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远程医疗正念干预慢性疼痛:LAMP 随机临床试验。

Telehealth Mindfulness-Based Interventions for Chronic Pain: The LAMP Randomized Clinical Trial.

机构信息

VA Health Systems Research Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, Minnesota.

University of Minnesota Medical School, Minneapolis.

出版信息

JAMA Intern Med. 2024 Oct 1;184(10):1163-1173. doi: 10.1001/jamainternmed.2024.3940.

Abstract

IMPORTANCE

Although mindfulness-based interventions (MBIs) are evidence-based treatments for chronic pain and comorbid conditions, implementing them at scale poses many challenges, such as the need for dedicated space and trained instructors.

OBJECTIVE

To examine group and self-paced, scalable, telehealth MBIs, for veterans with chronic pain, compared to usual care.

DESIGN, SETTING, AND PARTICIPANTS: This was a randomized clinical trial of veterans with moderate to severe chronic pain, recruited from 3 Veterans Affairs facilities from November 2020 to May 2022. Follow-up was completed in August 2023.

INTERVENTIONS

Two 8-week telehealth MBIs (group and self-paced) were compared to usual care (control). The group MBI was done via videoconference with prerecorded mindfulness education and skill training videos by an experienced instructor, accompanied by facilitated discussions. The self-paced MBI was similar but completed asynchronously and supplemented by 3 individual facilitator calls.

MAIN OUTCOMES AND MEASURES

The primary outcome was pain-related function using the Brief Pain Inventory interference scale at 3 time points: 10 weeks, 6 months, and 1 year. Secondary outcomes included biopsychosocial outcomes: pain intensity, physical function, anxiety, fatigue, sleep disturbance, participation in social roles and activities, depression, patient ratings of improvement of pain, and posttraumatic stress disorder.

RESULTS

Among 811 veterans randomized (mean [SD] age, 54.6 [12.9] years; 387 [47.7%] women), 694 participants (85.6%) completed the trial. Averaged across all 3 time points, pain interference scores were significantly lower for both MBIs compared to usual care (group MBI vs control difference: -0.4 [95% CI, -0.7 to -0.2]; self-paced vs control difference: -0.7 [95% CI, -1.0 to -0.4]). Additionally, both MBI arms had significantly better scores on the following secondary outcomes: pain intensity, patient global impression of change, physical function, fatigue, sleep disturbance, social roles and activities, depression, and posttraumatic stress disorder. Both group and self-paced MBIs did not significantly differ from one another. The probability of 30% improvement from baseline compared to control was greater for group MBI at 10 weeks and 6 months, and for self-paced MBI, at all 3 time points.

CONCLUSIONS AND RELEVANCE

In this randomized clinical trial, scalable telehealth MBIs improved pain-related function and biopsychosocial outcomes compared to usual care among veterans with chronic pain. Relatively low-resource telehealth-based MBIs could help accelerate and improve the implementation of nonpharmacological pain treatment in health care systems.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT04526158.

摘要

重要性

虽然基于正念的干预(MBIs)是慢性疼痛和合并症的循证治疗方法,但大规模实施它们存在许多挑战,例如需要专用空间和经过培训的讲师。

目的

研究针对慢性疼痛退伍军人的小组和自我 paced、可扩展、远程医疗 MBIs 与常规护理相比的效果。

设计、地点和参与者:这是一项针对慢性疼痛中度至重度退伍军人的随机临床试验,于 2020 年 11 月至 2022 年 5 月从 3 家退伍军人事务设施招募参与者。随访于 2023 年 8 月完成。

干预措施

两种 8 周的远程医疗 MBIs(小组和自我 paced)与常规护理(对照组)进行比较。小组 MBI 通过视频会议进行,由经验丰富的讲师提供预先录制的正念教育和技能培训视频,并辅以促进性讨论。自我 paced MBI 类似,但异步完成,并辅以 3 次单独的主持人电话。

主要结果和措施

主要结果是使用Brief Pain Inventory 干扰量表在 3 个时间点(10 周、6 个月和 1 年)评估疼痛相关功能。次要结果包括生物心理社会结果:疼痛强度、身体功能、焦虑、疲劳、睡眠障碍、社会角色和活动参与度、抑郁、患者对疼痛改善的评分和创伤后应激障碍。

结果

在 811 名随机分组的退伍军人中(平均[标准差]年龄,54.6[12.9]岁;387[47.7%]为女性),有 694 名参与者(85.6%)完成了试验。在所有 3 个时间点,与常规护理相比,两种 MBI 的疼痛干扰评分均显著降低(小组 MBI 与对照组的差异:-0.4[95%CI,-0.7 至-0.2];自我 paced 与对照组的差异:-0.7[95%CI,-1.0 至-0.4])。此外,两种 MBI 手臂在以下次要结果上的评分均显著更好:疼痛强度、患者整体印象变化、身体功能、疲劳、睡眠障碍、社会角色和活动、抑郁和创伤后应激障碍。小组和自我 paced MBI 之间没有显著差异。与对照组相比,10 周和 6 个月时小组 MBI 和所有 3 个时间点时自我 paced MBI 的基线改善 30%的概率更高。

结论和相关性

在这项随机临床试验中,与常规护理相比,可扩展的远程医疗 MBIs 改善了慢性疼痛退伍军人的疼痛相关功能和生物心理社会结果。相对资源较少的基于远程医疗的 MBIs 可能有助于加速和改善医疗系统中非药物疼痛治疗的实施。

试验注册

ClinicalTrials.gov 标识符:NCT04526158。

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