Health Coaching for Chronic Pain Syndrome

Overseen By Lisa M McAndrew, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Compensation: Varies

Number of Visits: 14

Duration: 12 weeks

260 Participants Needed

Trial Summary

What is the purpose of this trial?

The National Academy of Medicine (NAM) labels chronic pain as one of the most extensive health care issues facing our society with "severe impacts on all aspects of the lives of its sufferers."1 Pain predominant chronic multisymptom illness (Pain-CMI, e.g., fibromyalgia) is a particularly debilitating and presumptive service connected condition for Veterans who deployed to the Gulf region. Health coaching is an appealing potential approach to improve the disability of Pain-CMI because it is personalized to the Veteran's unique goals and beliefs about Pain-CMI and it will be widely available as the VA is rolling out health coaching. The goal of this proposal is to understand if health coaching is also efficacious for a complex pain condition, Pain-CMI.

Do I have to stop taking my current medications for the trial?

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

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the idea that Health Coaching for Chronic Pain Syndrome is an effective treatment?

The available research shows that health coaching can be effective for managing chronic pain. One study highlights that health coaching can be tailored to individual goals and focuses on long-term behavior change, which can help reduce pain and disability. Another study suggests that health coaching, when integrated into a team approach, may be more effective than usual care for chronic pain. Additionally, health coaching is seen as a promising alternative to traditional therapies, which often have limited effectiveness and high costs. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Health Coaching for Chronic Pain Syndrome?

Research suggests that health coaching can help manage chronic conditions by supporting lifestyle changes and improving health outcomes. It may also be effective in reducing disability and pain impairment, especially when tailored to individual goals and combined with interdisciplinary care. ^{1 2 3 4 5}

What safety data exists for health coaching in treating chronic pain?

The provided research does not directly address safety data for health coaching in treating chronic pain. However, health coaching is generally considered a supportive intervention aimed at enhancing patient self-management and improving outcomes for chronic conditions. The studies focus on the effectiveness and implementation of health coaching rather than specific safety concerns. Further research specifically addressing safety data would be needed to provide a comprehensive answer. ^{1 2 6 7 8}

Is health coaching safe for humans?

The research does not specifically address safety concerns, but health coaching is generally considered a safe approach as it involves supporting patients in managing their health and lifestyle changes. ^{1 2 6 7 8}

Is Health Coaching a promising treatment for Chronic Pain Syndrome?

Yes, Health Coaching is promising for Chronic Pain Syndrome because it can be personalized to fit individual goals and focuses on long-term behavior changes. This approach can help reduce pain and improve quality of life by addressing factors like poor pain control and limited activity. ^{3 9 10 11 12}

How is the Health Coaching treatment different from other treatments for chronic pain syndrome?

Health Coaching for chronic pain syndrome is unique because it focuses on personalized, long-term behavior change tailored to individual goals, which can help address factors like negative thinking and limited activity that contribute to chronic pain. Unlike standard treatments that may focus on medication or immediate symptom relief, this approach emphasizes self-management and empowerment to improve overall quality of life. ^{3 9 10 11 12}

Research Team

Lisa Marie McAndrew, PhD

Principal Investigator

East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ

Eligibility Criteria

This trial is for Veterans with chronic pain syndrome, specifically Pain-CMI as defined by the Kansas City (Steele) criteria. Participants must experience significant activity limitations and widespread pain. Those with psychotic disorders, severe cognitive impairments, life-threatening conditions, current pregnancy or plans to become pregnant soon are excluded.

Inclusion Criteria

I rate my activity limitations as 3 or more on a scale of 0 to 10.

You have Chronic Multisymptom Illness that meets the definition of CMI according to the Kansas City (Steele) criteria.

I experience widespread pain rated at least 4 out of 10.

Exclusion Criteria

You have expressed or shown intention to harm yourself.

I have severe difficulty with thinking or memory.

You have a mental illness called psychotic disorder or you are pregnant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 12-session remote health coaching intervention or supportive psychotherapy over 12 weeks

12 weeks

12 sessions (remote)

Mid-treatment Assessment

Participants complete an assessment to evaluate progress and adjust treatment if necessary

6 weeks

1 assessment (remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

1 follow-up assessment (remote)

Treatment Details

Interventions

• Health Coaching
• Supportive Psychotherapy

Trial Overview The study is testing whether health coaching can help improve the lives of veterans suffering from chronic multisymptom illness related to pain. It's a personalized approach that aligns with the veteran's own goals and beliefs about their condition.

