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.
Span J Psychiatry Ment Health. 2023 Jul-Sep;16(3):184-191. doi: 10.1016/j.rpsm.2021.02.003. Epub 2021 Feb 22.
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.
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.
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.
Clinicaltrials.gov, NCT03722082. Registered on 26 October 2018.
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。
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。
研究结果将提供有关 CREATE-Offspring 版本是否可以增强儿童、青少年和年轻 Off-BDSZ 的认知储备（CR）以及有关与改善 CR 相关的临床表现、神经心理表现、大脑结构和功能变化的知识。这种新颖且具有成本效益的干预措施代表了精神卫生预防干预框架的进步。
Clinicaltrials.gov，NCT03722082。于 2018 年 10 月 26 日注册。
