Carvalho Sérgio A, Trindade Inês A, Duarte Joana, Menezes Paulo, Patrão Bruno, Nogueira Maria Rita, Guiomar Raquel, Lapa Teresa, Pinto-Gouveia José, Castilho Paula
University of Coimbra, Center for Research in Neuropsychology and Cognitive Behavioral Intervention, Coimbra, Portugal.
Lund University, Department of Psychology, Lund, Sweden.
Front Psychol. 2021 Mar 9;12:630766. doi: 10.3389/fpsyg.2021.630766. eCollection 2021.
Chronic pain (CP) has serious medical and social consequences and leads to economic burden that threatens the sustainability of healthcare services. Thus, optimized management of pain tools to support CP patients in adjusting to their condition and improving their quality of life is timely. Although acceptance and commitment therapy (ACT) is considered an evidence-based psychological approach for CP, evidence for the efficacy of online-delivered ACT for CP is still scarce. At the same time, studies suggest that self-compassion mediates the change in disability and psychopathological symptoms in ACT interventions for CP, although self-compassion is not a specific target in ACT. Thus, an explicit focus on self-compassion might increase the efficacy of ACT interventions for CP, although this hypothesis has not been tested. This study aims to develop an eHealth ACT and compassion-based self-management intervention for CP, the iACTwithPain, and to compare its efficacy in improving health outcomes to a similar ACT-only intervention and a medical TAU group.
The eHealth platform that will host the interventions will be developed using a flat design identity and will be interactive. The iACTwithPain intervention will comprise eight weekly self-management sessions and will be developed taking into consideration the psychological flexibility model applied to CP, with the addition of explicit compassion-based components. To analyze whether the iACTwithPain intervention will present superiority in improving CP's impact and related health markers over the two other conditions, this study will follow an RCT design with three arms. CP patients will be recruited through direct contact with patient associations and healthcare services and a national press release in Portugal. Outcome measurement will be conducted at baseline, post-intervention and at 3- and 6-month follow-ups. The interventions' acceptability will also be assessed.
The iACTwithPain intervention is expected to improve CP patients' psychosocial functioning, quality of life, and empowerment, by promoting adaptive disease management and regulation of pain-related internal experiences. Results will contribute to a better understanding on the pertinence of adding compassion elements to ACT for CP and to reach an optimized intervention for CP.
This trial has been registered at ClinicalTrials.Gov (NCT04200183; 16 December 2019; https://clinicaltrials.gov/ct2/show/NCT04200183). The current manuscript comprises the first version of this clinical trial's protocol.
慢性疼痛（CP）会产生严重的医学和社会后果，并导致经济负担，威胁到医疗服务的可持续性。因此，及时优化疼痛管理工具以支持CP患者适应病情并提高生活质量十分必要。尽管接纳与承诺疗法（ACT）被认为是一种针对CP的循证心理疗法，但关于在线提供ACT治疗CP疗效的证据仍然很少。同时，研究表明自我同情在ACT干预CP过程中调节残疾和心理病理症状的变化，尽管自我同情并非ACT的特定目标。因此，明确关注自我同情可能会提高ACT干预CP的疗效，尽管这一假设尚未得到验证。本研究旨在开发一种针对CP的基于电子健康ACT和同情的自我管理干预措施——iACTwithPain，并将其改善健康结果的疗效与类似的仅ACT干预措施和药物常规治疗组进行比较。
将使用平面设计标识开发承载干预措施的电子健康平台，并使其具有交互性。iACTwithPain干预措施将包括为期八周的自我管理课程，并将考虑应用于CP的心理灵活性模型进行开发，同时增加明确的基于同情的成分。为了分析iACTwithPain干预措施在改善CP影响和相关健康指标方面是否比其他两种情况更具优势，本研究将采用三臂随机对照试验设计。CP患者将通过与患者协会和医疗服务机构直接联系以及在葡萄牙发布全国新闻稿来招募。将在基线、干预后以及3个月和6个月随访时进行结果测量。还将评估干预措施的可接受性。
iACTwithPain干预措施有望通过促进适应性疾病管理和调节与疼痛相关的内在体验，改善CP患者的心理社会功能、生活质量和自我效能感。研究结果将有助于更好地理解在ACT治疗CP时加入同情元素的相关性，并找到针对CP的优化干预措施。
本试验已在ClinicalTrials.Gov注册（NCT04200183；2019年12月16日；https://clinicaltrials.gov/ct2/show/NCT04200183）。本手稿包含该临床试验方案的第一版。
