Chronic PainwHOPENCT04330365

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

A study testing Whole Health Team (WHT) Intervention Arm, Primary Care Group Education (PC-GE) Intervention Arm, Usual Primary Care (UPC) Arm in people with Chronic Pain, run by San Francisco Veterans Affairs Medical Center at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Chronic Pain
What is being tested?: Whole Health Team (WHT) Intervention Arm, Primary Care Group Education (PC-GE) Intervention Arm, Usual Primary Care (UPC) Arm
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 793 participants
Where: 6 sitesUnited States
Study dates: 15 Sep 2020to 23 Jan 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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)

Who cannot join

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.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

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

Other trials in United States

About this study

Official title: 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.

Conditions: Chronic Pain
Being tested: Whole Health Team (WHT) Intervention Arm, Primary Care Group Education (PC-GE) Intervention Arm, Usual Primary Care (UPC) Arm
Medical subject headings: Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Whole Health Team (WHT) Intervention Arm, Primary Care Group Education (PC-GE) Intervention Arm, Usual Primary Care (UPC) ArmBehavioural
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.

Study groups in NCT04330365
Study group	Role	What they receive
Whole Health Team (WHT) Intervention Arm	Active comparator	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. Receives: Behavioral: Whole Health Team (WHT) Intervention Arm, Primary Care Group Education (PC-GE) Intervention Arm, Usual Primary Care (UPC) Arm
Primary Care Group Education (PC-GE) Intervention Arm	Active comparator	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. Receives: Behavioral: Whole Health Team (WHT) Intervention Arm, Primary Care Group Education (PC-GE) Intervention Arm, Usual Primary Care (UPC) Arm
Usual Primary Care (UPC) Arm	Placebo comparator	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. Receives: Behavioral: Whole Health Team (WHT) Intervention Arm, Primary Care Group Education (PC-GE) Intervention Arm, Usual Primary Care (UPC) Arm

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 12 months

Secondary outcomes (14)

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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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).
Measured: 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).
Measured: 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.)
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Sep 202023 Jan 2025

First posted1 Apr 2020
Study start15 Sep 2020
Primary completion23 Jan 2025
Study completion23 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Chronic PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 793 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04330365
Sponsor's protocol ID: UH3AT009765
Other IDs: UH3AT009765
Acronym: wHOPE
Status last verified: May 2026
First submitted: 23 Mar 2020
Last updated: 2 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 32826776
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.
PubMed 34693748
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.
PubMed 33313734
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.
PubMed 40026674
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.
PubMed 38689119
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.
PubMed 37464147
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 Veterans Affairs' Whole Health Approach for Chronic Pain Management: The wHOPE Randomized Clinical Trial. JAMA. 2026 May 26;335(20):1774-1786. doi: 10.1001/jama.2026.5006.
PubMed 42054020

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT04330365
Acronym / sponsor ID: wHOPE / UH3AT009765
Conditions: Chronic Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 793 participants (actual)
Lead sponsor: San Francisco Veterans Affairs Medical CenterUS federal agency
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Study start: 15 Sep 2020 (actual)
Primary completion: 23 Jan 2025 (actual)
Study completion: 23 Jan 2025 (actual)
First posted: 1 Apr 2020 (actual)
Results: Posted 2 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Whole Health Team (WHT) Intervention Arm	Active comparator	Behavioral: Whole Health Team (WHT) Intervention Arm, Primary Care Group Education (PC-GE) Intervention Arm, Usual Primary Care (UPC) ArmThe 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.
Primary Care Group Education (PC-GE) Intervention Arm	Active comparator	Behavioral: Whole Health Team (WHT) Intervention Arm, Primary Care Group Education (PC-GE) Intervention Arm, Usual Primary Care (UPC) ArmPrimary 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.
Usual Primary Care (UPC) Arm	Placebo comparator	Behavioral: Whole Health Team (WHT) Intervention Arm, Primary Care Group Education (PC-GE) Intervention Arm, Usual Primary Care (UPC) ArmIn 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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)

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Whole Health Team (WHT) Intervention Arm, Primary Care Group Education (PC-GE) Intervention Arm, Usual Primary Care (UPC) ArmParticipants 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.	Behavioural	Primary Care Group Education (PC-GE) Intervention Arm, Usual Primary Care (UPC) Arm, Whole Health Team (WHT) Intervention Arm

Primary outcome

Change in Pain Interference
Time frame: 12 months
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).

