通过视频会议对神经纤维瘤病患者进行身心治疗：一项随机对照试验。
Mind-body therapy via videoconferencing in patients with neurofibromatosis: An RCT.
作者信息
Vranceanu Ana-Maria, Riklin Eric, Merker Vanessa L, Macklin Eric A, Park Elyse R, Plotkin Scott R
机构信息
From the Behavioral Medicine Service (A.-M.V.), Benson-Henry Institute for Mind Body Medicine (E.R., E.R.P.), and Department of Neurology and Cancer Center (V.L.M., S.R.P.), Massachusetts General Hospital, Boston; Biostatistics Center (E.A.M.), Massachusetts General Hospital and Harvard Medical School, Boston, MA.
出版信息
Neurology. 2016 Aug 23;87(8):806-14. doi: 10.1212/WNL.0000000000003005. Epub 2016 Jul 22.
OBJECTIVE
To test, within a single-blind randomized controlled trial, the feasibility, acceptability, efficacy, and durability of a mind-body program (the Relaxation Response Resiliency Program for neurofibromatosis [3RP-NF]) vs an attention placebo control (Health Enhancement Program for NF [HEP-NF]), both delivered via group videoconferencing.
METHODS
Sixty-three patients completed baseline assessments and were randomized. Primary outcomes were physical health and psychological quality of life (QoL), measured by the WHOQOL-BREF (World Health Organization QoL abbreviated instrument). Secondary outcomes were social relations and environment QoL, depression, anxiety, pain intensity, and pain interference.
RESULTS
Sixty-three participants completed the intervention (100%) and 52 the 6-month follow-up (82.5%). Acceptability was 4.1 (5-point scale). Patients in the 3RP-NF showed greater improvement in physical health QoL (7.69; 95% confidence interval [CI]: 0.29-15.10; p = 0.040), psychological QoL (5.57; 95% CI: 0.17-11.34; p = 0.056), social relations QoL (10.95; 95% CI: 1.57-20.31; p = 0.021), environment QoL (8.02; 95% CI: 2.57-13.48; p = 0.005), and anxiety (-2.32; 95% CI: -3.96 to 0.69; p = 0.006) compared to those in HEP-NF, and gains were maintained at follow-up. Patients in the 3RP-NF did not improve more than those in HEP-NF on depression, with both groups showing improvement. Patients in the 3RP-NF with baseline pain ≥5 of 10 showed improvement in pain intensity from baseline to posttest (1.30; 95% CI: -2.26 to -0.34; p = 0.009) with effects maintained at follow-up; this improvement was not greater than that in HEP-NF. There were more treatment responders in the 3RP-NF group (p < 0.05).
CONCLUSIONS
The 3RP-NF delivered via videoconferencing was highly feasible and accepted by patients, and resulted in sustained improvement in QoL.
CLASSIFICATION OF EVIDENCE
This study provides Class II evidence that for patients with NF, a mind-body program is superior to an attention placebo control in improving QoL.
目的
在一项单盲随机对照试验中，测试一种身心计划（神经纤维瘤病放松反应恢复力计划[3RP-NF]）与注意力安慰剂对照（神经纤维瘤病健康促进计划[HEP-NF]）通过群组视频会议实施的可行性、可接受性、疗效和持续性。
方法
63名患者完成了基线评估并被随机分组。主要结局是身体健康和心理生活质量（QoL），通过世界卫生组织生活质量简表（WHOQOL-BREF）进行测量。次要结局是社会关系和环境生活质量、抑郁、焦虑、疼痛强度和疼痛干扰。
结果
63名参与者完成了干预（100%），52名完成了6个月随访（82.5%）。可接受性评分为4.1（5分制）。与HEP-NF组患者相比，3RP-NF组患者在身体健康生活质量（7.69；95%置信区间[CI]：0.29 - 15.10；p = 0.040）、心理生活质量（5.57；95% CI：0.17 - 11.34；p = 0.056）、社会关系生活质量（10.95；95% CI：1.57 - 20.31；p = 0.021）、环境生活质量（8.02；95% CI：2.57 - 13.48；p = 0.005）和焦虑（-2.32；95% CI：-3.96至0.69；p = 0.006）方面有更大改善，且这些改善在随访时得以维持。3RP-NF组患者在抑郁方面的改善并不比HEP-NF组患者更大，两组均有改善。基线疼痛≥10分中5分的3RP-NF组患者从基线到测试后疼痛强度有所改善（1.30；95% CI：-2.26至-0.34；p = 0.009），且效果在随访时维持；这种改善并不比HEP-NF组更大。3RP-NF组有更多治疗反应者（p < 0.05）。
结论
通过视频会议实施的3RP-NF具有高度可行性且患者可接受，并能使生活质量持续改善。
证据分级
本研究提供了II级证据，表明对于神经纤维瘤病患者，一种身心计划在改善生活质量方面优于注意力安慰剂对照。
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