The Veterans Affairs' Whole Health Approach for Chronic Pain Management: The wHOPE Randomized Clinical Trial.

Background

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.

评估整体健康团队干预措施在VA慢性疼痛患者中的有效性，与认知行为疗法和常规护理相比较，以及评估认知行为疗法与常规护理相比在减少长期疼痛干扰方面的有效性。

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.

这项涉及美国6个退伍军人健康系统的随机临床试验在2020年9月18日至2024年1月19日期间招募了参与者。

Final follow-up occurred on January 27, 2025.

最终随访发生在2025年1月27日。

Analyses took place between April 1, 2025, and February 3, 2026.

分析工作于2025年4月1日至2026年2月3日之间进行。

Participants were patients with chronic pain receiving VA primary care.

参与者为接受美国退伍军人事务部初级保健的慢性疼痛患者。

Methods

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.

患有慢性疼痛的患者被随机分为三组（11:11:2），接受整体健康团队干预（n = 343），在小组中进行的认知行为疗法（n = 339），或常规护理（n = 82），持续12个月。

The whole health team included a primary physician or nurse practitioner, a second clinician providing nonpharmacological or integrative pain care, and a coach.

整体健康团队包括一名初级医生或执业护士，一名提供非药物或综合疼痛护理的第二临床医生，以及一名教练。

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.

该团队提供了与VA整体健康模式一致的跨学科、个性化的护理，以实现与患者个人价值观和生活目标一致的个人健康目标。

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.

主要结果是在12个月时的简短疼痛干扰量表（BPI-I）子量表得分（范围，0-10分；得分越高表示疼痛干扰越严重；最小的临床重要差异为1.0）。

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.

在764名随机分配的患者中（平均年龄[标准差]为60.5[12.3]岁；66.5%为男性），有632名（82.7%）完成了12个月的随访。

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.

在12个月时，整体健康组的疼痛干扰评分显著改善（从6.6降至4.9），与认知行为疗法组（从6.4降至5.5）（平均差异，-0.58 [97%置信区间，-1.11至-0.05]；P = .02）和常规护理组（从6.4降至5.7）（平均差异，-0.77 [99%置信区间，-1.40至-0.15]；P = .002）相比。

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).

在12个月时，认知行为疗法并未显著改善疼痛干扰评分，与常规护理相比（平均差异，-0.19 [99% 置信区间, -0.89至0.50]；P = .46）。

The most common adverse eventwas 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.

最常见的不良事件是自杀意念，发生在认知行为疗法组的患者中有15.9%，整个健康团队组为13.7%，常规护理组为13.4%。

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.

这些结果支持采用全健康团队方法，以实现对慢性疼痛的退伍军人患者在疼痛干扰方面的统计学上显著但小幅度的改善。

trial_registration

ClinicalTrials.gov Identifier: NCT04330365.

ClinicalTrials.gov 注册号：NCT04330365。