RIDEM Integral Remediation for Major Depression. Efficacy Study of a Functional Remediation Program and Cognitive Training
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Change from baseline Functioning Assessment Short Test (FAST) score at 6 and 15 months
研究概览
简要总结
Available pharmacological and psychotherapeutic treatments are not effective for the treatment of cognitive symptoms of major depressive disorder (MDD). More recent studies have described that functional disability and the indirect costs of MDD (e.g., sick leaves at work, decreased productivity, ...) are related to persistent cognitive deficits. Some programs of cognitive rehabilitation and cognitive training (developed for other pathologies) have been tested, but the results are inconsistent.
There is an imperative need to develop a specific comprehensive rehabilitation program for MDD that includes the benefits of traditional functional remediation (FR) and computerized cognitive training (CCT) programs adjusted for each patient's cognitive deficit.
详细描述
Objectives: To develop the Integral Rehabilitation Program (FR + CCT) and to demonstrate its efficacy in cognitive and functional remission (i.e. global remission) of patients with MDD in clinical remission.
Methodology: The project will consist of two stages:
-
- Development and adaptation of the Integral Rehabilitation program for MD, based on the program developed for bipolar disorder, and including a computerized cognitive training adjusted to the neuropsychological profile of each patient;
-
- A clinical trial, randomized, blind evaluator, with three intervention arms: INTEGRAL REHABILITATION (FR + CCT); PSYCHOEDUCATION + online games; and TREATMENT AS USUAL.
Sample size will be a total of 90 patients with MDD in remission (full or partial).
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)
盲法说明
Codification of participants, assessor will never know what treatment arm participant was allocated
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
- •18 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
Change from baseline Functioning Assessment Short Test (FAST) score at 6 and 15 months
时间窗: 3 and 12 months after intervention
Assessment of daily functioning of depressed patients, including economics, cognition, social relationships, leisure and personal care
次要结局
- Change from baseline perceived cognitive deficits (PDQ)(3 and 12 months after intervention)
研究者
Maria J Portella
Head of the Research Group in Psychiatric Disorders
Hospital de Sant Pau