Study About the Effectiveness of Enhancing Cognitive Reserve in Children, Adolescents and Young Adults at Genetic Risk for Psychosis
试验速览
- 阶段
- 不适用
- 入组人数
- 173
- 试验地点
- 1
- 主要终点
- Cognitive reserve
研究概览
简要总结
The high hereditary component and the contribution of neurodevelopmental processes in bipolar disorder and schizophrenia means implies the children of these patients are considered a high risk population for both diseases and therefore a very adequate sample for the study of vulnerability markers to both disorders. To date there is no previous literature on the psychological approach of children and adolescents of bipolar or schizophrenic patients. The concept of cognitive reserve (CR) was initially developed in the field of dementia, it assumes that people with the same brain damage may have different clinical manifestations depending on their ability to compensate for this damage, so a greater cognitive reserve will entail a greater capacity to compensate the alterations and difficulties due to the pathology. Enhancing CR in high genetic risk population could help the acquisition of skills that help compensate the clinical, cognitive and neuroimaging alterations and ultimately help in the prevention of the development of pathologies for those with higher risk.This study aims to develop and apply a psychological program in order to enhance cognitive reserve (CR) in child, adolescent and young adults offspring of patients diagnosed with schizophrenia or bipolar disorder (SZBP-OFF).
详细描述
The project will have two main objectives: to test the effectiveness of the psychological program and to test if the observed improvements are stable over time (nine months of follow-up). A sample of 108 SZBP-OFF and 52 community controls will be included. Both groups will be assessed with clinical scales, neuropsychological, CR and neuroimaging assessments at baseline. Then, the SZBP-OFF group will be randomized to psychological program to enhance CR (N= 54) or to support treatment (N=54). SZBP-OFF subjects will be evaluated with clinical, CR, neuropsychological and neuroimaging tests after the psychological intervention and at nine months follow-up in order to assess if the obtained results are stable over time. The investigators hypothesize that SZBP-OFF will show lower CR scores and higher percentages of psychopathology, cognitive difficulties and brain abnormalities. The investigators also hypothesize that SZBP-OFF who received the psychological intervention will increase their CR and will decrease the severity of the observed difficulties (in clinical, neuropsychological, CR and neuroimaging areas). These results will be stable in the nine month follow-up assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Primary outcome
入排标准
- 年龄范围
- 6 Years 至 25 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Mental retardation with impaired functioning and presence of neurological disorder or history of traumatic brain injury with loss of consciousness.
结局指标
主要结局
Cognitive reserve
时间窗: 3 months afther the intervention and 12 months after baseline
Changes in cognitive reserve assessed with a specific scale which assesses the most common proposed proxy indicators such as education-occupation' which is assessed taking into account the number of years of obligatory education that subjects completed and parent's educational level; and the lifetime school performance and lifetime participation in leisure, social and physical activities.
次要结局
- Bipolar Prodrome Symptom Interview and Scale_Prospective (BPSS_FP)(12 months after baseline)
- Wisconsin Card Sorting Test(After the intervention (3 months) and 12 months after baseline)
- Hamilton Depression Rating Scale (HDRS-21)(After the intervention (3 months) and 1 year after baseline)
- Young Mania Rating Scale (YMRS)(After the intervention (3 months) and 1 year after baseline)
- Neuroimage variables(After the intervention (3 months))
- Continuous Performance Test(After the intervention (3 months) and 12 months after baseline)
- Stroop Test(After the intervention (3 months) and 12 months after baseline)
研究者
Carla Torrent
Principal Investigator
Hospital Clinic of Barcelona
