JAMA · 2026
The Veterans Affairs' Whole Health Approach for Chronic Pain Management: The wHOPE Randomized Clinical Trial.
Equivalence TrialСтатьяМногоцентровое исследованиеPragmatic Clinical TrialРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Seal Karen H, Morasco Benjamin J, Martin Aaron M, Reddy Kavitha P, Van Iseghem Theresa M, Bolton Rendelle E, Bokhour Barbara G, Murphy Jennifer, Denneson Lauren M, Esserman Denise, Buta Eugenia, Purcell Natalie, Bertenthal Daniel, Painter Jacob T, Abadjian Linda R, Moore Liliana C, Chan Allan C, McCamish Nicole, Maguen Shira, Neylan Thomas C, Gibson Carolyn J, Becker William C, wHOPE Study Group
Аннотация
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.
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.