N/A
N=764
Pragmatic Trial of WHT vs. PC-GE to Promote Non-Pharmacological Strategies to Treat Chronic Pain in Veterans
Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT04330365 ↗Enrolled (actual)
764
Serious AEs
20.0%
Results posted
Jun 2026
Primary outcome: Primary: Change in Pain Interference — 4.91; 5.49; 5.69 scores on a scale — p=.02
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Whole Health Team (WHT) Intervention Arm, Primary Care Group Education (PC-GE) Intervention Arm, Usual Primary Care (UPC) Arm (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- San Francisco Veterans Affairs Medical Center
- Primary completion
- Jan 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Interference |
4.91; 5.49; 5.69 | .02 sig |
| SECONDARY Change in Pain Severity |
5.05; 5.45; 5.63 | — |
| SECONDARY Functioning (VR-12 Physical Component Score) |
28.55; 27.75; 28.08 | — |
| SECONDARY Quality of Life (VR-12 Mental Component Score) |
43.85; 42.74; 42.80 | — |
| SECONDARY PROMIS Sleep Disturbance |
25.71; 26.38; 26.35 | — |
| SECONDARY Engagement in a Greater Number of Non-pharmacological Pain Management Activities |
3.67; 3.27; 3.03 | — |
| SECONDARY Suicidal Ideation |
14; 23; 4; 265; 249; 75 | — |
| SECONDARY Decreased Use of Higher-risk Pain Medications, Including Opioids or High-risk Combinations of Pain Medications (i.e., Co-prescription of Opioids and Benzodiazepines) |
27; 33; 9; 252; 240; 70 | — |
| SECONDARY BPI Total Score |
4.95; 5.55; 5.66 | — |
| SECONDARY Anxiety (GAD-7) |
6.12; 6.40; 7.01 | — |
| SECONDARY Depression (PHQ-9) |
8.96; 9.33; 9.21 | — |
| SECONDARY Positive PTSD Screen (PC-PTSD-5) |
79; 105; 32 | — |
| SECONDARY Substance Use (TAPS-2) |
35; 32; 7 | — |
| SECONDARY Patient Global Impression of Change (PGIC) |
0.95; 0.75; 0.30 | — |
| SECONDARY Alcohol Use (AUDIT-C) |
1.36; 1.20; 1.37 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04330365). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.