Lorente-Català Rosa, Font-Furnieles Pablo, Escriva-Sanchis Raquel, Bertó-García Clara, Vera-Albero Pere, García-Palacios Azucena
Department of Basic and Clinical Psychology, and Psychobiology, Universitat Jaume I, Castellon, Spain.
Foundation for the Promotion of Health and Biomedical Research of the Valencian Community. (FISABIO), Valencia, Spain.
Internet Interv. 2024 Apr 20;36:100742. doi: 10.1016/j.invent.2024.100742. eCollection 2024 Jun.
Depression is already the leading psychological disability around the world, impairing daily life, well-being, and social functioning and leading to personal and social costs. Despite the effectiveness of Evidence-Based Psychological Practices (EBPP), a significant percentage of depressive individuals remain untreated, especially in Primary Care (PC) settings in Spain. There are numerous barriers that limit access to EBPPs, including high costs, professional training, and adherence problems. Information and Communication Technologies (ICTs) offer a cost-effective way to disseminate and scale EBPPs to address these barriers. The iCBT program Smiling is Fun has been demonstrated to be a cost-effective treatment for depression in various Randomized Control Trials. However, adherence and implementation problems in real-world settings need to be addressed. Implementation research can help evaluate these challenges by identifying facilitators and barriers to the implementation process in PC. In this regard, including human support has been pointed out as a possible key factor in addressing the population's mental health needs and promoting treatment adherence.
The current study aims to examine the effectiveness, adherence rates, and implementation process of Smiling is Fun to address depression in a PC setting considering the influence of telephone support vs no support.
The proposed research is a Hybrid Effectiveness-Implementation Type I study, with a two-armed randomized controlled design, which will test a clinical intervention for major depressive disorder while gathering information on its implementation in a real-world setting. The study will include adult patients with mild to moderate symptoms of depression. Participants will be randomly assigned to one of two groups: self-applied psychotherapy or self-applied psychotherapy with psychotherapeutic telephone support. The trial will recruit 110 patient participants, with a loss-to-follow-up rate of 30 %.
A study protocol for a hybrid effectiveness-implementation study is presented with the aim to assess the implementation of Smiling is Fun for the treatment of depression in PC. The study evaluates the influence of telephone support during a self-administered intervention compared to unguided self-administration. The main goal is to address the barriers and facilitators of the implementation process and to promote treatment adherence. Ultimately, the results of the study could help in the uptake of sustainable resources so that the population could gain better access to psychological interventions in mental health services.
ClinicalTrials.gov; NCT06230237.
抑郁症已是全球主要的心理残疾问题，损害日常生活、幸福感和社会功能，并导致个人和社会成本。尽管循证心理实践（EBPP）有效，但仍有相当比例的抑郁症患者未得到治疗，尤其是在西班牙的初级保健（PC）机构中。存在许多限制获得EBPP的障碍，包括高成本、专业培训和依从性问题。信息通信技术（ICT）提供了一种经济有效的方式来传播和推广EBPP，以克服这些障碍。iCBT项目“微笑很有趣”在各种随机对照试验中已被证明是一种治疗抑郁症的经济有效方法。然而，现实环境中的依从性和实施问题需要解决。实施研究可以通过识别初级保健中实施过程的促进因素和障碍来帮助评估这些挑战。在这方面，提供人力支持已被指出是满足人群心理健康需求和促进治疗依从性的一个可能关键因素。
本研究旨在考察“微笑很有趣”在考虑电话支持与无支持影响的情况下，在初级保健环境中治疗抑郁症的有效性、依从率和实施过程。
拟进行的研究是一项混合有效性-实施I型研究，采用双臂随机对照设计，将测试针对重度抑郁症的临床干预措施，同时收集其在现实环境中实施情况的信息。该研究将纳入有轻度至中度抑郁症状的成年患者。参与者将被随机分配到两组之一：自我实施心理治疗或有心理治疗电话支持的自我实施心理治疗。该试验将招募110名患者参与者，失访率为30%。
本文介绍了一项混合有效性-实施研究的方案，旨在评估“微笑很有趣”在初级保健中治疗抑郁症的实施情况。该研究评估了与无指导的自我管理相比，在自我管理干预期间电话支持的影响。主要目标是解决实施过程的障碍和促进因素，并促进治疗依从性。最终，研究结果有助于采用可持续资源，以便人群能够更好地获得心理健康服务中的心理干预。
ClinicalTrials.gov；NCT06230237。
