizes (observing: d = 1.5; p = .08; non-reactivity: d = .7; p = .07). There were no statistically significant changes in depression, anxiety, or stress throughout the study period. Primary areas for adaptation of MBSR included emphasis on informal practice, ways to create "space" without much privacy, and ways to concretize the concepts and definitions of mindfulness. Feedback from participants can shape future adaptations to MBSR for this and similar populations. Findings provide preliminary evidence regarding the implementation of MBSR for individuals living with HIV in South Africa. A future randomized clinical trial with a larger sample size is warranted.
The Emerging Role of Mindfulness Meditation as Effective Self-Management Strategy, Part 2: Clinical Implications for Chronic Pain, Substance Misuse, and Insomnia. [2018]Mindfulness-based interventions have been increasingly utilized in the management of chronic pain since 1982. This second review of a two-part series evaluates the efficacy, mechanism, and safety of mindfulness meditation for chronic pain, substance use disorder, tobacco use disorder, and insomnia frequently co-occurring after return from deployment. Standard databases were searched until August 4, 2015. 72 relevant systematic reviews and clinical trials met the inclusion criteria. The Strength of Recommendation Taxonomy was used to assess the quality of individual studies and to rate the strength of recommendation (SOR) for each clinical condition. Mindfulness-based interventions effectively and durably reduce pain intensity, improve functional status, pain-related psychological consequences, quality of life (SOR B). They can also be utilized as an adjunctive intervention aimed at improving health-related quality of life in individuals with substance use disorders interested in self-management strategies (SOR B). Mindfulness training for smokers used adjunctively with pharmacotherapy shows efficacy in maintaining abstinence comparable to that of the current standard of care (SOR B). Future large, well-designed randomized clinical trials using active controls in service members and veterans with co-occurring pain and psychological health conditions are necessary to provide more precise clinical guidance.
A Mixed-Methods Pilot Study of Mindfulness-Based Stress Reduction for HIV-Associated Chronic Pain. [2018]Treatment guidelines for chronic pain recommend nonpharmacologic modalities as part of a comprehensive management plan. Chronic pain is common among people living with HIV/AIDS, but there is little data to guide the choice of nonpharmacologic therapies in this complex population. We performed a mixed-methods feasibility study of Mindfulness-Based Stress Reduction (MBSR) versus health education control with 32 inner city, HIV-infected participants. Outcome measures included: the Brief Pain Inventory, Perceived Stress Scale, HIV Symptoms Index, autonomic function testing, and audiotaped focus groups. Post-intervention, participants reported modest improvements in pain measures and perceived stress, but no effect of group assignment was observed. At 3-month follow-up, 79% of MBSR participants were still practicing, and pain intensity was improved, whereas in the control group pain intensity had worsened. Qualitative analysis revealed a strong sense of community in both groups, but only MBSR was perceived as useful for relaxation and pain relief.
Physical functioning and mindfulness skills training in chronic pain: a systematic review. [2023]The importance of improved physical function as a primary outcome in the treatment of chronic pain is widely accepted. There have been limited attempts to assess the effects mindfulness skills training (MST) has on objective outcomes in chronic pain care.
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]A mindfulness-based intervention that reduces comorbid pain, anxiety, and substance use during office-based opioid treatment (OBOT) could enhance retention and prevent overdose. We conducted a pilot study of the Mindful Recovery OUD Care Continuum (M-ROCC), a 24-week trauma-informed program with a motivationally-sensitive curriculum.
Perceptions about mindfulness-based interventions among individuals recovering from opioid and alcohol use disorders: Findings from focus groups. [2020]Mindfulness-based interventions (MBIs) have been used as an intervention to support recovery from alcohol use disorder (AUD) and opioid use disorder (OUD). We sought to identify attitudes and experiences toward standardized MBIs among individuals recovering from these substance abuse disorders (SUD) through a qualitative approach.
Mindfulness-Based Interventions for Adults Living with HIV/AIDS: A Systematic Review and Meta-analysis. [2023]This meta-analysis examined the effects of mindfulness-based interventions (MBIs) on stress, psychological symptoms, and biomarkers of disease among people living with HIV/AIDS (PLWHA). Comprehensive searches identified 16 studies that met the inclusion criteria (N = 1059; M age = 42 years; 20% women). Participants had been living with HIV for an average of 8 years (range =
A Randomized Pilot Trial of a Novel Behavioral Intervention for Chronic Pain Tailored to Individuals with HIV. [2023]Chronic pain is an important and understudied comorbidity in people living with HIV (PLWH). We conducted a pilot trial of Skills TO Manage Pain (STOMP), an innovative social cognitive theory-based pain self-management intervention tailored to PLWH, to assess feasibility, acceptability, and preliminary efficacy. Eligibility criteria included being HIV+, ≥ moderate pain for ≥ 3 months and a score of ≥ 4 on the three-item PEG pain severity and interference scale. Participants were randomized in a 1:1 fashion to STOMP or a usual care comparison. Among 22 participants randomized to STOMP, median session attendance was 9/12 (75%). Of 19 STOMP participants surveyed, 13 reported being "much better" overall since beginning treatment. Brief pain inventory-total scores decreased by 2 points in the intervention group and 0.9 in the control group (p = 0.11). STOMP is feasible, acceptable, and shows preliminary evidence of efficacy and promise for a full-scale trial.
Evaluation of the efficacy and mechanisms of a novel intervention for chronic pain tailored to people with HIV: The STOMP protocol. [2023]Behavioral interventions for chronic pain among people with HIV (PWH) are understudied, with great potential to improve pain and function. Chronic pain is an important comorbidity that affects between 30% and 85% of PWH and is associated with greater odds of functional impairment, increased emergency room utilization, suboptimal retention in HIV care, and failure to achieve virologic suppression. However, to date, there are few effective and scalable interventions for chronic pain in PWH.
Do mindfulness-based interventions reduce pain intensity? A critical review of the literature. [2022]Mindfulness-based interventions (MBIs) emphasizing a nonjudgmental attitude toward present moment experience are widely used for chronic pain patients. Although changing or controlling pain is not an explicit aim of MBIs, recent experimental studies suggest that mindfulness practice may lead to changes in pain tolerance and pain intensity ratings.