Pragmatic Trial of WHT vs. PC-GE to Promote Non-Pharmacological Strategies to Treat Chronic Pain in Veterans (wHOPE)

Implementation of a Pragmatic Trial of Whole Health Team vs. Primary Care Group Education to Promote Non-Pharmacological Strategies to Improve Pain, Functioning, and Quality of Life in Veterans

The overarching goal of this Pain Management Collaboratory Demonstration project is to test a new Whole Health paradigm for chronic pain care, emphasizing non-pharmacological pain self-management that is hypothesized to reduce pain symptoms and improve overall functioning and quality of life in Veterans. In UH3 Aim 1, the investigators will conduct a 12-month pragmatic effectiveness trial at 6 VA sites across the country to test whether veterans with moderate to severe chronic pain randomized to receive the Whole Health Team (WHT) intervention are more likely than those receiving Primary Care Group Education (PC-GE) to: Hypothesis 1: Experience improved pain interference (primary outcome), pain intensity, functioning and quality of life (secondary outcomes); Hypothesis 2: Decrease use of higher-risk pain medications, including opioids, or high-risk combinations; Hypothesis 3: Engage in a greater number of non-pharmacological pain management activities; and Hypothesis 4: Experience improved mental health-related symptoms, including sleep problems and suicidality. In addition, both the WHT and PC-GE arms will be compared to a third group of veterans randomized to Usual Primary Care (UPC, Control) on the same primary and secondary outcomes above. After the baseline assessment, masked telephone assessments will be administered to participants at 3, 6, 9, and 12 months. UH3 Aim 2 is to conduct a process evaluation of the two active interventions (WHT and PC-GE) and a budget impact analysis that includes costs to implement and execute the two active interventions as well as the control condition (UPC) to inform the development of an implementation toolkit for scaling and dissemination. Eligible participants are veterans reporting moderate to severe chronic pain present every day or nearly every day for ≥ 6 months. The total sample size for the population is based on our main study aim/hypothesis and is N=764. This breaks down to n=343 in the WHT intervention, n=339 in the PC-GE intervention, and N=82 in the Usual Primary Care arm (Control). Results of this UG3/UH3 Pain Management Collaboratory Demonstration project will contribute to the overall mission of the NIH/VA/DoD initiative to build national-level infrastructure that supports non-pharmacologic pain management in veterans and military service personnel.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Whole Health Team (WHT) Intervention Arm, Primary Care Group Education (PC-GE) Intervention Arm, Usual Primary Care (UPC) Arm

• Study Type: Interventional
• Enrollment (Actual): 793
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94121
      • SFVAHCS
  • Connecticut
    • West Haven, Connecticut, United States, 06516
      • VA Connecticut
  • Florida
    • Tampa, Florida, United States, 33612
      • James A. Haley Veterans Hospital
  • Massachusetts
    • Bedford, Massachusetts, United States, 01730
      • Bedford VAMC
  • Missouri
    • St Louis, Missouri, United States, 63125
      • VA St. Louis Health Care System
  • Oregon
    • Portland, Oregon, United States, 97239
      • VAPHCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Participants must meet the following inclusion criteria to be enrolled in the study:

• Assigned to a VA PCP;
• Report pain present every day or nearly every day for ≥ 6 months using a phone eligibility screener; and
• PEG score of ≥ 5 (including at baseline assessment)

Exclusion Criteria:

Candidates with any of the exclusion criteria at baseline will be excluded from study participation:

