Effectiveness of a Cognitive Remediation Intervention Based on Virtual Reality for Promotion of Cognitive Functioning and Participation in Daily Life Among Persons With Affective Disorder
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 主要终点
- Adults Subjective Assessment of Participation
研究概览
简要总结
The purpose of this study is to test the efficacy of remedial cognitive intervention using The Functional Brain Trainer VR (FBT, Intendo ©) to improve cognitive functioning, participation in daily life occupations, and functional capacity in the field of IADL among people with affective disorders receiving inpatient and daycare mental-health services.
详细描述
This study is an experimental study, in a pre-post design with a control group, the sampling is convenience. The study will include 40 people aged 18-60 with a diagnosis of Affective disorder based on DSM-5.
Inclusion criteria: age 18-60, Diagnosis of Major Depression or Bipolar disorder based on DSM-5; Mood stabilizing medication for at least 2 weeks, Exclusion criteria: Neurological disorders and neurodevelopmental conditions in addition to mental health diagnosis; Physical disability in addition to mental health conditions; Psychotic state; active substance abuse; custodian.
They will be recruited from active inpatient and daycare wards of the "Geha Mental Health Center", Israel and will be randomly allocated into two groups: experimental and control. An experimental group will attend 6 VR based cognitive remediation sessions of 30 minutes for training response inhibition, self-initiation, cognitive flexibility, sustained attention, divided attention, working memory, planning, persistence. The control group will complete 6 sessions of 30 minutes of low-tech (paper and pencil tasks) remedial training of the same cognitive components. These in addition to routine care. The evaluation for symptoms severity, cognition, functional capacity and participation in daily life activities will be conducted at the beginning of the study and after about 4 weeks.
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 (Participant)
盲法说明
single
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
- •Age 18-60,
- •Diagnosis of Major Depression or Bipolar disorder based on DSM-5;
- •Mood stabilizing medication for at least 2 weeks,
排除标准
- •Neurological disorders and neuro-developmental conditions in addition to mental health diagnosis;
- •Physical disability in addition to mental health conditions;
- •Psychotic state;
- •active substance abuse;
- •custodian
结局指标
主要结局
Adults Subjective Assessment of Participation
时间窗: 3 weeks
Questionnaire for assessment of participation in daily life activities: number of participated activities (from 1 to 52, the higher number indicates higher number of participated activities) and frequency of the participation (range from 1 indicates low frequency of participation up to 7 - higher frequency of the participation)
The Observed Tasks of Daily Living - Revised
时间窗: 3 weeks
Assessment of Functional capacity, score range 1 (dependent in the performance of daily life activities) up to 26 (fully independent in the performance of the daily life activities)
次要结局
- Category Fluency Test(3 weeks)
- Hamilton Depression Rating Scale Questionnaire(3 weeks)
- Trail Making Test A & B(3 weeks)
- The Neurobehavioral Cognitive Status Examination(3 weeks)