An interventional study of Whole Health Team (WHT) Intervention Arm, Primary Care Group Education (PC-GE) Intervention Arm, Usual Primary Care (UPC) Arm in Chronic Pain, sponsored by San Francisco Veterans Affairs Medical Center. Completed at 6 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by San Francisco Veterans Affairs Medical Center · Not applicable, Interventional, and Treatment
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.
Participants must meet the following inclusion criteria to be enrolled in the study:
Exclusion Criteria:
Candidates with any of the exclusion criteria at baseline will be excluded from study participation:
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
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
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.
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).
Time frame: 12 months
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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".
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)
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).
Time frame: 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).
Time frame: 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.)
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Patients were identified for recruitment using the national VA EHR containing sociodemographic data. Other recruitment strategies included clinician and self-referrals. Potentially eligible patients were mailed study information.
| Milestone | Whole Health Team (WHT) Intervention | Primary Care Group Education (PC-GE) Intervention | Usual Care (UC) |
|---|---|---|---|
| Started | 343 | 339 | 82 |
| Completed | 316 | 307 | 81 |
| Not completed | 27 | 32 | 1 |
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).
| scores on a scale | Whole Health Team (WHT) Intervention Arm | Primary Care Group Education (PC-GE) Intervention Arm | Usual Primary Care (UPC) Arm |
|---|---|---|---|
| Change in Pain Interference | 4.91 ± 0.16 | 5.49 ± 0.18 | 5.69 ± 0.20 |
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).
| scores on a scale | Whole Health Team (WHT) Intervention Arm | Primary Care Group Education (PC-GE) Intervention Arm | Usual Primary Care (UPC) Arm |
|---|---|---|---|
| Change in Pain Severity | 5.05 ± 0.14 | 5.45 ± 0.18 | 5.63 ± 0.17 |
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.
| Scores on a scale | Whole Health Team (WHT) Intervention Arm | Primary Care Group Education (PC-GE) Intervention Arm | Usual Primary Care (UPC) Arm |
|---|---|---|---|
| Functioning (VR-12 Physical Component Score) | 28.55 ± 0.53 | 27.75 ± 0.51 | 28.08 ± 0.93 |
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.
| Scores on a scale | Whole Health Team (WHT) Intervention | Primary Care Group Education (PC-GE) Intervention | Usual Care (UC) |
|---|---|---|---|
| Quality of Life (VR-12 Mental Component Score) | 43.85 ± 0.70 | 42.74 ± 0.73 | 42.80 ± 1.15 |
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.
| scores on a scale | Whole Health Team (WHT) Intervention Arm | Primary Care Group Education (PC-GE) Intervention Arm | Usual Primary Care (UPC) Arm |
|---|---|---|---|
| PROMIS Sleep Disturbance | 25.71 ± 0.45 | 26.38 ± 0.45 | 26.35 ± 0.65 |
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.
| # of Nonpharmacological Approaches Used | Whole Health Team (WHT) Intervention Arm | Primary Care Group Education (PC-GE) Intervention Arm | Usual Primary Care (UPC) Arm |
|---|---|---|---|
| Engagement in a Greater Number of Non-pharmacological Pain Management Activities | 3.67 ± 0.11 | 3.27 ± 0.12 | 3.03 ± 0.17 |
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".
| Participants | Whole Health Team (WHT) Intervention | Primary Care Group Education (PC-GE) Intervention | Usual Care (UC) |
|---|---|---|---|
| Positive: Several days or More | 14 | 23 | 4 |
| Negative: Not at all | 265 | 249 | 75 |
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).
| Participants | Whole Health Team (WHT) Intervention Arm | Primary Care Group Education (PC-GE) Intervention Arm | Usual Primary Care (UPC) Arm |
|---|---|---|---|
| Decreased opioid usage from baseline | 27 ± 9.7 | 33 ± 12.1 | 9 ± 11.4 |
| Did not decrease opioid usage from baseline | 252 | 240 | 70 |
The total BPI score was calculated as the mean of all 11 items (range 0-10; higher scores indicate greater overall pain).
| scores on a scale | Whole Health Team (WHT) Intervention | Primary Care Group Education (PC-GE) Intervention | Usual Care (UC) |
|---|---|---|---|
| BPI Total Score | 4.95 ± 0.14 | 5.55 ± 0.16 | 5.66 ± 0.16 |
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.)
| scores on a scale | Whole Health Team (WHT) Intervention Arm | Primary Care Group Education (PC-GE) Intervention Arm | Usual Primary Care (UPC) Arm |
|---|---|---|---|
| Anxiety (GAD-7) | 6.12 ± 0.32 | 6.40 ± 0.37 | 7.01 ± 0.47 |
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).
| scores on a scale | Whole Health Team (WHT) Intervention | Primary Care Group Education (PC-GE) Intervention | Usual Care (UC) |
|---|---|---|---|
| Depression (PHQ-9) | 8.96 ± 0.27 | 9.33 ± 0.26 | 9.21 ± 0.42 |
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.
