Lasalvia Antonio, Bodini Luca, Cristofalo Doriana, Fin Veronica, Yanos Philip T, Bonetto Chiara
Section of Psychiatry, Department of Neuroscience, Biomedicine and Movement Sciences, University of Verona, Policlinico "G.B. Rossi", P.Le Scuro, 10 37134, Verona, Italy.
UOC Psichiatria, Azienda Ospedaliera Universitaria Integrata (AOUI) Di Verona, Verona, Italy.
Trials. 2025 Jan 31;26(1):35. doi: 10.1186/s13063-025-08739-4.
Self-stigma refers to the process whereby individuals with mental disorders internalize negative societal attitudes and misconceptions about mental health conditions, potentially affecting their sense of self-worth and identity. This internalization can significantly impact various aspects of life, including treatment engagement, personal relationships, and overall well-being. Narrative Enhancement and Cognitive Therapy (NECT) was developed in the United States to counteract self-stigma and has been supported by multiple randomized controlled trials. However, NECT has not yet been implemented in Italy or within a public mental health system grounded in community psychiatry. This study aims to evaluate the efficacy and feasibility of the Italian version of the NECT within the public mental health sector in a large part of North-East Italy.
This pragmatic, multisite, superiority, randomized, wait-list controlled trial with two parallel arms will recruit over four hundred patients with severe mental disorders from 26 public community-based mental health centers in North-East Italy. The experimental intervention, NECT, consists of 20 group-based sessions to reduce self-stigma. The study will assess NECT's impact on several psychological dimensions, including self-stigma levels (primary outcome), self-esteem, hope, empowerment, recovery perception, mental well-being, and stigma stress (secondary outcomes). Feasibility will be evaluated by collecting data on participant adherence and treatment implementation, including eligibility screening, participation rates, intervention completion, exposure levels, and reasons for dropout.
The findings of this research are expected to contribute to the understanding of effective treatments for patients with mental disorders, particularly those burdened by high levels of self-stigma, and to improve their recovery outcomes.
ClinicalTrials.gov; Identifier: NCT06567145.
自我污名化是指患有精神障碍的个体将社会对心理健康状况的负面态度和误解内化的过程，这可能会影响他们的自我价值感和身份认同。这种内化会对生活的各个方面产生重大影响，包括治疗参与度、人际关系和整体幸福感。叙事增强与认知疗法（NECT）是在美国开发的，用于对抗自我污名化，并得到了多项随机对照试验的支持。然而，NECT尚未在意大利或基于社区精神病学的公共心理健康系统中实施。本研究旨在评估意大利版NECT在意大利东北部大部分地区的公共心理健康部门中的疗效和可行性。
这项务实、多中心、优效性、随机、等待列表对照试验设有两个平行组，将从意大利东北部26个基于社区的公共心理健康中心招募400多名患有严重精神障碍的患者。实验性干预措施NECT包括20次基于小组的课程，以减少自我污名化。该研究将评估NECT对几个心理维度的影响，包括自我污名化水平（主要结果）、自尊、希望、赋权、康复认知、心理健康和污名压力（次要结果）。将通过收集关于参与者依从性和治疗实施的数据来评估可行性，包括资格筛查、参与率、干预完成情况、暴露水平和退出原因。
本研究的结果预计将有助于理解针对精神障碍患者，特别是那些承受高度自我污名化负担的患者的有效治疗方法，并改善他们的康复结果。
ClinicalTrials.gov；标识符：NCT06567145。
