Computerized Cognitive Remediation Therapy in Adolescents With a First Psychotic Episode: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Long Term Visual Memory
研究概览
简要总结
Cognitive deficits (CD) are considered one of the essential characteristics in psychotic disorders and occur throughout the course of the disease, being a key characteristic in the evolution of the disease and in the functionality and prognosis of patients. Intervening in the early stages of the disease and specifically in adolescence, a period of high brain plasticity can reduce disabilities in adulthood associated with early-onset psychosis. The objective of this study is to assess the efficacy of cognitive rehabilitation therapy in adolescents with a first psychotic episode, comparing two groups of these patients: a first group (CCRT) will carry out 40 sessions of a computerized cognitive remediation therapy with the usual treatment too, and a second group will perform only the usual treatment (TAU). The main hypothesis is that the CCRT group will present a significant improvement in verbal memory, visual attention, executive function, and social cognition and will present better global functioning compared to the TAU group.
详细描述
Cognitive deficits (DC) are considered one of the essential features in psychotic disorders and occur throughout the course of the disease. Recent meta-analyses have shown that cognitive remediation therapy can reduce DCs in basic cognitive processes such as attention, memory, and problem solving and can have an impact on social functioning.
The aim of this study is to evaluate the effectiveness of a computerized cognitive remediation intervention in cognitive and functional improvement in patients with a first psychotic episode that is psychopathologically stable but presents cognitive impairment.
The hypotheses that are raised are:
-
In relation to the cognitive field. Participants in the computerized cognitive remediation therapy + treatment as usual (CCRT) group versus the participants in the treatment as usual (TAU) group are expected to improve in (evaluated by MATRICS):
-
Verbal memory
-
Visual attention
-
Executive function
-
Social cognition
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In relation to other symptoms. Participants in the CCRT group versus the participants in the TAU group are expected to:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 12-18 years
- •DSM-5 diagnostic criteria for schizophrenia or schizoaffective disorder (F20 or F25, DSM-5) beginning at age 17 or earlier;
- •Clinically and pharmacologically stabilized;
- •No changes in drug treatment for 6 weeks from baseline assessment;
- •Presence of cognitive impairment according to criteria adapted in Penades et al. and following the same criteria in previous studies with similar populations. In this sense, at least one of the following criteria must be present:
- •2 discrepant scores (a score is discrepant when the T scores are 1 DE below the patient's estimated IQ
- •Either a score T below 37 in persevering Wisconsin Card Sorting Test (WCST) errors by Heaton et al. (1981).
- •Diagnosis and diagnostic stability verified by a psychiatrist or senior psychologist or member of the research team using the DSM-5 criteria and based on clinical interviews with the patient and his family.
排除标准
- •Intellectual disability CI estimated equivalent to or <70);
- •Active substance abuse;
- •Neurological impairment;
- •Have received electro-convulsive therapy in the 6 months prior to treatment;
- •Do not sign informed consent.
研究组 & 干预措施
Computerized Cognitive Remediation Intervention and Treatment as Usual (CCRT+TAU)
Participants with a diagnosis of schizophrenia / schizoaffective disorder undergo Computerized CRT and the usual treatment.
Three evaluations are carried out, each one divided into two sessions: an evaluation before the start of treatment, a second evaluation after finishing the Computerized CRT (after 40 sessions), and a third evaluation (follow-up) 6 months after finishing the Computerized CRT.
干预措施: Computerized Cognitive Remediation Therapy (Behavioral)
Treatment as Usual (TAU)
Participants with a diagnosis of schizophrenia / schizoaffective disorder undergo the usual treatment.
Two evaluations will be carried out, also divided into two sessions: a first baseline evaluation and a second evaluation 5 months later, after receiving the usual treatment. After this second evaluation, the Computerized CRT is then started to guarantee ethics in all patients.
The evaluation is not carried out at 6 months since they will also have received the intervention.
干预措施: Treatment as Usual (Other)
Computerized Cognitive Remediation Intervention and Treatment as Usual (CCRT+TAU)
Participants with a diagnosis of schizophrenia / schizoaffective disorder undergo Computerized CRT and the usual treatment.
Three evaluations are carried out, each one divided into two sessions: an evaluation before the start of treatment, a second evaluation after finishing the Computerized CRT (after 40 sessions), and a third evaluation (follow-up) 6 months after finishing the Computerized CRT.
