IMPORTANCE: The US Department of Veterans Affairs (VA) Whole Health approach was congressionally mandated in 2016 for patients with chronic pain receiving care in VA hospitals, but no randomized clinical trials have tested its benefits.
OBJECTIVE: To evaluate the effectiveness of a whole health team intervention in VA patients with chronic pain compared with cognitive behavioral therapy and with usual care, and to evaluate the effectiveness of cognitive behavioral therapy compared with usual care in reducing long-term pain interference.
DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial involving 6 VA health systems in the US enrolled participants between September 18, 2020, and January 19, 2024. Final follow-up occurred on January 27, 2025. Analyses took place between April 1, 2025, and February 3, 2026. Participants were patients with chronic pain receiving VA primary care.
INTERVENTIONS: Patients with chronic pain were randomized (11:11:2) to receive a whole health team intervention (n = 343), cognitive behavioral therapy for chronic pain delivered in group sessions (n = 339), or usual care (n = 82) for 12 months. The whole health team included a primary physician or nurse practitioner, a second clinician providing nonpharmacological or integrative pain care, and a coach. The team provided interdisciplinary, individualized care consistent with the VA Whole Health model to attain personal health goals aligned with patients' personal values and life goals.
MAIN OUTCOMES AND MEASURES: The primary outcome was the Brief Pain Inventory interference (BPI-I) subscale score (range, 0-10 points; higher scores indicate worse interference from pain; minimal clinically important difference, 1.0) at 12 months.
RESULTS: Of 764 randomized patients (mean [SD] age, 60.5 [12.3] years; 66.5% were men), 632 (82.7%) completed 12-month follow-up. At 12 months, the whole health group had significantly improved pain interference scores (from 6.6 to 4.9) compared with the cognitive behavioral therapy (from 6.4 to 5.5) (mean difference, -0.58 [97% CI, -1.11 to -0.05]; P = .02) and usual care (from 6.4 to 5.7) (mean difference, -0.77 [99% CI, -1.40 to -0.15]; P = .002) groups. At 12 months, cognitive behavioral therapy did not improve pain interference scores significantly more than usual care (mean difference, -0.19 [99% CI, -0.89 to 0.50]; P = .46). The most common adverse event was suicidal ideation, which occurred in 15.9% of patients in the cognitive behavioral therapy group, 13.7% in the whole health team group, and 13.4% in the usual care group.
CONCLUSIONS AND RELEVANCE: These results support use of the whole health team approach to attain a statistically significant but small improvement in pain interference in VA patients with chronic pain.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04330365.
| Discipline Area | Score |
|---|---|
| Physician |  |
Physician rater
The article does not explain this complex intervention well.
Physician rater
This study appears to support a "whole team" approach to V.A. patients with chronic pain. Although the authors claim that the findings support that clinicians use this approach, they did not use an intention-to-treat analysis. Less than 2/3 of those assigned to the whole team approach had full adherence, yet the results were analyzed via a per-protocol analysis. I am not confident that the findings were due to the approach itself.
Physician rater
Although I applaud the trial design having seen this method utilized elsewhere, the effect size between groups, while statistically significant, was below the stated cutoff needed to identify clinical significance. I fear that this approach will be tough to justify from a resource allocation standpoint given the limited marginal utility compared with usual care.
Physician rater
Whether this intervention could be disseminated more broadly is uncertain.
, McMaster University