Allen Kelli D, Beauchamp Tyler, Rini Christine, Keefe Francis J, Bennell Kim L, Cleveland Rebecca J, Grimm Kimberlea, Huffman Katie, Hu David G, Santana Andres, Saxena Beem Shruti, Walker Julie, Sheikh Saira Z
Department of Medicine, Division of Rheumatology, Allergy and Immunology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Thurston Arthritis Research Center, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
BMC Rheumatol. 2021 Jun 17;5(1):20. doi: 10.1186/s41927-021-00191-6.
BACKGROUND: Patients with Systemic Lupus Erythematosus (SLE) often experience pain and other symptoms that negatively impact quality of life. Interventions that enhance the use of behavioral and cognitive coping strategies may lead to improved outcomes among patients with SLE. Pain coping skills training (PCST) programs have been shown to improve outcomes among patients with other rheumatic conditions, but there have been no trials of PCST among patients with SLE. This study was a preliminary assessment of the feasibility and efficacy of painTRAINER, an automated, internet-based PCST program, among patients with SLE. METHODS: Participants (n = 60) with SLE from one health care system were randomly assigned with equal allocation to painTRAINER or a wait list control group. PainTRAINER involves 8 modules; participants were instructed to complete one module weekly, along with practice activities for each cognitive or behavioral coping skill. Outcome measures were assessed at baseline and 9-week follow-up, including the Pain Catastrophizing Scale, PROMIS Subscales (Pain Interference, Physical Function, Sleep Disturbance, Anxiety, Depression, Fatigue and Participation), and the LupusPRO questionnaire. Mean changes in outcomes from baseline to follow up and Cohen's d effect sizes were computed. RESULTS: Effect sizes for the painTRAINER group (relative to the wait list group) were small, with changes being greatest for the PROMIS Depression score (d = - 0.32). Among those randomized to the painTRAINER group, 50% accessed the program ("painTRAINER users"). Most of those who did not access the program stated that they did not receive instructions via email. Effect sizes for "painTRAINER users" (relative to wait list) were larger than for the whole painTRAINER group: Pain Catastrophizing d = - 0.60, PROMIS Pain Interference d = - 0.3., PROMIS Depression d = - 0.44, LupusPRO Health-Related Quality of Life d = 0.30. CONCLUSIONS: PainTRAINER users reported meaningful improvements in multiple physical and psychological outcomes, supporting the potential of PCST programs to benefit individuals with SLE. However, strategies are needed to improve engagement with the program and tailor content to comprehensively address key SLE symptoms and challenges. TRIAL REGISTRATION: NCT03933839 , May 1, 2019.
背景：系统性红斑狼疮（SLE）患者常经历疼痛及其他对生活质量产生负面影响的症状。增强行为和认知应对策略使用的干预措施可能会改善SLE患者的预后。疼痛应对技能训练（PCST）项目已被证明能改善其他风湿性疾病患者的预后，但尚未在SLE患者中进行过PCST试验。本研究是对一款自动化的基于互联网的PCST项目——painTRAINER在SLE患者中的可行性和疗效进行的初步评估。 方法：来自一个医疗系统的60名SLE参与者被随机等分为painTRAINER组或等待列表对照组。painTRAINER包含8个模块；参与者被要求每周完成一个模块，并进行每种认知或行为应对技能的练习活动。在基线和9周随访时评估结果指标，包括疼痛灾难化量表、PROMIS子量表（疼痛干扰、身体功能、睡眠障碍、焦虑、抑郁、疲劳和参与度）以及狼疮PRO问卷。计算从基线到随访结果的平均变化及科恩d效应量。 结果：painTRAINER组（相对于等待列表组）的效应量较小，其中PROMIS抑郁评分变化最大（d = -0.32）。在随机分配到painTRAINER组的参与者中，50%使用了该项目（“painTRAINER使用者”）。大多数未使用该项目的人表示他们未收到电子邮件指示。“painTRAINER使用者”（相对于等待列表）的效应量大于整个painTRAINER组：疼痛灾难化d = -0.60，PROMIS疼痛干扰d = -0.3，PROMIS抑郁d = -0.44，狼疮PRO健康相关生活质量d = 0.30。 结论：painTRAINER使用者报告在多个身体和心理结果方面有显著改善，支持了PCST项目使SLE患者受益的潜力。然而，需要采取策略来提高对该项目的参与度，并调整内容以全面解决SLE的关键症状和挑战。 试验注册：NCT03933839，2019年5月1日。
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