增强有精神分裂症遗传风险的儿童、青少年和年轻成人认知储备的效果：一项随机对照试验的研究方案。

Effectiveness of enhancing cognitive reserve in children, adolescents and young adults at genetic risk for psychosis: Study protocol for a randomized controlled trial.

机构信息

Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Spain; Department of Child and Adolescent Psychiatry and Psychology, Hospital Clinic of Barcelona 2017SGR881, Institut Clinic de Neurociències, IDIBAPS, CIBERSAM, University of Barcelona, Barcelona, Spain.

Centro de Investigación Biomédica en Red de Salud Mental (CIBERSAM), Spain; Barcelona Bipolar and Depressive Unit, Hospital Clinic of Barcelona, Institute of Neurosciences, University of Barcelona, IDIBAPS, Barcelona, Spain.

出版信息

Span J Psychiatry Ment Health. 2023 Jul-Sep;16(3):184-191. doi: 10.1016/j.rpsm.2021.02.003. Epub 2021 Feb 22.

DOI:10.1016/j.rpsm.2021.02.003

PMID:33631372

Abstract

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.

摘要

背景

患有双相情感障碍和精神分裂症的患者的后代（Off-BDSZ）有很高的遗传风险患上精神疾病。本项目的目的是基于认知储备的概念，开发并研究一种针对这一人群的干预措施的效果。

方法

这是一项多中心随机试验，采用实验性测试-再测试设计，设有对照组。将包括两组：社区对照组（CC）和 Off-BDSZ 组。共招募 108 名 Off-BDSZ 和 65 名 CC，年龄在 6 至 25 岁之间。Off-BDSZ 参与者将随机分为接受认知储备增强治疗（CREATE）（n=54）或支持性方法（n=54）。CC 组将在基线时进行评估。干预的持续时间为 3 个月，每周进行 12 次小组会议。主要结果是根据认知储备评估量表在健康中的变化（CRASH）和青少年认知储备量表（CORE-A）来衡量认知储备的改善。所有参与者将在基线、三个月（心理干预后）和治疗完成后 12 个月的随访时进行盲法评估，使用临床、认知和神经影像学措施。