| Participants | Whole Health Team (WHT) Intervention | Primary Care Group Education (PC-GE) Intervention | Usual Care (UC) |
|---|---|---|---|
| Positive PTSD Screen (PC-PTSD-5) | 79 | 105 | 32 |
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.
| Participants | Whole Health Team (WHT) Intervention | Primary Care Group Education (PC-GE) Intervention | Usual Care (UC) |
|---|---|---|---|
| Substance Use (TAPS-2) | 35 | 32 | 7 |
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.
| scores on a scale | Whole Health Team (WHT) Intervention | Primary Care Group Education (PC-GE) Intervention | Usual Care (UC) |
|---|---|---|---|
| Patient Global Impression of Change (PGIC) | 0.95 ± 0.09 | 0.75 ± 0.10 | 0.30 ± 0.15 |
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.
| scores on a scale | Whole Health Team (WHT) Intervention | Primary Care Group Education (PC-GE) Intervention | Usual Care (UC) |
|---|---|---|---|
| Alcohol Use (AUDIT-C) | 1.36 ± 0.09 | 1.20 ± 0.08 | 1.37 ± 0.19 |
Collected over From enrollment until end of follow-up, up to 410 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Whole Health Team (WHT) Intervention Arm | 1/343 (0.3%) | 78/343 (22.7%) | 164/343 (47.8%) |
| Primary Care Group Education (PC-GE) Intervention Arm | 1/339 (0.3%) | 57/339 (16.8%) | 160/339 (47.2%) |
| Usual Primary Care (UPC) Arm | 1/82 (1.2%) | 18/82 (22%) | 38/82 (46.3%) |
| Event | Whole Health Team (WHT) Intervention Arm | Primary Care Group Education (PC-GE) Intervention Arm | Usual Primary Care (UPC) Arm |
|---|---|---|---|
| HospitalizationGeneral disorders | 78/343 | 57/339 | 18/82 |
| Event | Whole Health Team (WHT) Intervention Arm | Primary Care Group Education (PC-GE) Intervention Arm | Usual Primary Care (UPC) Arm |
|---|---|---|---|
| Emergency Department VisitGeneral disorders | 164/343 | 160/339 | 38/82 |
| Age, Continuous(Year) | Whole Health Team (WHT) Intervention Arm | Primary Care Group Education (PC-GE) Intervention Arm | Usual Primary Care (UPC) Arm | Total |
|---|---|---|---|---|
| Mean | 60.2 ± 12.8 | 60.7 ± 11.8 | 60.4 ± 12.1 | 60.5 ± 12.3 |
| Sex/Gender, Customized(Participants) | Whole Health Team (WHT) Intervention Arm | Primary Care Group Education (PC-GE) Intervention Arm | Usual Primary Care (UPC) Arm | Total |
|---|---|---|---|---|
| Male | 232 | 223 | 53 | 508 |
| Female | 111 | 116 | 29 | 256 |
| Non-Binary/Third gender | 0 | 0 | 0 | 0 |
| Prefer to self-describe | 0 | 0 | 0 | 0 |
| Transgender | 4 | 7 | 0 | 11 |
| Race (NIH/OMB)(Participants) | Whole Health Team (WHT) Intervention Arm | Primary Care Group Education (PC-GE) Intervention Arm | Usual Primary Care (UPC) Arm | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 3 | 5 | 1 | 9 |
| Asian | 7 | 10 | 0 | 17 |
| Native Hawaiian or Other Pacific Islander | 2 | 5 | 0 | 7 |
| Black or African American | 72 | 80 | 19 | 171 |
| White | 211 | 196 | 54 | 461 |
| More than one race | 33 | 29 | 4 | 66 |
| Unknown or Not Reported | 15 | 14 | 4 | 33 |
| Ethnicity (NIH/OMB)(Participants) | Whole Health Team (WHT) Intervention Arm | Primary Care Group Education (PC-GE) Intervention Arm | Usual Primary Care (UPC) Arm | Total |
|---|---|---|---|---|
| Hispanic or Latino | 47 | 42 | 13 | 102 |
| Not Hispanic or Latino | 290 | 295 | 68 | 653 |
| Unknown or Not Reported | 6 | 2 | 1 | 9 |
| Pain Interference (BPI)(scores on a scale) | Whole Health Team (WHT) Intervention Arm | Primary Care Group Education (PC-GE) Intervention Arm | Usual Primary Care (UPC) Arm | Total |
|---|---|---|---|---|
| Mean | 6.6 ± 1.9 | 6.4 ± 1.9 | 6.4 ± 1.8 | 6.5 ± 1.9 |
| Opioid use at time of enrollment(Participants) | Whole Health Team (WHT) Intervention Arm | Primary Care Group Education (PC-GE) Intervention Arm | Usual Primary Care (UPC) Arm | Total |
|---|---|---|---|---|
| No opioid usage | 255 | 255 | 60 | 570 |
| Opioid usage | 88 | 84 | 22 | 194 |
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San Francisco Veterans Affairs Medical Center