Transdiagnostic Markers of Cognitive Symptoms in Disorders Affective.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Cognitive outcome
研究概览
简要总结
The objective of this project is to determine the concordance between the subjective and objective evaluation of cognitive functions in affective patients in partial remission through scales and cognitive tests that would be easily implemented in the different mental health care devices.
This is a cross-sectional case-control study of non-probabilistic sampling, which will include a group of patients diagnosed with Major Depressive Disorder and Bipolar Disorder and a group of healthy controls from the same population and matched by age, gender and years of education with the group of patients.
Patients will be recruited from the psychiatric service of the Hospital de la Santa Creu i Sant Pau who meet the inclusion criteria, and they will undergo a blood draw, a clinical assessment, a complete neuropsychological examination together with scales of subjective perception of cognitive deficit, a measure of cognitive reserve and an evaluation of psychosocial functionality. In addition, the same evaluation will be made to a group of healthy subjects.The total sample will be 120
详细描述
This is a cross-sectional study with the following hypotheses and objectives:
- Patients will show an objective cognitive deficit with both subjective and objective measures compared to healthy controls.
- Subjectively and objectively assessed cognitive deficits will show moderate agreement in patients with a depressive episode in partial remission, as each assesses different aspects of cognition.
- Both the subjective and the objective assessment will have a high agreement between patients with DM and TB, demonstrating the transdiagnostic nature of self-assessed and heteroassessed cognitive deficits.
- Cognitive Reserve will be a mediating factor in the correlation between subjective and objective cognitive evaluation.
- BDNF and GSH will be associated with the patients' cognitive deficit and will act as mediators between the subjective and objective assessment.
Main Objective:
To study the impact of cognitive reserve and trophic factors and oxidative stress as transdiagnostic markers of cognitive symptoms (subjective and objective) in patients with DM and TB.
- Cognitively assess patients with DM and TB (in a depressive episode) through subjective assessment and objective assessment.
- Evaluate the possible implementation of objective (SCIP) and subjective (COBRA, PDQ) cognitive assessment instruments.
- Determine the degree of agreement between both types of cognitive assessment both intra-patient and inter-diagnostic.
- Determine the factors associated with the degree of agreement between both assessments (Cognitive Reserve, BDNF and GSH) in and between both affective disorders.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •8 and 60 years (males and females)
- •diagnosis of Major Depression (criteria Diagnostic and Statistical Manual 5th edition, DSM-5) in Remission or Partial Remission phase (scores below 14 in the Hamilton Depression Rating Scale-17 items (HDRS-17))
- •Cognitive Symptoms (-1.5SD (standar deviation) in objective as subjective tests)
- •PDQ > 20
- •FAST> 17
排除标准
- •Intelligence Quotient (IQ) < 85
- •Any medical condition that may affect cognition
- •Presence of any comorbid psychiatric condition (including abuse or dependence on substances in the last three months)
- •Electroconvulsive therapy (ECT) in the previous year
- •Other psychological intervention in the 6 months prior to the study.
结局指标
主要结局
Cognitive outcome
时间窗: 1 assessment
Composite score of different neuropsychological tests
次要结局
未报告次要终点
研究者
Maria J Portella
Head of the Research Group in Psychiatric Disorders, Hospital de Sant Pau
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau