Mind-Body Skills for Chronic Pain

(RAMP UG3 Trial)

Overseen By Lee Cross, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Minneapolis Veterans Affairs Medical Center

Disqualifiers: Severe psychiatric, Substance use, others

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: Unknown

Duration: 12 weeks

40 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that Mind-Body Skills for Chronic Pain is an effective treatment?

The available research shows that Mind-Body Skills for Chronic Pain, also known as the RAMP program, is effective in improving mental health and reducing negative thoughts related to pain. In one study, participants who took part in a Mindfulness-Based Chronic Pain Management course reported better mental health compared to those on a waiting list. Another study focusing on veterans found that participants felt more aware and in control of their pain, even though the intensity of the pain didn't change significantly. These findings suggest that the program can help people manage their pain better, especially in rural areas where access to alternative treatments is limited. ^{1 2 3 4 5}

What safety data exists for the Mind-Body Skills for Chronic Pain treatment?

The provided research does not directly address safety data for the Mind-Body Skills for Chronic Pain treatment or its variants like the RAMP program. However, the studies discuss the use of nonpharmacological interventions, such as telehealth services, acceptance and commitment therapy, and mind-body medicine, which are generally considered safe alternatives to opioid treatments for chronic pain. The case report on a Marine using a Mind Body Medicine program showed improvements in psychological health and quality of life, suggesting potential safety and efficacy, but specific safety data is not detailed in the abstracts. ^{5 6 7 8 9}

Is the RAMP program a promising treatment for chronic pain?

Yes, the RAMP program is a promising treatment for chronic pain. It uses mind-body skills to help people manage their pain, improve their mental health, and feel more in control of their lives. Studies show that similar mindfulness-based programs can help reduce how much pain affects daily life and improve the quality of life for veterans and others with chronic pain. ^{1 3 4 10 11}

What is the purpose of this trial?

This project addresses the significant challenge of providing evidence-based non-pharmacologic pain management to rural-dwelling Veterans in the VA healthcare system who have chronic pain. For this preparatory phase (UG3) the investigators will conduct a pilot study of 40 rural VA patients with chronic pain to assess the feasibility of delivering RAMP (experimental intervention for the UH3 trial) in terms of recruitment and engagement, intervention fidelity and adherence, data collection, and other key metrics.

Eligibility Criteria

This trial is for rural Veterans in the VA healthcare system who are experiencing chronic pain. The study aims to test a non-drug pain management program called RAMP, delivered through telehealth services.

Inclusion Criteria

Brief Pain Inventory (BPI) Pain Interference subscale score of 4 or greater

I can attend study sessions online via video calls.

Veteran participants must be rural dwelling

Exclusion Criteria

Current enrollment in a research study for pain

Current enrollment in a similar facilitated, multi-week, multi-modal CIH program

Severe, poorly controlled psychiatric or substance use disorder (based on chart review using structured checklists, conducted by trained staff who are trained and supervised by a clinical psychologist)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the RAMP intervention to assess feasibility in terms of recruitment, engagement, and adherence

12 weeks

Telehealth sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• RAMP program

Trial Overview The pilot study will assess the feasibility of delivering the RAMP program to participants. It's focused on measuring how well recruitment and engagement work, whether participants stick with the program, and how data collection processes perform.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

RAMP program is already approved in United States for the following indications:

Approved in United States as RAMP for:

• Chronic pain management

Who Is Running the Clinical Trial?

Minneapolis Veterans Affairs Medical Center

Lead Sponsor

Trials

77

Recruited

355,000+

Findings from Research

The Mindfulness-Based Chronic Pain Management course, delivered over 10 weeks, significantly improved mental health and reduced pain catastrophizing in both in-person and videoconferencing groups compared to waitlist controls, indicating its efficacy in managing chronic pain.

While both delivery methods were effective, participants receiving in-person instruction reported better physical quality of life and lower pain ratings than those attending via videoconferencing, suggesting that in-person interaction may enhance certain outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating distance education of a mindfulness-based meditation programme for chronic pain management. Gardner-Nix, J., Backman, S., Barbati, J., et al.[2019]

A 4-week Pain Coping Strategies (PCS) program significantly improved mood, functional status, and physical ability in 31 chronic pain patients, as measured by standardized scales before and 6 weeks after the program.

The study suggests that early intervention with pain management strategies can effectively promote self-management and positive coping skills in chronic pain patients, even while they are undergoing other medical treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study of a 4-week Pain Coping Strategies (PCS) programme for the chronic pain patient. Mead, K., Theadom, A., Byron, K., et al.[2011]

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 Mindfulness-Based Chronic Pain Management (MBCPM) program showed feasibility in a study with 31 veterans, leading to significant improvements in pain catastrophizing scores, indicating better coping strategies, although pain intensity itself did not significantly change.

Qualitative feedback from participants highlighted feelings of connection, increased awareness, and a sense of control, suggesting that the program may enhance overall quality of life for veterans dealing with chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Mindfulness-Based Intervention for Veterans Managing Chronic Pain. Chen, SP., Liu, HT., Appelt, JC., et al.[2023]

The VA Puget Sound Pain Telehealth pilot program successfully delivered chronic pain care to rural patients through telehealth services, providing 501 encounters over two years from 2016 to 2018.

