de la Vega Rocío, Yokoyama Kaylee, Daniels Kristen, Palermo Tonya M
Department of Personality, Assessment, and Psychological Treatment, Faculty of Psychology and Speech Therapy, University of Málaga, Málaga, Spain.
Instituto de Investigación Biomédica de Málaga y Plataforma en Nanomedicina (IBIMA Plataforma BIONAND), Málaga, Spain.
J Pediatr Psychol. 2024 Dec 16. doi: 10.1093/jpepsy/jsae099.
Reports of pain clinical trials evaluating psychological treatments often lack sufficient details on the potential and actual harm resulting from intervention. We aimed to understand how frequent and intense treatment reactions, conceptualized as unwanted symptoms, were in three clinical trials of digital Cognitive Behavioral Therapy (CBT) for adolescents with: (1) chronic primary pain, (2) sickle cell disease, and (3) chronic pancreatitis. We also aimed to understand any differences by demographic and clinical variables.
Analyses were conducted with 246 youths (12-18 years old) experiencing chronic pain and one of their caregivers. 66% of the total sample was female. The number, intensity, and type of treatment reactions experienced were assessed post treatment. T-tests and Chi-squared tests were conducted to explore whether certain treatment reactions were more frequent as a function of baseline or clinical characteristics.
9% of participants experienced some negative treatment reaction. The average intensity of those events was very low on a 0-3 scale (M = 0.1, SD = 0.4). There were no differences in the prevalence or intensity as a function of participant's sex, age, race, or baseline pain intensity. However, baseline anxiety [t = -2.4 (244); p < .05] and baseline pain interference [t = -2.2 (223); p < .05] were significantly higher in those who experienced negative treatment reactions.
A small number of participants reported experiencing negative treatment reactions, with a low intensity level. Those experiencing negative treatment reactions showed higher baseline anxiety and pain interference. Future research may build from our example to standardize collection of harms data in trials of psychological interventions.
评估心理治疗的疼痛临床试验报告往往缺乏关于干预潜在和实际危害的足够细节。我们旨在了解在针对以下三类青少年的数字认知行为疗法（CBT）的三项临床试验中，被概念化为不良症状的治疗反应的频率和强度如何：（1）慢性原发性疼痛，（2）镰状细胞病，以及（3）慢性胰腺炎。我们还旨在了解人口统计学和临床变量方面的任何差异。
对246名患有慢性疼痛的青少年及其一名照顾者进行了分析。总样本中66%为女性。在治疗后评估所经历的治疗反应的数量、强度和类型。进行了t检验和卡方检验，以探讨某些治疗反应是否因基线或临床特征而更频繁出现。
9%的参与者经历了一些负面治疗反应。这些事件的平均强度在0至3的量表上非常低（M = 0.1，SD = 0.4）。在患病率或强度方面，未发现因参与者的性别、年龄、种族或基线疼痛强度而存在差异。然而，经历负面治疗反应的参与者的基线焦虑[t = -2.4（244）；p <.05]和基线疼痛干扰[t = -2.2（223）；p <.05]显著更高。
少数参与者报告经历了负面治疗反应，且强度较低。经历负面治疗反应的人表现出更高的基线焦虑和疼痛干扰。未来的研究可以借鉴我们的例子，在心理干预试验中规范危害数据的收集。