• Moderate or severe cognitive impairment as determined by a failed 6-item, validated cognitive screener on initial phone screening (See Appendix A: Telephone Eligibility Screen/Script);
• Active suicidality as determined by medical record review, standardized assessment (PHQ-9) and/or is unable to attend study visits because of an unstable or severe psychiatric or medical condition or is receiving palliative or hospice care; or
• Any other factors that would interfere with study participation including inability to communicate by telephone, VTEL or VVC; being a non-English speaker; plans to relocate within 12 months and concurrent participation in another pain-related study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Whole Health Team (WHT) Intervention Arm; The WHT intervention arm includes four core elements: 1) An interdisciplinary WHT collaborating with primary care; 2) Personalized Health Planning with prioritization of multi-modal non-pharmacological and CIH pain management approaches; 3) Whole Health Coaching sessions to assist patients in developing and implementing a Personalized Health Plan for chronic pain care; and 4) the web/mobile Whole Health Resource Directory provided to patient participants (in addition to their providers) to support non-pharmacologic/CIH chronic pain care.	Behavioral: Whole Health Team (WHT) Intervention Arm, Primary Care Group Education (PC-GE) Intervention Arm, Usual Primary Care (UPC) Arm; Participants will be randomly assigned at the individual level to either WHT, PC-GE or Usual Primary Care, stratified by site, sex, and use of prescribed opioids for chronic pain. The follow-up period for the three arms will be 12 months. The primary outcome is change in pain interference. Secondary outcomes include change in pain intensity, functioning, quality of life, changes in use of pain medications, including opioids (if applicable) and changes in nonpharmacological pain self-management activities. After the baseline assessment, masked telephone assessments will be administered to participants at 3, 6, 9, and 12 months.
Placebo Comparator: Usual Primary Care (UPC) Arm; In VA, patient-aligned care teams (PACTs) or primary care is step 1 of VA's Stepped Care Model in the treatment of chronic pain. PCPs are expected to possess the requisite skill set for management of common chronic pain-causing conditions, which includes biopsychosocial assessment, multi-modal treatment, and coordination of specialty pain care after shared-decision making that incorporates patient preferences and values. Participants randomized to this arm will continue to have their PCP and PACT serve in this role.	Behavioral: Whole Health Team (WHT) Intervention Arm, Primary Care Group Education (PC-GE) Intervention Arm, Usual Primary Care (UPC) Arm; Participants will be randomly assigned at the individual level to either WHT, PC-GE or Usual Primary Care, stratified by site, sex, and use of prescribed opioids for chronic pain. The follow-up period for the three arms will be 12 months. The primary outcome is change in pain interference. Secondary outcomes include change in pain intensity, functioning, quality of life, changes in use of pain medications, including opioids (if applicable) and changes in nonpharmacological pain self-management activities. After the baseline assessment, masked telephone assessments will be administered to participants at 3, 6, 9, and 12 months.
Active Comparator: Primary Care Group Education (PC-GE) Intervention Arm; Primary Care Group Education (PC-GE) is the comparator arm, which is an abbreviated form of Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) adapted for group use in primary care.	Behavioral: Whole Health Team (WHT) Intervention Arm, Primary Care Group Education (PC-GE) Intervention Arm, Usual Primary Care (UPC) Arm; Participants will be randomly assigned at the individual level to either WHT, PC-GE or Usual Primary Care, stratified by site, sex, and use of prescribed opioids for chronic pain. The follow-up period for the three arms will be 12 months. The primary outcome is change in pain interference. Secondary outcomes include change in pain intensity, functioning, quality of life, changes in use of pain medications, including opioids (if applicable) and changes in nonpharmacological pain self-management activities. After the baseline assessment, masked telephone assessments will be administered to participants at 3, 6, 9, and 12 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Interference	The total Brief Pain Inventory (BPI) interference sub-scale score is our primary outcome measure. Pain interference was calculated as the mean of the 7 pain-interference items (scale ranged 0-10; higher scores indicate greater pain interference).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Severity	Change in pain severity was measured using the pain severity subscale from the Brief Pain Inventory (BPI). Pain severity was calculated as the mean of the 4 pain-severity items (scores ranged 0-10; higher scores indicate greater pain severity).	12 months
