NCT07014683已完成不适用
INtegral Cognitive REMediation for Depression (INCREM). Multicentric Randomized Clinical Trial to Investigate Feasibility and Efficacy (Phase II)
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau2 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2021年9月19日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Functioning Assessment Short Test (FAST)
研究概览
简要总结
The goal of this clinical trial is to learn if INCREM intervention can improve psychosocial functioning in patients with remitted major depressive disorder. The main question it aims to answer are:
Does INCREM improve psychosocial functioning compared to psychoeducation? Does the benefits of INCREM remain after six months of the intervention compared to psychoeducation?
Researchers will compare two arms: INCREM; psychoeducation to see if psychosocial functioning improves.
Participants will be allocated to:
- INCREM
- Psychoeducation
- TAU.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-60 y.o. and beyond with a remitted or active episode of major depression (DSM-5 criteria; maximum score of 18-20 on the HDRS-17) showing cognitive symptoms (scores below 80 on the SCIP) with functional difficulties (scores above 12 on the FAST).
排除标准
- •IQ below 85;
- •any unstable or inadequately-treated medical condition that may affect neuropsychological performance;
- •being under drug treatment in the last 4 weeks with glucocorticoids, probiotics, non-steroidal anti-inflammatory drugs, bile acid sequestrants, immunosuppressive drugs, anti-histamines, mast cell stabilizers, and antioxidant supplements;
- •use of systemic antibiotics the last 2 months;
- •presence of any comorbid psychiatric condition, other than personality disorders or nicotine use disorders, in the last three months;
- •accomplish criteria for severe treatment resistant depression;
- •patients who had received electroconvulsive therapy in the previous year;
- •patients receiving any other structured psychological intervention in the 3 months prior to the study;
- •not having the necessary electronic means (computer or tablet) or internet connection to be able to participate.
结局指标
主要结局
Functioning Assessment Short Test (FAST)
时间窗: From enrollment to the end of treatment (12 weeks) and to the end of follow-up (6 months)
The FAST is a valid, widely used instrument to test psychosocial functioning. The main outcome measure will be the percentage of change in FAST scores between T0 and T1 and T2.
次要结局
- Hamilton Depression Rating Scale-17 items (HDRS_17)(From enrollment to the end of treatment (12 weeks) and to the end of follow-up (6 months))
- Screening for Cognitive Impairment in Psychiatry (SCIP)(From enrollment to the end of the intervention (12 weeks) and to the end of the follow-up (6 months))
- Perceived Deficits Questionnaire for Depression (PDQ-R)(From enrollment to the end of the intervention (12 weeks) and to the end of follow-up (6 months))
研究者
研究点 (2)
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