增强认知储备在精神病遗传风险儿童、青少年和年轻人中的有效性:一项随机对照试验的研究方案

0 PSYCHIATRY
Elena de la Serna , Laura Montejo , Brisa Solé , Josefina Castro-Fornieles , Patricia Camprodon-Boadas , Gisela Sugranyes , Mireia Rosa-Justicia , Anabel Martinez-Aran , Eduard Vieta , Muriel Vicent-Gil , Maria Serra-Blasco , Narcís Cardoner , Carla Torrent
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引用次数: 7

摘要

背景双相情感障碍和精神分裂症(Off-BDSZ)患者的后代患精神疾病的遗传风险很高。该项目的目的是基于认知储备的概念,开发和调查针对这一人群的干预措施的有效性。方法本研究为多中心随机试验,采用实验重测设计,对照组。将包括两组:社区比较组(CC)和Off-BDSZ组。共招募108名Off-BDSZ和65名CC,年龄在6 - 25岁之间。Off-BDSZ参与者将随机接受认知储备增强疗法(CREATE) (n = 54)或支持疗法(n = 54)。CC组将在基线进行评估。干预的持续时间为3个月,每周进行12次小组会议。主要观察结果是根据健康认知储备量表(CRASH)和青少年认知储备量表(CORE-A)的变化来测量CR的改善。所有参与者将在基线、三个月(心理干预后)和治疗完成后12个月的随访时,使用临床、认知和神经影像学指标进行盲目评估。本研究结果将深入探讨CREATE-Offspring版本是否可以增强儿童、青少年和青年Off-BDSZ的认知储备(CR),并进一步了解与改善CR相关的临床表现、神经心理表现和大脑结构和功能的变化。这一新颖且具有成本效益的干预措施代表了心理健康预防干预框架的进步。临床试验注册:clinicaltrials .gov, NCT03722082。于2018年10月26日注册
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Effectiveness of enhancing cognitive reserve in children, adolescents and young adults at genetic risk for psychosis: Study protocol for a randomized controlled trial

Background

Offspring of patients diagnosed with bipolar disorder and schizophrenia (Off-BDSZ) have a high genetic risk of developing a mental illness. The aim of this project is to develop and investigate the efficacy of an intervention aimed at this population, based on the concept of cognitive reserve.

Methods

This is a multicenter randomized trial with an experimental test–retest design study with control group. Two groups will be included: a community comparison group (CC) and a Off-BDSZ group. A total of 108 Off-BDSZ and 65 CC aged between 6 and 25 years will be recruited. Off-BDSZ participants will be randomized to receive either Cognitive Reserve EnhAncement ThErapy (CREATE) (n = 54), or a supportive approach (n = 54). The CC group will be assessed at baseline. The duration of the intervention will be 3 months, with 12 weekly group sessions. The primary outcome will be the improvement in CR measured according to change in the Cognitive Reserve Assessment Scale in Health (CRASH) and Cognitive Reserve scale for Adolescents (CORE-A). All participants will be blindly evaluated using clinical, cognitive and neuroimaging measures at baseline, at three months (after the psychological intervention), and at twelve-month follow-up after treatment completion.

Discussion

The results will provide insight into whether the CREATE-Offspring version may enhance cognitive reserve (CR) in child, adolescent and young adult Off-BDSZ as well as advance knowledge about changes in clinical manifestations, neuropsychological performance and brain structure and function associated with improving CR. This novel and cost-effective intervention represents an advance in the framework of preventive interventions in mental health.

Trial registration

Clinicaltrials.gov, NCT03722082. Registered on 26 October 2018.

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