SuRxgWell: study protocol for a randomized controlled trial of telemedicine-based digital cognitive behavioral intervention for high anxiety and depression among patients undergoing elective hip and knee arthroplasty surgery.
SuRxgWell: study protocol for a randomized controlled trial of telemedicine-based digital cognitive behavioral intervention for high anxiety and depression among patients undergoing elective hip and knee arthroplasty surgery.
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情绪障碍（焦虑、抑郁）、睡眠障碍和灾难化导致手术患者术后疼痛感知增加、术后阿片类药物消耗增加、体力活动减少和资源利用率增加。心理社会障碍显著影响术后预后。不幸的是，关于围手术期心理评估和治疗的研究很少。我们建议测试数字认知行为干预（dCBI）是否可以帮助手术患者。RxWell™等dCBI是一种经证实的治疗医学患者情绪障碍的方法，如减轻炎症性肠病患者的抑郁。我们假设RxWell™对外科患者也有效。本研究旨在测试RxWell™是否可以改善原发性全髋关节置换术（THA， TKA）患者的术前情绪障碍，并随后减少术后疼痛和阿片类药物需求。我们将该试验命名为SuRxgWell试验。这是一项随机对照试验，将招募术前有焦虑和/或抑郁症状的原发性和单侧THA或TKA患者接受SuRxgWell dCBI计划，并研究其对术后结果的影响，包括术后疼痛、焦虑、抑郁、睡眠障碍和灾难。签署知情同意书后，将使用PROMIS问卷对受试者进行筛选，在短患者报告结果测量信息系统（PROMIS） 4a焦虑和/或短PROMIS 4a抑郁问卷中t分≥60分的受试者将被随机分配到常规治疗组（对照组）或认知行为干预RxWell™加常规治疗组（干预组）。对照组将获得关于如何定位工具来解决焦虑和抑郁的信息，而干预组将在手术前1个月和术后3个月访问SuRxgWell。分配比例为3:1（干预对控制）。调查人员将被蒙蔽，但接近患者和研究对象的研究协调员不会。主要结果将是手术当天的焦虑或抑郁症状，用PROMIS短表v1.0 -焦虑4a/抑郁和广泛性焦虑障碍量表（GAD-7）和患者健康问卷（PHQ-8）测量。次要终点包括测量其他与健康相关的生活质量结果，包括睡眠障碍、疲劳、参与社会角色的能力、疼痛干扰、认知功能、疼痛灾难化和身体功能。其他次要结局包括收集术前和术后疼痛评分、止痛药使用情况以及基线、手术当日、术后1、2和3个月骨科功能恢复的数据，包括疼痛灾难量表、膝关节损伤和骨关节炎结局评分（oos）和髋关节损伤和骨关节炎结局评分（HOOS）。此外，受试者将被要求每两周完成一份GAD-7和PHQ-8问卷（干预组通过RxWell™应用程序，对照组通过REDCAP应用程序）。术后并发症和资源利用的数据也将被记录。我们还将收到每月的报告，衡量随机分配到该组的每个参与者使用RxWell的情况和参与度。主要假设将用意向治疗估计值进行评估，主要结果的差异将使用独立的两样本t检验进行检验。该试验已注册到ClinicalTrials.gov数据库（NCT05658796），并得到DAPM、UPMC健康计划和NIH的支持。我们的试验将评估数字认知行为干预作为一种围手术期工具的可行性，与教育相比，可以改善骨科大手术前后的焦虑和抑郁。如果数字认知行为干预被证明是有效的，这可能具有重要的临床意义，减少慢性术后疼痛的发生率并改善预后。在线版本包含补充资料，可在10.1186/s13063-023-07634-0获得。
Mood disorders (anxiety, depression), sleep disorders, and catastrophizing lead to increased post-operative pain perception, increase in postoperative opioid consumption, decreased engagement with physical activity, and increased resource utilization in surgical patients. Psychosocial disorders significantly affect postoperative outcome. Unfortunately, studies focused on perioperative psychological assessment and treatment are scarce. We propose to test whether digital cognitive behavioral intervention (dCBI) can help surgical patients. dCBI such as RxWell™ is a proven treatment for mood disorders in medical patients such as reducing depression in patients with inflammatory bowel disease. We hypothesize that RxWell™ will also be effective in surgical patients. This study aims to test whether RxWell™ can improve preoperative mood disorders and subsequently reduce postoperative pain and opioid requirement in patients scheduled for primary total hip and knee arthroplasty (THA, TKA). We named the trial as the SuRxgWell trial. This is a randomized, controlled trial that will enroll primary and unilateral THA or TKA patients with anxiety and/or depression symptoms before surgery to receive the SuRxgWell dCBI program and investigate its impact on postoperative outcomes including postoperative pain, anxiety, depression, sleep disorder, and catastrophizing. After signing an informed consent, subjects will be screened using the PROMIS questionnaires, and subjects with a T-score of ≥ 60 on the short Patient-Reported Outcomes Measurement Information System (PROMIS) 4a Anxiety and/or short PROMIS 4a Depression questionnaires