Efficacy Study of GAÏA Program Cognitive Remediation of Facial Affects Processing in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Facial Emotions Recognition Task(TREF)
研究概览
简要总结
Social cognition impairments was highlighted for persons suffering with schizophrenia by numerous studies. The use of treatment programs intended to treat specifically these deficits through procedures of cognitive remediation, will allow decreasing their impact on everyday life by improving abilities to understand and interact with others. Such tools could allow also profits in terms of reduction of positive and negative of schizophrenia. The Gaïa program is intended to improve the perception of the facial affects which is one of social cognition processes impaired in schizophrenia.
Methods:
This is a multicenter, randomized, controlled study comparing people aged 18 to 45 years with a diagnostic of schizophrenia according to the Diagnostic and Statistical manuel of Mental disorders, 4th edition (DSM-IV-TR).
The GAÏA program will be compared to an already validated neurocognitive remediation program, training attentional processes (RECOS).
100 patients will be randomized as follows: Arm 1, experimental: Gaïa (20h with therapist, computer assisted method) Arm 2, control: RECOS (20h with therapist, computer assisted method)
Condition: Schizophrenia Intervention: Behavioural: computer assisted cognitive remediation
Hypothesis:
A targeted cognitive remediation will more increased abilities in facial affects recognition processes than a non specific, attentional cognitive remediation.
Primary outcome measures:
- Change from baseline in performances in the Facial Emotion Recognition Task (TREF) after 10 weeks and 20 session of treatment.
Secondary outcome measures
- Change from baseline in clinical, psychosocial, social cognition and neurocognitive measures, after 10 weeks and 20 session of treatment and at 6 months follow-up.
- Change from baseline in performances in the Facial Emotion Recognition Task (TREF) after treatment and 6 months follow-up.
详细描述
Purpose:
Rationale:
Social cognition impairments was highlighted for persons suffering with schizophrenia by numerous studies. The use of treatment programs intended to treat specifically these deficits through procedures of cognitive remediation, will allow decreasing their impact on everyday life by improving abilities to understand and interact with others. Such tools could allow also profits in terms of reduction of positive and negative of schizophrenia. The Gaïa program is intended to improve the perception of the facial affects which is one of social cognition processes impaired in schizophrenia.
Methods:
This is a multicenter, randomized, controlled study comparing people aged 18 to 45 years with a diagnostic of schizophrenia according to the DSM-IV-TR.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18 to 45 years
- •French speaker
- •Clinical stability
- •Diagnosis of schizophrenia according to the DSM-IV-TR
- •Agreement of the guardian for the patients under guardianship
- •Unchanged psychotropic treatment during month preceding the inclusion
- •Overdrawn performances in the treatment of the facial information
- •Patients having given their consent lit to participate in the study
排除标准
- •alcohol or drug dependence (according to the DSM-IV-TR), except tobacco
- •history of neurobiological illness or trauma
- •the ineffectiveness of neuroleptic treatment
- •Taking of medicine with somatic aim having a cerebral or psychic impact
- •Simultaneous participation on an other program of cognitive remediation
结局指标
主要结局
Facial Emotions Recognition Task(TREF)
时间窗: week 11
The TREF presents 54 photos representing 6 basic emotions (joy, anger, sadness, fear, disgust and contempt). Each emotion is presented with 9 intensity levels (from 20% to 100%),and by 4 models (2 mens and 2 womens) Subject has to select his answer in a list of 6 items (joy, anger, sadness, fear, disgust and contempt), each photo is presented during 10 seconds maximum, there's no time limit to answer.
次要结局
- Change from baseline in symptoms measure 1(week 11 and 6 month follow-up)
- Change from baseline in social cognition measures(week 11 and 6 month follow-up)
- Change from baseline in neurocognitive functioning measures(week 11and 6 month follow-up)
- Change from baseline in symptoms measure 2(week 11 and 6 month follow-up)
- TREF (Facial emotions recognition task)(6 month follow up)
- Change from baseline in insight measure(week 11 and 6 month follow-up)
- Change from baseline in self estime measure(week 11 and 6 month follow up)
- Change from baseline in social functioning measure(week 11 and 6 month follow-up)