Participant Groups

Group I: Health Coaching Experimental Treatment 1 Intervention

The 12-session remote health coaching intervention assists Veterans in developing and maintaining health behaviors that meet their life goals. Veterans begin by discussing their symptoms, the impact of their symptoms, and their beliefs about Pain-CMI. Next, the Veteran identifies discrepancies between where they are and where they want to be for 5 lifestyle factors. The first half of treatment focuses on providing education about the 5 lifestyle factors. Veterans are introduced to behavior change/health coaching principles. The major focus is on behavior change and development of long-term healthy habits. During the last session, Veterans develop a long-term plan to maintain behavioral changes after the 12-week program and identify the skills that they can utilize moving forward.

Group II: Supportive Psychotherapy Placebo Group 1 Intervention

Our control will be supportive psychotherapy which will focus on discussing weekly stressors in a supportive, non-directive way. Session content is patient-driven, and sessions focus on emphasizing the patients' strengths, following patients' emotional affect, and building a therapeutic alliance. Participants will be asked to generate the topic they would like to discuss for the session and will complete a worksheet between sessions noting emotional events throughout their week ("A time when I felt stressed was ." ) in order to help identify experiences for discussion in session. The control consists of 12 weekly sessions delivered via telephone or video and will be delivered by bachelor's, or master's level providers.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

Embedding health coaches within interdisciplinary pain care teams, known as Whole Health Teams, can enhance patient progress and improve care processes, as reported by 22 stakeholders involved in a multisite clinical trial across five Veterans Health Administration sites.

While the team model fosters valuable collaboration and efficiency, successful implementation requires strong communication, role clarity, and commitment among team members to overcome logistical challenges, particularly in patient goal setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integration of Health Coaches in a Whole Health Team Model of Chronic Pain Care: a Qualitative Study. Denneson, LM., Purcell, N., McGrath, SL., et al.[2023]

This systematic review aims to evaluate the effectiveness of health coaching (HC) interventions for adults with chronic conditions, synthesizing studies published in the last four years to assess patient improvement and coaching characteristics.

If health coaching is found to be effective, it could lead to broader public health applications and integration into current management strategies for chronic diseases, potentially improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current trends in health coaching for chronic conditions: A systematic review and meta-analysis of randomized controlled trials. Yang, J., Bauer, BA., Lindeen, SA., et al.[2023]

This study will evaluate the effectiveness of remote-delivered health coaching in reducing disability and pain impairment in veterans with pain predominant multisymptom illness (pain-CMI) compared to supportive psychotherapy, with assessments at multiple time points over 24 weeks.

The trial aims to explore additional benefits of health coaching, such as reducing physical symptoms and catastrophizing, while promoting better pain control and activity levels, potentially offering a tailored approach to managing pain-CMI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial protocol of health coaching for veterans with complex chronic pain. Crosky, S., McFarlin, M., Sullivan, N., et al.[2023]

Whole-person care is crucial for managing chronic pain and serious illnesses, as traditional disease management approaches often overlook the complexities of pain and comfort.

Health coaching, particularly pain coaching, is emerging as a valuable method to support patient-focused goals in pain management, with pharmacists playing a key role in this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Health Coaching in Pain and Palliative Care Pharmacy Practice. Kral, LA.[2023]

Health and Wellness Coaching (HWC) significantly improves quality of life (QoL) within 3 months and self-efficacy (SE) within 1.5 months in individuals with chronic conditions, based on a meta-analysis of 30 studies.

HWC also shows a positive impact on reducing depression over 3, 6, and 12 months, although the evidence quality is low due to risks of bias and variability in study results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of health and wellness coaching on patient-important outcomes in chronic illness care: A systematic review and meta-analysis. Boehmer, KR., Álvarez-Villalobos, NA., Barakat, S., et al.[2023]

Health and wellness coaching (HWC) is effective for managing lifestyle diseases like obesity and type 2 diabetes, with recommended programming involving 12-15 sessions lasting 35-40 minutes each over a period of 7-9 months.

For obesity, a slightly more intense approach is suggested, with 15 sessions over 7-8 months, compared to 12 sessions over 9-10 months for diabetes, indicating tailored coaching intensity may be beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosing of Health and Wellness Coaching for Obesity and Type 2 Diabetes: Research Synthesis to Derive Recommendations. Sforzo, GA., Kaye, MP., Faber, A., et al.[2023]

Health coaching is being tested by Medicare as a method to help patients with chronic illnesses like congestive heart failure and diabetes improve their self-management and lifestyle changes.

