Assessing the effectiveness and the feasibility of a group-based treatment for self-stigma in people with mental disorders in routine mental health services in North-East Italy: study protocol for a pragmatic multisite randomized controlled trial.

IF 2 4区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Trials Pub Date : 2025-01-31 DOI:10.1186/s13063-025-08739-4
Antonio Lasalvia, Luca Bodini, Doriana Cristofalo, Veronica Fin, Philip T Yanos, Chiara Bonetto
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引用次数: 0

Abstract

Background: 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.

Methods and analysis: 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.

Discussion: 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.

Trial registration: ClinicalTrials.gov; Identifier: NCT06567145.

评估意大利东北部常规精神卫生服务中精神障碍患者自我耻辱的群体治疗的有效性和可行性:一项实用的多地点随机对照试验的研究方案。
背景:自我耻辱感是指精神障碍患者内化社会对精神健康状况的负面态度和误解,从而影响其自我价值感和认同感的过程。这种内化可以显著影响生活的各个方面,包括治疗参与、人际关系和整体幸福感。叙事增强和认知疗法(NECT)是在美国发展起来的,旨在消除自我耻辱,并得到了多个随机对照试验的支持。然而,NECT尚未在意大利或在以社区精神病学为基础的公共精神卫生系统内实施。本研究旨在评估意大利东北部大部分地区公共精神卫生部门的意大利版NECT的有效性和可行性。方法和分析:这项实用的、多地点的、优越性的、随机的、等待名单对照试验将从意大利东北部26个公共社区精神卫生中心招募400多名严重精神障碍患者。实验干预,NECT,包括20个小组为基础的会议,以减少自我耻辱。本研究将评估NECT对几个心理维度的影响,包括自我耻辱感水平(主要结果)、自尊、希望、赋权、康复感知、心理健康和耻辱感压力(次要结果)。可行性将通过收集参与者依从性和治疗实施的数据来评估,包括资格筛选、参与率、干预完成情况、暴露水平和退出原因。讨论:本研究的结果有望有助于了解精神障碍患者的有效治疗方法,特别是那些背负高度自我耻辱的患者,并改善他们的康复结果。试验注册:ClinicalTrials.gov;标识符:NCT06567145。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Trials
Trials 医学-医学:研究与实验
CiteScore
3.80
自引率
4.00%
发文量
966
审稿时长
6 months
期刊介绍: Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
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