Carneiro Adriana Munhoz, Silva Sara Lisboa Teodoro, Fernandes Fernando Dos Santos, Barretto Jainan Rodrigues, de Brito Tatiane Rodrigues, Moreno Lilian Hupfeld, Pimentel Fernando Cordeiro, Jorge Bruna Alcaire, Dos Santos Leonardo Afonso, Fernandes Ramos Matheus Rassi, Moreno Ricardo Alberto
Mood Disorders Unit, Faculty of Medicine FMUSP, University of São Paulo, São Paulo, Brazil.
Department and Institute of Psychiatry, Service of Interdisciplinary Neuromodulation (SIN), University of São Paulo Medical School, São Paulo, Brazil.
PLoS One. 2025 Aug 8;20(8):e0329006. doi: 10.1371/journal.pone.0329006. eCollection 2025.
Considered a leading contributor to the global health burden, depression is characterized by its multifaceted nature. Recognizing the limitations of pharmacological treatments, non-pharmacological alternatives have been suggested to enhance full remission and increase quality of life.
To contribute to this field, we aim to develop and investigate the efficacy of a short psychoeducational program as an adjunctive treatment for depression.
METHODS/DESIGN: We propose a single-center, prospective, crossover, single blind, randomized controlled trial, with 190 patients diagnosed with Major Depressive Disorder-MDD (DSM-5-TR), and moderate or intense severity by Hamilton Depression Rating Scale -HAMD-17. Participants will be randomly assigned to one of two arms, Treatment as usual (TAU) + Psychoeducation (n = 96) or TAU (n = 96). The psychoeducational program will consist of six weekly group sessions (6-10 participants) with each session lasting 90 minutes, covering information and techniques for identifying and coping with depression. Reduction in depressive levels, measured by the Beck Depression Inventory-BDI-II, and an increase in their level of knowledge on depression will be considered our primary outcome. Secondary outcomes, such as improvement in functionality and quality of life, will be measured by the Global Functioning Rating Scale (GAF), Clinical Global Impression Scale, and cognitive and behavioral factors by the Cognitive and Behavioral Avoidance Scale-CBAS, and Thoughts Scale Depressants-DTS (EPD).
Developing and validating a structured psychoeducational program for depression is crucial for understanding the contribution of psychoeducation for depression and to facilitate the replication of findings, if positive. If our program demonstrates efficacy-superiority compared to TAU treatment, it might present as an interesting, cost-effective alternative as an adjunctive treatment. An expansion to other modalities, including open groups, euthymic patients, and online formats, might be considered, depending on our results.
NCT06467474.
抑郁症被认为是全球健康负担的主要成因之一，具有多方面的特点。鉴于药物治疗存在局限性，人们提出了非药物替代疗法，以促进完全缓解并提高生活质量。
为推动该领域的发展，我们旨在开发并研究一种简短的心理教育项目作为抑郁症辅助治疗的疗效。
方法/设计：我们提议开展一项单中心、前瞻性、交叉、单盲、随机对照试验，招募190名被诊断为重度抑郁症（DSM-5-TR）且汉密尔顿抑郁量表（HAMD-17）评定为中度或重度的患者。参与者将被随机分配到两个组之一，即常规治疗（TAU）+心理教育组（n = 96）或TAU组（n = 96）。心理教育项目将包括每周一次的六次小组会议（每组6 - 10人），每次会议持续90分钟，内容涵盖识别和应对抑郁症的信息与技巧。以贝克抑郁量表（BDI-II）测量抑郁水平的降低以及抑郁症知识水平的提高将被视为我们的主要结果。次要结果，如功能和生活质量的改善，将通过全球功能评定量表（GAF）、临床总体印象量表进行测量，认知和行为因素将通过认知与行为回避量表（CBAS）以及抑郁性思维量表（DTS，EPD）进行测量。
开发并验证一个针对抑郁症的结构化心理教育项目对于理解心理教育对抑郁症的作用以及促进研究结果（如果是积极的）的复制至关重要。如果我们的项目与TAU治疗相比显示出疗效优越性，它可能会成为一种有趣且具有成本效益的辅助治疗替代方案。根据我们的研究结果，可能会考虑扩展到其他形式，包括开放组、病情缓解的患者以及在线形式。
NCT06467474。
