Recruiting

Whole Health Coaching

Sponsor:

VA Office of Research and Development

Code:

NCT07149870

Conditions

Chronic Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pain Management Team + Whole Health Coach (PMT-WHC)

Pain Management Team-Usual Care (PMT-UC)

Study Details

Brief summary:

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 currently working with a pain management team (PMT) at the VA.

Conditions

Chronic Pain

Study ID

NCT07149870

Start date

Nov 20, 2025

Status verified date

Aug, 2026

Completion date

Oct 1, 2029

Anticipated

Primary completion date

Oct 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. High-impact chronic pain (defined using the Graded Chronic Pain Scale - Revised).
2. Active prescription for long-term opioid therapy (LTOT; including full agonist and buprenorphine) (>90 days continuous prescription).
3. Exhibit evidence of at least ONE opioid safety concern (\*indicators of opioid safety concerns described below).

  • Opioid safety concerns for inclusion purposes include:

1. moderate-to-high dose opioid prescription (morphine equivalent daily dose >60mg)
2. comorbid conditions that increase the risk of full-agonist opioids including chronic pulmonary disease (e.g., emphysema, chronic bronchitis, asthma, or other breathing problems), sleep apnea, chronic kidney disease, chronic hepatitis or cirrhosis
3. active high-risk co-prescriptions, including long-term benzodiazepine prescription, gabapentin or pregabalin, nonbenzodiazepine hypnotic agents or sedative hypnotics, or skeletal muscle relaxants
4. a positive TAPS or AUDIT-C score
5. reported score of >8 as measured by the Prescribed Opioids Difficulties Scale (PODS).

Exclusion Criteria:

1. Moderate to severe cognitive impairment as measured by the Blessed Orientation Memory Concentration (BOMC) screening tool.
2. Inability to read or understand English.
3. Severely impaired hearing or speech that would preclude participation in telephone interviews or appointments with the Whole Health Coach.
4. Terminal illness/disease with a prognosis of <12 months.
5. Planned move/relocation outside of the treatment areas of the participating enrolling study sites.
6. Participants actively working with a Whole Health Coach or who have worked with a Whole Health Coach in the 6-months prior to enrollment.
7. Major surgical procedure planned during the study treatment or follow-up period.
8. a recent suicide attempt, defined as documented and/or reported suicide attempt within 90 days of the screening date.

Study Design

Enrollment

432 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: PMT-WHC

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

active comparator: PMT-UC

The PMT-UC group will receive PMT Usual Care

Interventions

Pain Management Team + Whole Health Coach (PMT-WHC)

Whole Health Coaching (WHC) begins by completing a Personalized Health Inventory (PHI), where progress is evaluated within 8 dimensions of health and wellness. The PHI culminates in defining personal values and overall goals for health and wellness (i.e., "What do you want your health for?"). This is used to create goals for a Personal Health Plan. The Plan emphasizes self-management strategies to manage pain. After the Plan is developed, ongoing support is provided from the Coach through 8-12 coaching sessions over approximately 5 months.

Pain Management Team-Usual Care (PMT-UC)

Pain Management Team-Usual Care (PMT-UC) involves working with VA PMTs that includes working with PMTs comply with legislation requiring each medical center to have PMTs with expertise in pain, addiction, behavioral approaches, and rehabilitation approaches. PMTs will conduct multidisciplinary intakes (at least two provider types) with biopsychosocial assessments for all new patients. Follow-up care will be determined by the PMTs based on what is clinically indicated (with recommended minimum medication management follow ups at 1- 3- and 6-months for patients making medication changes).

Primary outcome measure

  • Composite of Pain Interference and Opioid Safety [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

Birmingham VA Medical Center, Birmingham, AL

Recruiting

Birmingham, Alabama, United States, 35233-1927

Contacts

Rocky Mountain Regional VA Medical Center, Aurora, CO

Recruiting

Aurora, Colorado, United States, 80045-7211

Contacts

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

Recruiting

West Haven, Connecticut, United States, 06516-2770

Contacts

Principal Investigator:

Sara Edmond, PhD

Boise VA Medical Center, Boise, ID

Recruiting

Boise, Idaho, United States, 83702

Contacts

More Information

Sponsor

VA Office of Research and Development

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Keywords

  • Opioid Use
  • Opioid Safety
  • Pain
  • Chronic Pain
  • Long-term Opioid Therapy
  • Pain Management
  • Opioid
  • Whole Health
  • Coaching
  • Whole Health Coaching
  • Pain, Chronic
  • Buprenorphine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-08-17.