Functioning (VR-12 Physical Component Score)	The investigators will assess functioning and quality of life using the THE VETERANS RAND 12-ITEM HEALTH SURVEY (VR-12). VR-12 scores were calculated using an algorithm provided by developers (available upon request). Functioning was determined using the physical component score. Subscales were developed to have a mean of 50 with a standard deviation of 10 in the reference population. Higher scores indicate better physical or mental functioning. Reported scores are adjusted means with corresponding standard errors, estimated using the LSMEANS statement in SAS 9.4 PROC GLIMMIX.	12 months
Quality of Life (VR-12 Mental Component Score)	The investigators will assess functioning and quality of life using the THE VETERANS RAND 12-ITEM HEALTH SURVEY (VR-12). VR-12 scores were calculated using an algorithm provided by developers (available upon request). Quality of life was determined using the mental component score. Subscales were developed to have a mean of 50 with a standard deviation of 10 in the reference population. Higher scores indicate better physical or mental functioning. Reported scores are adjusted means with corresponding standard errors, estimated using the LSMEANS statement in SAS 9.4 PROC GLIMMIX.	12 months
PROMIS Sleep Disturbance	The investigators will assess sleep and fatigue symptoms using the PROMIS - Sleep Disturbance. Sleep disturbance was scored as the sum of individual items, with items 2,3,7, and 8 reversed prior to summation (range 8-40; higher scores indicate greater sleep disturbance). The investigators will be screening for suicidality using the final question of the PHQ-9.	12 months
Engagement in a Greater Number of Non-pharmacological Pain Management Activities	Past-year use of complementary therapies and self-management practices was measured using the Nonpharmacological and Self-Care Approaches from PMC (NSCAP). Categories of nonpharmacological activities included: 1. Acupuncture; 2. Manipulation; 3. Massage; 4. Yoga; 5. Tai Chi/Qigong; 6. Exercise; 7. Relaxation techniques; 8. Meditation/mindfulness; 9. Psychotherapy/counseling; or 10. Other. Each category was counted only once.	12 months
Suicidal Ideation	Suicidal ideation was a single item analyzed as binary (yes/no) taken from the final question of the 9-item Patient Health Questionnaire (PHQ-9) which asked if participants have been bothered during the last 2 weeks by "Thoughts that you would be better off dead or of hurting yourself in some way." Values are reported from the 12-month assessment. The table indicates how many participants endorsed those thoughts "Several days", "More than half the days," and "Nearly every day" compared with "Not at all".	12 months
Decreased Use of Higher-risk Pain Medications, Including Opioids or High-risk Combinations of Pain Medications (i.e., Co-prescription of Opioids and Benzodiazepines)	The investigators will utilize the VA administrative data/databases to obtain information on prescription medications, including generic name, dispensing information, dose, and instructions. Decreased opioid dose (Morphine Equivalent Daily Dose, MEDD) from baseline (binary: yes/no).	12 months
BPI Total Score	The total BPI score was calculated as the mean of all 11 items (range 0-10; higher scores indicate greater overall pain).	12 months
Anxiety (GAD-7)	Anxiety was measured using the Generalized Anxiety Disorder 7-item measure (GAD-7). This was scored as the sum of 7 items (range 0-21; higher scores indicate greater anxiety.)	12 months
Depression (PHQ-9)	The Patient Health Questionnaire 9-item scale (PHQ-9) was used to measure depression. This was scored as the sum of 9 items (range 0-27; higher scores indicate greater depression).	12 months
Positive PTSD Screen (PC-PTSD-5)	Positive PTSD (binary outcome) was determined using the Primary Care Post-traumatic Stress Disorder 5-item (PC-PTSD-5) measure. An endorsement (yes/no) of ≥ 3 items for women and ≥4 items for men indicated probable PTSD. The table indicates how many participants screened positive for PTSD.	12 months
Substance Use (TAPS-2)	Substance use was measured using the Tobacco, Alcohol, and Substance Use (TAPS-2) tool. This outcome was binary (problem use was defined as 10+ cigarettes/day or any use within 30 minutes of waking). The table indicates how many participants were classified as having problematic substance use.	12 months
Patient Global Impression of Change (PGIC)	The Patient Global Impression of Change (PGIC) scale was used to measure patients' impressions of study impact. The PGIC is a one-item measure that asks, "How would you describe your overall status now compared to when you started in our study?" Response options include: (3) Very Much Improved, (2) Much Improved, (1) Minimally Improved, (0) No Change, (-1) Minimally Worse, (-2) Much Worse, or (-3) Very Much Worse. Scores range from -3 to 3, with 0 indicating no improvement, and higher scores indicating more improvement in impression of change.	12 months
Alcohol Use (AUDIT-C)	Alcohol problem use was measured using the Alcohol Use Disorders Identification Test Consumption (AUDIT-C). This scale contains 3 items which are added to yield scores with a range of 0-12, with higher scores indicating greater risk of high-risk alcohol use. Positive scores are defined using Version 3 cut-points of ≥ 3 for women and ≥ 4 for men. Scores for participants of all genders are reported in the table.	12 months

