Cognitive Rehabilitation in Patients With Active and Remitted Depression - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Behavior Rating Inventory of Executive Function (BRIEF: self and informant form)
研究概览
简要总结
Depression is a highly prevalent and debilitating mental disorder, ranked one of the leading causes of disability worldwide. Several studies have identified neuropsychological deficits in populations of depressed patients affecting domains including attention, memory and executive functioning. These deficits often persist even in patients whose depressive symptoms have remitted. Cognitive impairment in depression represent a core feature of depression, and a valuable target for intervention. Identification of methods that would lead to amelioration would be of great clinical interest, and cognitive rehabilitation (CR) could be a potential way of achieving this. To date few studies on cognitive rehabilitation in depression has been conducted, but the preliminary results are promising. Still the demonstration of long-term effects and evidence relating to improved daily life executive functioning (i.e., generalization) is lacking. In the present study different group-based cognitive rehabilitation interventions will be compared. The aim of the study is to investigate if a group-based "brain training" intervention can improve executive function in patients with active and remitted depression. Efficacy will be assessed immediately after intervention, but also six months after the intervention.
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed treatment for mild or moderate MDD
- •Evidence of executive dysfunction in everyday life determined by (a) a structured interview or (b) a self-report Behavior Rating Inventory of Executive Function (BRIEF) T-score < 55.
排除标准
- •Cognitive, sensory, physical, or language impairment affecting the capacity to complete the training program.
- •Premorbid neurological disease or insult and/or comorbid neurological disorder.
- •Reported ongoing alcohol or substance abuse.
- •Psychotic disorders.
- •Actively suicidal.
- •Personality disorder sever enough to interfere with the protocol.
- •Not fluent in Norwegian language.
研究组 & 干预措施
Goal Management Training
干预措施: Goal Management Training (Behavioral)
Computerized Cognitive Training
干预措施: Computerized Cognitive Training (Behavioral)
结局指标
主要结局
Behavior Rating Inventory of Executive Function (BRIEF: self and informant form)
时间窗: Change from baseline up to 6 months
Executive function in daily life (range:70-210). Higher score indicate greater executive dysfunction.
次要结局
- Performance on D-KEFS Color Word Interference Test(change from baseline up to 6 months)
- Score on Goal Attainment Scaling (GAS)(change from baseline up to 6 months)
- Performance on Conners Continuous Performance test III incl. CATA(change from baseline up to 6 months)
- Performance on Wisconsin Card Sorting Test(change from baseline up to 6 months)
- Performance on The Emotional Stroop(change from baseline up to 6 months)
- Performance on the Emo 1-back task(change from baseline up to 6 months)
- Score on Cognitive Failures Questionnaire (CFQ)(change from baseline up to 6 months)
- Score on Beck Depression Inventory II (BDI-II)(change from baseline up to 6 months)
- Score on Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM)(change from baseline up to 6 months)
- Score on General Perceived Self-Efficacy Scale(change from baseline up to 6 months)
- Score on Return to Work Self-Efficacy Scale (RTW-SE)(change from baseline up to 6 months)
- Score on Difficulties in Emotion Regulation Scale (DERS)(change from baseline up to 6 months)
- Score on The Ruminative Response Scale (RRS)(change from baseline up to 6 months)