García-Torres Francisco, Gómez-Solís Ángel, Rubio García Sebastián, Castillo-Mayén Rosario, González Ruíz-Ruano Verónica, Moreno Eliana, Moriana Juan Antonio, Luque-Salas Bárbara, Jaén-Moreno María José, Cuadrado-Hidalgo Fátima, Gálvez-Lara Mario, Jablonski Marcin, Rodríguez-Alonso Beatriz, Aranda Enrique
Department of Psychology, University of Córdoba, Córdoba, Spain.
Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Córdoba, Spain.
Front Psychol. 2022 May 18;13:871929. doi: 10.3389/fpsyg.2022.871929. eCollection 2022.
Psychological flexibility is a key concept of acceptation and commitment therapy (ACT). This factor has been linked with psychological wellbeing and associated factors, such as quality of life, in cancer patients. These and other positive results of acceptation and commitment therapy in cancer patients found in previous research could be enhanced by using mhealth tools. A three-arm randomized superiority clinical trial, with a pre-post-follow-up repeated measures intergroup design with a 1:1:1 allocation ratio is proposed. A hundred and twenty cancer patients will be randomly assigned to one of the following interventions: (1) face-to-face ACT + mobile application (app), (2) face-to-face ACT, and (3) Waitlist control group. The primary expected outcome is to observe significant improvements in psychological flexibility acceptance and action questionnaire- II (AAQ-II) in the face-to-face ACT + app group, after comparing baseline and post-treatment scores, and the scores will remain stable in the two assessment points, 3 and 6 months after the intervention. Secondary expected outcomes are significant increasing scores in quality of life (EORTC QLQ C-30) and post-traumatic-growth (PTGI-SF), and significant decreasing scores in anxiety and depression (HADS), insomnia (ISI) and fatigue (BFI) at the same assessment points. Also, it is expected that the scores of this group will be higher than the scores of the face-to-face ACT group and the waitlist control group. This study aims to assess the efficacy of a combined intervention (face-to face ACT + app) for psychological flexibility and associated symptoms in cancer patients. The results of this protocol may help to consider the use of acceptation and commitment therapy and mhealth applications in cancer settings as a valid therapeutic choice.
[www.ClinicalTrials.gov], identifier [NCT05126823].
心理灵活性是接纳与承诺疗法（ACT）的关键概念。这一因素与癌症患者的心理健康及相关因素（如生活质量）有关。先前研究发现，接纳与承诺疗法在癌症患者中取得的这些及其他积极成果，可通过使用移动健康工具得到强化。拟进行一项三臂随机优势临床试验，采用组间前后随访重复测量设计，分配比例为1:1:1。120名癌症患者将被随机分配至以下干预措施之一：（1）面对面ACT + 移动应用程序（app），（2）面对面ACT，（3）等待列表对照组。主要预期结果是，在比较基线和治疗后分数后，观察面对面ACT + app组在心理灵活性接纳与行动问卷-II（AAQ-II）上有显著改善，且在干预后3个月和6个月的两个评估点分数保持稳定。次要预期结果是在相同评估点，生活质量（EORTC QLQ C-30）和创伤后成长（PTGI-SF）分数显著增加，焦虑和抑郁（HADS）、失眠（ISI）和疲劳（BFI）分数显著降低。此外，预计该组分数将高于面对面ACT组和等待列表对照组。本研究旨在评估联合干预（面对面ACT + app）对癌症患者心理灵活性及相关症状的疗效。本方案的结果可能有助于考虑在癌症治疗中使用接纳与承诺疗法和移动健康应用程序作为一种有效的治疗选择。
[www.ClinicalTrials.gov]，标识符 [NCT05126823]