14 secondary outcomes

Change in Pain Severity
Time frame: 12 months
Functioning (VR-12 Physical Component Score)
Time frame: 12 months
Quality of Life (VR-12 Mental Component Score)
Time frame: 12 months
PROMIS Sleep Disturbance
Time frame: 12 months
Engagement in a Greater Number of Non-pharmacological Pain Management Activities
Time frame: 12 months
Suicidal Ideation
Time frame: 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)
Time frame: 12 months
BPI Total Score
Time frame: 12 months
Anxiety (GAD-7)
Time frame: 12 months
Depression (PHQ-9)
Time frame: 12 months
Positive PTSD Screen (PC-PTSD-5)
Time frame: 12 months
Substance Use (TAPS-2)
Time frame: 12 months
Patient Global Impression of Change (PGIC)
Time frame: 12 months
Alcohol Use (AUDIT-C)
Time frame: 12 months

Results and safety

Results posted to the registry on 2 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Whole Health Team (WHT) Intervention	343	316
Primary Care Group Education (PC-GE) Intervention	339	307
Usual Care (UC)	82	81

Primary outcome: Change in Pain Interference

Time frame: 12 months. Least squares mean (Standard Error). Unit: scores on a scale

Measure	Whole Health Team (WHT) Intervention Arm n = 279	Primary Care Group Education (PC-GE) Intervention Arm n = 274	Usual Primary Care (UPC) Arm n = 79
Value	4.91 (0.16)	5.49 (0.18)	5.69 (0.20)

Whole Health Team (WHT) Intervention Arm vs Primary Care Group Education (PC-GE) Intervention Arm: Mean Difference (Final Values): -0.58 (95% CI -1.11 to -0.05), p = .02, Regression, Linear
Whole Health Team (WHT) Intervention Arm vs Usual Primary Care (UPC) Arm: Mean Difference (Final Values): -0.77 (95% CI -1.40 to -0.15), p = .002, Regression, Linear
Primary Care Group Education (PC-GE) Intervention Arm vs Usual Primary Care (UPC) Arm: Mean Difference (Final Values): -0.19 (95% CI -0.89 to 0.50), p = 0.46, Regression, Linear

Population analysed: Some participants dropped out of the study prior to completing the 12-month assessment. Other participants either failed to complete the 12-month assessment or elected to not answer specific questions.

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment until end of follow-up, up to 410 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Whole Health Team (WHT) Intervention Arm	78 of 343 (22.7%)	164 of 343 (47.8%)	1 of 343
Primary Care Group Education (PC-GE) Intervention Arm	57 of 339 (16.8%)	160 of 339 (47.2%)	1 of 339
Usual Primary Care (UPC) Arm	18 of 82 (22%)	38 of 82 (46.3%)	1 of 82

Limitations and caveats (from the sponsor): Generalizability of this study is limited to a veteran population that was predominantly White and male. Only a small proportion of those assessed for eligibility enrolled. There was unmeasured variability across sites that is inherent in pragmatic trial design. Clinicians and patients were not masked, and the patient-reported outcomes may have been influenced by patients' knowledge of group assignment. As a pragmatic trial, study group interventions were not balanced for time and attention.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 32826776Purcell 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.
Background: PubMed 34693748Tong 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.
Background: PubMed 33313734Seal 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.
Results publication: PubMed 40026674Seal 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.
Results publication: PubMed 38689119Moore 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.
Results publication: PubMed 37464147Denneson 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.
Derived from this study: PubMed 42054020Seal 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 Veterans Affairs' Whole Health Approach for Chronic Pain Management: The wHOPE Randomized Clinical Trial. JAMA. 2026 May 26;335(20):1774-1786. doi: 10.1001/jama.2026.5006.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Karen H Seal, MD principal investigator

San Francisco VA Health Care System

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pain Interference (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04330365, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.