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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 2.5 ) 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

针对暴露于童年逆境的青少年的低自尊是预防成人精神障碍的一种很有前景的策略,但青少年仍然难以获得和接受心理帮助,因此需要新颖的、对青少年友好的方法。移动健康 (mHealth) 以及最突出的生态瞬时干预 (EMI) 提供了一个独特的机会,可以提供对青年友好的、个性化的、实时的、有指导的自助干预。本研究的目的是调查一种新颖的、可访问的、跨诊断的生态瞬时干预对改善曾经历过童年逆境的青年的自尊 ('SELFIE') 的功效。在平行组、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和低自尊的个体将被随机分配到 SELFIE 以及作为实验条件的照常治疗 (TAU) 或仅作为 TAU 的控制条件,这将包括访问所有标准的医疗保健。SELFIE 是一种数字引导自助干预,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交互、个性化、实时和真实地转移干预成分,并结合由受过训练的心理健康人员提供的三个培训课程专业人士超过 6 周。结果将由不知情的评估人员在基线、干预后和 6 个月的随访中进行评估。主要结果将是用罗森伯格自尊量表 (RSES) 衡量的自尊水平。目前的研究首次确定了 EMI 的功效,该研究侧重于通过诊断方法提高暴露于童年逆境的青年的自尊。如果该试验提供了关于 SELFIE 疗效的证据,则它具有极大的潜力,有助于最大程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 荷兰试验注册 NL7129 (NTR7475)。2018 年 11 月 9 日注册 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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