Collaborators and Investigators

• Sponsor: San Francisco Veterans Affairs Medical Center
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Karen H Seal, MD, San Francisco VA Health Care System

Publications and helpful links

General Publications

• Purcell N, Becker WC, Zamora KA, McGrath SL, Hagedorn HJ, Fabian ER, McCamish N, Seal KH. Tailored to Fit: How an Implementation Framework Can Support Pragmatic Pain Care Trial Adaptation for Diverse Veterans Affairs Clinical Settings. Med Care. 2020 Sep;58 Suppl 2 9S(Suppl 2 9 Suppl):S80-S87. doi: 10.1097/MLR.0000000000001376.
• Tong G, Seal KH, Becker WC, Li F, Dziura JD, Peduzzi PN, Esserman DA. Impact of complex, partially nested clustering in a three-arm individually randomized group treatment trial: A case study with the wHOPE trial. Clin Trials. 2022 Feb;19(1):3-13. doi: 10.1177/17407745211051288. Epub 2021 Oct 24.
• Seal KH, Becker WC, Murphy JL, Purcell N, Denneson LM, Morasco BJ, Martin AM, Reddy K, Iseghem TV, Krebs EE, Painter JM, Hagedorn H, Pyne JM, Hixon J, Maguen S, Neylan TC, Borsari B, DeRonne B, Gibson C, Matthias MS, Frank JW, Krishnaswamy A, Li Y, Bertenthal D, Chan A, Nunez A, McCamish N. Whole Health Options and Pain Education (wHOPE): A Pragmatic Trial Comparing Whole Health Team vs Primary Care Group Education to Promote Nonpharmacological Strategies to Improve Pain, Functioning, and Quality of Life in Veterans-Rationale, Methods, and Implementation. Pain Med. 2020 Dec 12;21(Suppl 2):S91-S99. doi: 10.1093/pm/pnaa366.
• Seal KH, Feinberg T, Moore L, Woodruff NA, Purcell N, Bertenthal D, McCamish N, Becker WR. Natural Product Use for Chronic Pain: A New Survey of Patterns of Use, Beliefs, Concerns, and Disclosure to Providers. Glob Adv Integr Med Health. 2025 Feb 27;14:27536130251320101. doi: 10.1177/27536130251320101. eCollection 2025 Jan-Dec.
• Moore LC, Woodruff NA, Seal KH, Feinberg T, Purcell N. Natural Product Use Among Veterans with Chronic Pain: A Qualitative Study of Attitudes and Communication with Healthcare Providers. J Gen Intern Med. 2024 Sep;39(12):2206-2214. doi: 10.1007/s11606-024-08746-2. Epub 2024 Apr 30.
• Denneson LM, Purcell N, McGrath SL, Abadjian LR, Becker WC, Seal KH. Integration of Health Coaches in a Whole Health Team Model of Chronic Pain Care: a Qualitative Study. J Gen Intern Med. 2023 Dec;38(16):3574-3580. doi: 10.1007/s11606-023-08317-x. Epub 2023 Jul 18.
• Seal KH, Morasco BJ, Martin AM, Reddy KP, Van Iseghem TM, Bolton RE, Bokhour BG, Murphy J, Denneson LM, Esserman D, Buta E, Purcell N, Bertenthal D, Painter JT, Abadjian LR, Moore LC, Chan AC, McCamish N, Maguen S, Neylan TC, Gibson CJ, Becker WC; wHOPE Study Group. The Veteran Affairs' Whole Health Approach for Chronic Pain Management: The wHOPE Randomized Clinical Trial. JAMA. 2026 Apr 29:e265006. doi: 10.1001/jama.2026.5006. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Actual): January 23, 2025
• Study Completion (Actual): January 23, 2025

Study Registration Dates

• First Submitted: March 23, 2020
• First Submitted That Met QC Criteria: March 30, 2020
• First Posted (Actual): April 1, 2020

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain
• Other Study ID Numbers: UH3AT009765 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No