will be randomized to either usual care (control group) or the cognitive behavioral intervention, RxWell™, plus usual care (intervention group). The control group will receive information on how to locate tools to address anxiety and depression, whereas the intervention group will have access to SuRxgWell 1 month prior to surgery and up to 3 months after surgery. The allocation will be 3:1 (intervention to control). Investigators will be blinded, but research coordinators approaching patients and research subjects will not. The primary outcome will be day of surgery anxiety or depression symptoms measured with the PROMIS Short Form v1.0 -Anxiety 4a/Depression and Generalized Anxiety Disorder Measure (GAD-7) and Patient Health Questionnaire (PHQ-8). Secondary end points include measuring other health-related quality of life outcomes including sleep disturbance, fatigue, ability to participate in social roles, pain interference, cognitive function, pain catastrophizing, and physical function. Other secondary outcomes include collecting data about preoperative and postoperative pain scores, and pain medication usage, and orthopedic functional recovery at baseline, day of surgery, and 1, 2, and 3 months after the surgery with the Pain Catastrophizing Scale, the Knee injury and Osteoarthritis Outcome Score (KOOS), and Hip injury and Osteoarthritis Outcome Score (HOOS). In addition, subjects will be asked to complete a GAD-7 and PHQ-8 questionnaires bi-weekly (via the RxWell™ app for the interventional group or REDCAP for the control group). Data about postsurgical complications, and resource utilization will also be recorded. We will also receive monthly reports measuring the usage and engagement of RxWell use for each participant randomized to that arm. The primary hypotheses will be assessed with intention-to-treat estimates, and differences in primary outcome will be tested using independent two sample t-tests. This trial is registered to the ClinicalTrials.gov database (NCT05658796) and supported by the DAPM, UPMC Health Plan, and the NIH. Our trial will evaluate the feasibility of digital cognitive behavioral intervention as a perioperative tool to improve anxiety and depression before and after major orthopedic surgery in comparison to education. If digital cognitive behavioral intervention proves to be effective, this might have important clinical implications, reducing the incidence of chronic postsurgical pain and improving outcomes. The online version contains supplementary material available at 10.1186/s13063-023-07634-0.
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影响因子：
3.5
作者：
Ali, Abdulemir;Lindstrand, Anders;Flivik, Gunnar
通讯作者：
Flivik, Gunnar
DOI：
10.1016/j.arth.2021.12.006
发表时间：
2022-03
期刊：
The Journal of arthroplasty
影响因子：
--
作者：
Anthony CA;Rojas E;Glass N;Keffala V;Noiseux N;Elkins J;Brown TS;Bedard NA
通讯作者：
Bedard NA
影响因子：
2.8
作者：
Dunn, Lauren K.;Durieux, Marcel E.;Naik, Bhiken I.
通讯作者：
Naik, Bhiken I.
影响因子：
7.4
作者：
Keefe FJ;Shelby RA;Somers TJ;Varia I;Blazing M;Waters SJ;McKee D;Silva S;She L;Blumenthal JA;O'Connor J;Knowles V;Johnson P;Bradley L
通讯作者：
Bradley L
DOI：
10.1186/s13741-021-00223-2
发表时间：
2021-12-08
期刊：
Perioperative medicine (London, England)
影响因子：
--
作者：
Aspalter M;Enzmann FK;Hölzenbein TJ;Hitzl W;Primavesi F;Algayerova L;Nierlich P;Kartnig C;Seitelberger R;Linni K
通讯作者：
Linni K