Whole Health Coaching for Chronic Pain

(TEAMWORK Trial)

Not yet recruiting at 4 trial locations

Overseen By Deanna J Ternes, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must be taking: Opioids

Must not be taking: Buprenorphine

Disqualifiers: Cognitive impairment, Terminal illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 5 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Whole Health Coaching (WHC) can enhance pain management for veterans with chronic pain. Participants will receive either their usual pain management care or the usual care plus eight sessions of WHC. Suitable participants should have long-term pain that significantly affects their life, have been on prescribed opioid medications for over 90 days, and have concerns related to opioid safety, such as other health conditions or medication interactions. As an unphased trial, this study provides a unique opportunity to explore innovative pain management strategies.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants must have an active prescription for long-term opioid therapy and may have high-risk co-prescriptions, so it seems likely you can continue your current medications.

What prior data suggests that Whole Health Coaching is safe for chronic pain management?

Research shows that Whole Health Coaching (WHC) often leads to positive results for people with chronic pain. Studies have found that WHC can reduce pain and increase physical activity, indicating its safety and tolerance.

No reports of serious side effects from WHC exist. Instead, it helps people manage pain better when combined with regular pain care.

Overall, evidence suggests that WHC is a safe option for improving pain management. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Whole Health Coaching for chronic pain because it offers a holistic approach that goes beyond traditional methods like medication and physical therapy. This treatment emphasizes personalized coaching sessions that empower individuals to manage their pain through lifestyle changes and self-care techniques. Unlike conventional treatments that primarily focus on alleviating symptoms, Whole Health Coaching aims to address the root causes of pain by promoting overall well-being. This approach could potentially enhance the quality of life for those with chronic pain by fostering long-term, sustainable health improvements.

What evidence suggests that Whole Health Coaching is effective for chronic pain?

Research shows that Whole Health Coaching (WHC) can help manage chronic pain. In this trial, participants in the PMT-WHC group will receive PMT Usual Care plus 8 sessions of WHC. Studies have found that adding WHC to a treatment plan can lower pain levels and increase physical activity. In one study, patients who received WHC reported a better quality of life within three months. Another study found that WHC helped reduce the need for opioids, which are strong painkillers. These findings suggest that WHC could benefit people dealing with chronic pain. ^{1 2 3 5 6}

Who Is on the Research Team?

Sara Edmond, PhD

Principal Investigator

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Karen H Seal, MD MPH

Principal Investigator

San Francisco VA Medical Center, San Francisco, CA

Are You a Good Fit for This Trial?

This trial is for adults with chronic pain at the VA who are at risk of substance misuse, have high-impact chronic pain, or show opioid safety concerns like high-dose prescriptions. Excluded are those with severe cognitive impairment, non-English speakers, severe hearing/speech issues, terminal illness, planned relocation, recent buprenorphine use or Whole Health Coaching.

Inclusion Criteria

- Risk of substance use and/or potential opioid misuse as evidenced by unexpected urine toxicology findings in past 6-months or any documented active substance use disorder (other than tobacco or caffeine) as evidenced by at least 2 encounters within the previous 12-months with a substance use disorder diagnosis

- A positive TAPS score

- A positive AUDIT-C score

Exclusion Criteria

Moderate to severe cognitive impairment as measured by the Blessed Orientation Memory Concentration (BOMC) screening tool

Inability to read or understand English

Severely impaired hearing or speech that would preclude participation in telephone interviews or appointments with the Whole Health Coach

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Evaluation

Participants undergo a baseline evaluation with at least two PMT clinicians

1 week

1 visit (in-person)

Treatment

Participants receive usual care from the PMT, with the PMT-WHC group also receiving 8 sessions of Whole Health Coaching

5 months

8 visits (biweekly for 3 months, monthly for 2 months)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up appointments based on clinical judgment

6 months

At least 3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Whole Health Coaching

Trial Overview The TEAMWORK Trial is testing if adding Whole Health Coaching to a Pain Management Team's care improves outcomes for veterans with chronic pain. Participants will either receive usual care from their Pain Management Team or the same care plus support from a Whole Health Coach.

How Is the Trial Designed?

Group I: PMT-WHC Experimental Treatment 2 Interventions

The PMT-WHC group will receive PMT Usual Care plus 8 sessions of Whole Health Coaching (WHC)

Group II: PMT-UC Active Control 1 Intervention

The PMT-UC group will receive PMT Usual Care

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37464147/

Integration of Health Coaches in a Whole Health Team Model ... Embedding health coaches within interdisciplinary pain care teams may improve care processes and accelerate patient progress.

2. va.gov va.gov/WHOLEHEALTH/docs/Health-Wellness-Coaching-Outcomes-Final-Long-Version-4-9.pdf

Health and Wellness Coaching Outcomes HWC interventions for chronic pain showed benefits such as reduced pain, improved physical activity, and enhanced ... How VA Whole Health Coaching Can Impact ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07149870

Pain Management Teams Using Whole Health to Optimize ... The focus of this study is to determine whether adding Whole Health Coaching (WHC) improves pain care among adults with chronic pain and who are ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0738399123003555

The impact of health and wellness coaching on patient ... Thirty included studies demonstrated that HWC improved QoL within 3 months (SMD 0.62 95 % CI 0.22–1.02, p = 0.002), SE within 1.5 months (SMD 0.38, 95 % CI 0.03 ...

5. bmchealthservres.biomedcentral.com bmchealthservres.biomedcentral.com/articles/10.1186/s12913-022-08388-2

Effectiveness of a whole health model of care emphasizing ... VHA's Whole Health national pilot program was associated with greater reductions in prescribed opioid doses compared to secular trends associated with ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S183695532400002X

Health coaching improves physical activity, disability and ... Research. Health coaching improves physical activity, disability and pain in adults with chronic non-cancer pain: a systematic review.