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Efficacy of a transdiagnostic ecological momentary intervention for improving self-esteem (SELFIE) in youth exposed to childhood adversity: study protocol for a multi-center randomized controlled trial
Trials ( IF 2.0 ) Pub Date : 2021-09-19 , DOI: 10.1186/s13063-021-05585-y
Maud Daemen 1, 2 , Mary Rose Postma 1, 3 , Ramon Lindauer 4, 5 , Iris Hoes-van der Meulen 6 , Dorien Nieman 7 , Philippe Delespaul 1 , Josefien Johanna Froukje Breedvelt 7, 8 , Mark van der Gaag 9, 10 , Wolfgang Viechtbauer 1 , Koen Schruers 1, 11 , David van den Berg 9, 10 , Claudi Bockting 7, 8 , Therese van Amelsvoort 1, 3 , Ulrich Reininghaus 1, 2, 12
Affiliation  

Targeting low self-esteem in youth exposed to childhood adversity is a promising strategy for preventing adult mental disorder, but psychological help remains difficult to access and accept for youth, calling for novel, youth-friendly approaches. Mobile Health (mHealth) and, most prominently, ecological momentary interventions (EMIs) provide a unique opportunity to deliver youth-friendly, personalized, real-time, guided self-help interventions. The aim of this study is to investigate the efficacy of a novel, accessible, transdiagnostic ecological momentary intervention for improving self-esteem (‘SELFIE’) in youth with prior exposure to childhood adversity. In a parallel-group, assessor-blind, multi-center randomized controlled trial, individuals aged 12–26 years with prior exposure to childhood adversity and low self-esteem will be randomly allocated to SELFIE in addition to treatment as usual (TAU) as the experimental condition or the control condition of TAU only, which will include access to all standard health care. SELFIE is a digital guided self-help intervention administered through a smartphone-based app to allow for interactive, personalized, real-time and real-world transfer of intervention components in individuals’ daily lives, blended with three training sessions delivered by trained mental health professionals over a 6-week period. Outcomes will be assessed at baseline, post-intervention, and 6-month follow-up by blinded assessors. The primary outcome will be the level of self-esteem as measured with the Rosenberg Self-Esteem Scale (RSES). The current study is the first to establish the efficacy of an EMI focusing on improving self-esteem transdiagnostically in youth exposed to childhood adversity. If this trial provides evidence on the efficacy of SELFIE, it has significant potential to contribute to minimizing the deleterious impact of childhood adversity and, thereby, preventing the development of mental disorder later in life. Netherlands Trial Register NL7129 (NTR7475 ). Registered on 9 November 2018

中文翻译:


跨诊断生态瞬时干预对于改善童年逆境青少年自尊(SELFIE)的功效:多中心随机对照试验的研究方案



针对童年时期遭遇逆境的青少年的低自尊是预防成人精神障碍的一个有前途的策略,但青少年仍然难以获得和接受心理帮助,需要新颖的、青少年友好的方法。移动健康 (mHealth) 以及最突出的生态瞬时干预 (EMI) 提供了独特的机会来提供青少年友好的、个性化的、实时的、有指导的自助干预措施。本研究的目的是调查一种新颖的、易于使用的、跨诊断的生态瞬时干预对于改善曾经历过童年逆境的青少年的自尊(“SELFIE”)的功效。在一项平行组、评估者盲法、多中心随机对照试验中,年龄在 12-26 岁、之前曾经历过童年逆境且自卑的个体除了照常治疗 (TAU) 外,还将被随机分配到 SELFIE 组,如下所示:仅 TAU 的实验条件或对照条件,其中包括获得所有标准医疗保健。 SELFIE 是一种数字引导的自助干预,通过基于智能手机的应用程序进行管理,允许在个人日常生活中进行交互式、个性化、实时和真实的干预成分转移,并与经过培训的心理健康人员提供的三个培训课程相结合为期 6 周的专业人士。结果将由盲法评估员在基线、干预后和 6 个月随访时进行评估。主要结果是用罗森伯格自尊量表(RSES)测量的自尊水平。目前的研究首次确定了 EMI 的功效,重点是通过跨诊断的方式提高遭受童年逆境的青少年的自尊。 如果这项试验提供了自拍功效的证据,那么它就有巨大的潜力有助于最大限度地减少童年逆境的有害影响,从而预防以后生活中精神障碍的发展。荷兰试验注册 NL7129 (NTR7475)。2018年11月9日注册
更新日期:2021-09-19
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