This program included various evidence-based treatments such as pain education, cognitive-behavioral therapy, and opioid-safety education, addressing the challenge of accessing alternative pain management options in underserved areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bringing chronic-pain care to rural veterans: A telehealth pilot program description. Glynn, LH., Chen, JA., Dawson, TC., et al.[2022]

The Veterans Health Administration is developing an online program called Veteran ACT for Chronic Pain (VACT-CP) to help veterans manage chronic pain through acceptance and commitment therapy (ACT), which has a strong evidence base for improving pain outcomes.

A pilot feasibility randomized controlled trial (RCT) is currently underway with 40 participants to assess the usability of the VACT-CP system, aiming to provide insights into treatment satisfaction and pain-related functioning by late 2023.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Online Acceptance and Mindfulness Intervention for Chronic Pain in Veterans: Development and Protocol for a Pilot Feasibility Randomized Controlled Trial. Reilly, ED., Kathawalla, UK., Robins, HE., et al.[2023]

A Marine with chronic pain participated in a 6-week Mind Body Medicine program, which led to significant improvements in his perceived disability, psychological health, sleep quality, and overall quality of life.

The case suggests that self-care practices like meditation can be effective in managing chronic pain, highlighting the need for further research into these complementary therapies within military healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mind body medicine in the care of a U.S. Marine with chronic pain: a case report. Millegan, J., Morrison, T., Bhakta, J., et al.[2017]

A 6-month self-management program for chronic pain, tailored for low-income, primarily Hispanic patients, showed significant improvements in pain severity and interference, with both individual and group delivery methods being effective.

Out of 111 participants, both intervention arms demonstrated clinically significant changes in multiple outcomes, indicating the program's potential efficacy in managing chronic pain in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Trial of a Low-Literacy Chronic Pain Self-Management Program: Analysis of Secondary Pain and Psychological Outcome Measures. Turner, BJ., Liang, Y., Rodriguez, N., et al.[2021]

A study involving 26 veterans from the ESCAPE trial revealed that both responders and non-responders to a multicomponent intervention for chronic pain developed a better understanding of their pain, which helped them manage it more effectively.

Veterans reported that recognizing the physical and psychosocial factors related to their pain was crucial, suggesting that traditional measures of pain relief may not fully capture the benefits of such interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"There's more to this pain than just pain": how patients' understanding of pain evolved during a randomized controlled trial for chronic pain. Matthias, MS., Miech, EJ., Myers, LJ., et al.[2022]

A randomized controlled trial in a rural, low-literacy population showed that cognitive behavioral therapy (CBT) was more effective than an active education condition in managing chronic pain, with participants in the CBT group reporting greater depth and breadth of change.

Qualitative analysis of interviews from 28 CBT and 24 education participants revealed key treatment elements and processes of change from the patients' perspectives, highlighting the importance of patient-centered approaches in adapting treatments for underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A qualitative analysis of a randomized controlled trial comparing a cognitive-behavioral treatment with education. Day, MA., Thorn, BE., Kapoor, S.[2023]

This randomized trial will involve 300 individuals with chronic pain, focusing on the effectiveness of cognitive therapy, mindfulness meditation, and activation skills over eight telehealth sessions, aiming to understand how early changes in cognitive and activity levels predict improvements in pain interference.

The study will utilize advanced methods like ecological momentary assessment and structural equation modeling to analyze the mechanisms of treatment effects, which could lead to better strategies for maintaining pain relief and reducing relapse risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial to examine the mechanisms of cognitive, behavioral and mindfulness-based psychosocial treatments for chronic pain: Study protocol. Day, MA., Ehde, DM., Burns, J., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Evaluating distance education of a mindfulness-based meditation programme for chronic pain management. [2019]

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

Pilot study of a 4-week Pain Coping Strategies (PCS) programme for the chronic pain patient. [2011]

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

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

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

Feasibility of Mindfulness-Based Intervention for Veterans Managing Chronic Pain. [2023]

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

Bringing chronic-pain care to rural veterans: A telehealth pilot program description. [2022]

6. Canada pubmed.ncbi.nlm.nih.gov

An Online Acceptance and Mindfulness Intervention for Chronic Pain in Veterans: Development and Protocol for a Pilot Feasibility Randomized Controlled Trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Mind body medicine in the care of a U.S. Marine with chronic pain: a case report. [2017]

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

Randomized Trial of a Low-Literacy Chronic Pain Self-Management Program: Analysis of Secondary Pain and Psychological Outcome Measures. [2021]

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

"There's more to this pain than just pain": how patients' understanding of pain evolved during a randomized controlled trial for chronic pain. [2022]

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

A qualitative analysis of a randomized controlled trial comparing a cognitive-behavioral treatment with education. [2023]

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

A randomized trial to examine the mechanisms of cognitive, behavioral and mindfulness-based psychosocial treatments for chronic pain: Study protocol. [2021]