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.
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.
12345What 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.
14678Is 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.
29101112Eligibility 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.
+1 more
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.
+2 more
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Health CoachingExperimental Treatment1 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 PsychotherapyPlacebo Group1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJEast Orange, NJ
Loading ...
Who Is Running the Clinical Trial?
VA Office of Research and DevelopmentLead Sponsor
References
Current trends in health coaching for chronic conditions: A systematic review and meta-analysis of randomized controlled trials. [2023]Chronic conditions are placing a serious burden on individuals as well as the health care system. Health coaching (HC) has emerged as a promising approach that can support effective lifestyle interventions for chronic conditions. However, until now there is no particularly comprehensive systematic review of HC impact on a chronic condition from the angle of patient improvement and detail coaching characteristics reported.
Randomized controlled trial protocol of health coaching for veterans with complex chronic pain. [2023]Pain predominant multisymptom illness (pain-CMI) refers to symptom-based conditions where pain is a primary symptom. There is initial evidence that health coaching may be efficacious in treating pain-CMI because it can be tailored to the veteran's goals and emphasizes long-term behavior change, which may indirectly impact the maintaining factors of pain-CMI (e.g., catastrophizing, poor pain control, and limited activity). This paper describes the study protocol and rationale of a randomized controlled trial that will compare the efficacy of remote-delivered health coaching in reducing disability and pain impairment for veterans with pain-CMI to remote-delivered supportive psychotherapy.
The Role of Health Coaching in Pain and Palliative Care Pharmacy Practice. [2023]Whole-person care is essential in the management of patients with chronic pain and serious illness. Pain, suffering, and comfort do not fall under typical chronic disease management and cannot be boxed nicely into algorithms of evidence-focused, biomarker-based goal achievement like hypertension or diabetes. Current therapies, including surgical, interventional, and analgesic modalities may be only marginally effective, and have brought with them questionable practices, high cost, and an opioid epidemic. Patient-focused goals are gaining favor, and exploration of methods to enhance this approach include health coaching. In the setting of pain management, this would include pain coaching. This commentary will highlight the role of health coaching in the setting of chronic disease and pain management, and the pharmacists' qualifications and potential contributions to health and pain coaching.
Integration of Health Coaches in a Whole Health Team Model of Chronic Pain Care: a Qualitative Study. [2023]Health coaching has shown promise in helping patients manage their chronic disease and in improving health outcomes, yet the implementation of health coaching in healthcare systems is understudied. Further, evidence suggests that interdisciplinary care teams may be more effective in treating chronic pain than usual care. As such, we sought to examine the benefits and drawbacks to embedding health coaches within interdisciplinary pain care teams ("Whole Health Teams").
The impact of health and wellness coaching on patient-important outcomes in chronic illness care: A systematic review and meta-analysis. [2023]Health and Wellness Coaching (HWC) may be beneficial in chronic condition care. We sought to appraise its effectiveness on quality of life (QoL), self-efficacy (SE), depression, and anxiety.
Dosing of Health and Wellness Coaching for Obesity and Type 2 Diabetes: Research Synthesis to Derive Recommendations. [2023]Health and wellness coaching (HWC) is an effective intervention for lifestyle disease such as obesity and type 2 diabetes. The evolving HWC profession needs recommendations to guide clinical practice, particularly the appropriate dose of coaching. The purpose of this paper was to systematically review and synthesize HWC literature to derive HWC programming recommendations. Of 102 papers retrieved, 88 were retained with data extracted determining HWC session number, frequency, duration, program length, and total coaching load. Differential analysis yielded no statistical difference in programming variables for randomized control trials and other designs, nor for studies with significant findings v. those not finding statistical significance, allowing these data to be pooled. The HWC intervention for obesity was slightly more intense (15 sessions over 7-8 mo) than the diabetes programming (12 sessions over 9-10 mo). On average, HWC programming applied in the peer-reviewed literature was 12-15 sessions of 35-40 min duration over 7-9 months. These recommendations for HWC programming variables are put forth as initial practice guidelines and should be examined with comparative effectiveness study for optimization. HWC best practice guidelines for other patient groups (e.g., heart disease, cancer, and chronic pain) should also be studied once an adequate literature data base is available.
Health coaching: a new and exciting technique to enhance patient self-management and improve outcomes. [2019]Health coaching is quickly emerging as a new approach of partnering with patients to enhance self-management strategies for the purpose of preventing exacerbations of chronic illness and supporting lifestyle change. Medicare is now pilot testing this approach for patients with congestive heart failure and diabetes. With acute care hospitalization an outcome of great interest to us all, health coaching is an exciting technique worthy of consideration by home health providers.
Health Coaching for Low Back Pain and Hip and Knee Osteoarthritis: A Systematic Review with Meta-Analysis. [2023]Health coaching aims to empower people to reach their goals and is increasingly used in health care settings. Whether health coaching improves pain and disability for people with hip or knee osteoarthritis (OA) or low back pain (LBP) is unknown.
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]Pain is common for hematopoietic stem cell transplant (HSCT) patients and may be experienced pre-transplant, acutely post-transplant, and for months or years following transplant. HSCT patients with persistent pain may be at risk for poor quality of life following transplant; however, the impact of pre-transplant pain on quality of life post-transplant is not well understood. Self-efficacy for chronic disease management is associated with quality of life among cancer patients and may impact quality of life for HSCT patients. The primary aim was to examine the effect of pre-transplant pain and self-efficacy on quality of life domains in the year following transplant.
Experiences with an educational program for patients with chronic widespread pain: a qualitative interview study. [2022]Chronic widespread pain (CWP) is a common problem in primary health care, with a prevalence of 10-15%. An educational program called Pain School has been developed for use in primary health care, comprising four educational group sessions and 10 weeks of physical activity. The purpose of this study was to explore patients' experiences with participating in an educational program that aims to increase their understanding of pain, self-efficacy, tools in daily life, and physical activity.
Chronic pain 1-5 years after heart transplantation-A nationwide cross-sectional cohort study. [2021]To provide a multidimensional assessment of self-reported chronic pain 1-5 years after heart transplantation and its relationship with self-reported well-being, fatigue, recovery, self-efficacy and socio-economic factors and to explore differences between heart recipients and a cohort of lung recipients.
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]People struggling with chronic pain may benefit from different types of non-pharmacological interventions such as self-management courses. Self-management courses aim to increase participants' skills and knowledge in managing chronic conditions. Community health-care services in Norway have increasingly established Healthy Life Centres (HLCs) to offer easily accessible interventions to people in need of support to better handle a life with chronic illness. The aim of this trial is to investigate the expectations, effect and experience of an easily accessible, group-based self-management course delivered at a HLC for people with chronic pain.