This approach aims to prevent hospitalizations, making it a promising strategy for home health providers to support patients in managing their conditions effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health coaching: a new and exciting technique to enhance patient self-management and improve outcomes. Huffman, M.[2019]

Health coaching significantly reduces pain and disability in individuals with chronic low back pain (LBP), with notable mid-term pain reduction and improvements in both short-term and mid-term disability.

For knee osteoarthritis (OA), health coaching also leads to significant long-term improvements in functional disability, although there is no evidence available for its effectiveness in hip OA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Coaching for Low Back Pain and Hip and Knee Osteoarthritis: A Systematic Review with Meta-Analysis. Prior, JL., Vesentini, G., Michell De Gregorio, JA., et al.[2023]

In a study of 166 hematopoietic stem cell transplant (HSCT) patients, pre-transplant pain was linked to lower physical well-being in the year following the transplant, indicating that managing pain before the procedure is crucial for better outcomes.

Self-efficacy in managing chronic disease was found to significantly influence quality of life across all domains post-transplant, suggesting that enhancing patients' confidence in self-management could improve their overall well-being after HSCT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of pre-transplant pain and chronic disease self-efficacy on quality of life domains in the year following hematopoietic stem cell transplantation. O'Sullivan, ML., Shelby, RA., Dorfman, CS., et al.[2022]

The Pain School educational program, which includes four group sessions and 10 weeks of physical activity, effectively helps women with chronic widespread pain (CWP) develop skills and perspectives to better manage their pain, as reported by participants in a qualitative study of 12 women aged 25-72.

Participants experienced increased understanding of their bodies and minds, valued social interaction, and learned new strategies for coping with pain, indicating that the program provides practical tools for improving self-efficacy in managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences with an educational program for patients with chronic widespread pain: a qualitative interview study. Goksör, C., Mannerkorpi, K., Bergenheim, A.[2022]

Chronic pain is prevalent among heart transplant recipients, with those experiencing low psychological well-being and high fatigue reporting significantly more pain, highlighting the need for comprehensive pain management.

The study, involving 79 heart recipients over 1-5 years post-transplant, found that female recipients were particularly affected by pain, suggesting that gender differences should be considered in post-transplant care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic pain 1-5 years after heart transplantation-A nationwide cross-sectional cohort study. Dalvindt, M., Kisch, A., Nozohoor, S., et al.[2021]

This trial investigates the effectiveness of a 6-week group-based self-management course for chronic pain, aiming to improve patient activation and self-efficacy among participants, with a target enrollment of 120 individuals.

The study will also explore participants' experiences and motivations through qualitative interviews, providing insights into how such easily accessible interventions can help individuals manage chronic pain in a community health setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expectations, effect and experiences of an easily accessible self-management intervention for people with chronic pain: study protocol for a randomised controlled trial with embedded qualitative study. Nøst, TH., Steinsbekk, A., Bratås, O., et al.[2023]

References

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

Integration of Health Coaches in a Whole Health Team Model of Chronic Pain Care: a Qualitative Study. [2023]

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

Current trends in health coaching for chronic conditions: A systematic review and meta-analysis of randomized controlled trials. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Randomized controlled trial protocol of health coaching for veterans with complex chronic pain. [2023]

4. England pubmed.ncbi.nlm.nih.gov

The Role of Health Coaching in Pain and Palliative Care Pharmacy Practice. [2023]

5. Ireland pubmed.ncbi.nlm.nih.gov

The impact of health and wellness coaching on patient-important outcomes in chronic illness care: A systematic review and meta-analysis. [2023]

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

Dosing of Health and Wellness Coaching for Obesity and Type 2 Diabetes: Research Synthesis to Derive Recommendations. [2023]

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

Health coaching: a new and exciting technique to enhance patient self-management and improve outcomes. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Health Coaching for Low Back Pain and Hip and Knee Osteoarthritis: A Systematic Review with Meta-Analysis. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

The effect of pre-transplant pain and chronic disease self-efficacy on quality of life domains in the year following hematopoietic stem cell transplantation. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Experiences with an educational program for patients with chronic widespread pain: a qualitative interview study. [2022]

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

Chronic pain 1-5 years after heart transplantation-A nationwide cross-sectional cohort study. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Expectations, effect and experiences of an easily accessible self-management intervention for people with chronic pain: study protocol for a randomised controlled trial with embedded qualitative study. [2023]