干预措施: Treatment as Usual (Other)
结局指标
主要结局
Long Term Visual Memory
时间窗: 1 week
T-score, long term, Rey-Osterrieth complex figure (HVLT-R; Brandt 1991)
Working memory Spatial Span
时间窗: 11 months
T-score, Spatial Span Wechsler Intelligence Scale for Adults (WAIS-IV) (Wechsler, 2012)
Executive functions, TMT-B
时间窗: 11 months
T-score, Trail Making Test: Part B (TMT; Reitan, 1971) Range: 0 (lowest) to 100 (highest)
Processing Speed FAS Word Fluency
时间窗: 11 months
T-score, FAS Word Fluency (Guilford, 1967) Range: 0 (lowest) to 100 (highest)
Long term Verbal Memory
时间窗: 11 months
T-score, long term, Hopkins Verbal Learning Test- Revised (HVLT-R; Brandt 1991)
Verbal Memory, Learning
时间窗: 11 months
T-score, learning, Hopkins Verbal Learning Test- Revised (HVLT-R; Brandt 1991)
Global Functioning
时间窗: 11 months
T-score, GAF: Global Assesment Functioning-Scale (Endicott et al, 1976) Range: 0 (lowest) to 100 (highest)
Attention
时间窗: 11 months
Confidence Index, Continuous Performance Test - II (CPT-II; Rosvold, 1956)
Working memory Letter-Number Span (WISC-V)
时间窗: 11 months
T-score: Letter-Number Span Test, Wechsler Intelligence Scale for Children-Five Edition (WISC-V) (Wechsler, 2014)
Working memory digits (WISC-V)
时间窗: 11 months
T-score, Digits Test, Wechsler Intelligence Scale for Children-Five Edition (WISC-V) (Wechsler, 2014) Range: 0 (lowest) to 100 (highest)
Working memory digits
时间窗: 11 months
T-score, Digits Test, Wechsler Intelligence Scale for Adults (WAIS-IV) (Wechsler, 2012) Range: 0 (lowest) to 100 (highest)
Social Cognition
时间窗: 11 months
Faces Test de Baron-Cohen (Wheelwright y Jolliffe,1997) Range: 0 (lowest) to 28 (highest)
Processing Speed Coding
时间窗: 11 months
T-score, Symbol Coding de la Brief Assessment of Cognition in Schizophrenia (BACS)(Keefe, 2004) Range: 0 (lowest) to 100 (highest)
Processing Speed Semantic Word Fluency
时间窗: 11 months
T-score, Semantic Word Fluency (Guilford, 1967) Range: 0 (lowest) to 100 (highest)
Working memory Spatial Span (WISC-V)
时间窗: 11 months
T-score, Spatial Span Wechsler Intelligence Scale for Children-Five Edition (WISC-V) (Wechsler, 2014)
Working memory Letter-Number Span
时间窗: 11 months
T-score: Letter-Number Span Test, Wechsler Intelligence Scale for Adults (WAIS-IV) (Wechsler, 2012)
Processing Speed TMT-A
时间窗: 11 months
T-score, Trail Making Test: Part A (TMT; Reitan, 1971) Range: 0 (lowest) to 100 (highest)
Long term Visual Memory
时间窗: 11 months
T-score, long term, Rey-Osterrieth complex figure (HVLT-R; Brandt 1991)
Organization Visual Memory
时间窗: 11 months
Percentile, organization, Rey-Osterrieth complex figure (HVLT-R; Brandt 1991)
Executive functions, categories
时间窗: 11 months
T-score, Wisconsin Card Sorting Test (WCST; Heaton et al.,1981) Range: 0 (lowest) to 100 (highest)
Global Functioning
时间窗: 1 week
T-score, GAF: Global Assesment Functioning-Scale (Endicott et al, 1976) Range: 0 (lowest) to 100 (highest)
Global Functioning
时间窗: 5 months
T-score, GAF: Global Assesment Functioning-Scale (Endicott et al, 1976) Range: 0 (lowest) to 100 (highest)
Long term Verbal Memory
时间窗: 1 week
T-score, long term, Hopkins Verbal Learning Test- Revised (HVLT-R; Brandt 1991)
Long term Verbal Memory
时间窗: 5 months
T-score, long term, Hopkins Verbal Learning Test- Revised (HVLT-R; Brandt 1991)
Verbal Memory, Learning
时间窗: 1 week
T-score, learning, Hopkins Verbal Learning Test- Revised (HVLT-R; Brandt 1991)
Verbal Memory, Learning
时间窗: 5 months
T-score, learning, Hopkins Verbal Learning Test- Revised (HVLT-R; Brandt 1991)
Attention
时间窗: 1 week
Confidence Index, Continuous Performance Test - II (CPT-II; Rosvold, 1956)
Attention
时间窗: 5 months
Confidence Index, Continuous Performance Test - II (CPT-II; Rosvold, 1956)
Long term Visual Memory
时间窗: 5 months
T-score, long term, Rey-Osterrieth complex figure (HVLT-R; Brandt 1991)
Organization Visual Memory
时间窗: 1 week
Percentile, organization, Rey-Osterrieth complex figure (HVLT-R; Brandt 1991)
Organization Visual Memory
时间窗: 5 months
Percentile, organization, Rey-Osterrieth complex figure (HVLT-R; Brandt 1991)
Working memory Spatial Span (WISC-V)
时间窗: 1 week
T-score, Spatial Span Wechsler Intelligence Scale for Children-Five Edition (WISC-V) (Wechsler, 2014)
Working memory Spatial Span
时间窗: 1 week
T-score, Spatial Span Wechsler Intelligence Scale for Adults (WAIS-IV) (Wechsler, 2012)
Working memory Spatial Span (WISC-V)
时间窗: 5 months
T-score, Spatial Span Wechsler Intelligence Scale for Children-Five Edition (WISC-V) (Wechsler, 2014)
Working memory Spatial Span
时间窗: 5 months
T-score, Spatial Span Wechsler Intelligence Scale for Adults (WAIS-IV) (Wechsler, 2012)
Working memory Letter-Number Span (WISC-V)
时间窗: 1 week
T-score: Letter-Number Span Test, Wechsler Intelligence Scale for Children-Five Edition (WISC-V) (Wechsler, 2014)
Working memory Letter-Number Span
时间窗: 1 week
T-score: Letter-Number Span Test, Wechsler Intelligence Scale for Adults (WAIS-IV) (Wechsler, 2012)
Working memory Letter-Number Span (WISC-V)
时间窗: 5 months
T-score: Letter-Number Span Test, Wechsler Intelligence Scale for Children-Five Edition (WISC-V) (Wechsler, 2014)
Working memory Letter-Number Span
时间窗: 5 months
T-score: Letter-Number Span Test, Wechsler Intelligence Scale for Adults (WAIS-IV) (Wechsler, 2012)
Working memory digits (WISC-V)
时间窗: 1 week
T-score, Digits Test, Wechsler Intelligence Scale for Children-Five Edition (WISC-V) (Wechsler, 2014)
Working memory digits
时间窗: 1 week
T-score, Digits Test, Wechsler Intelligence Scale for Adults (WAIS-IV) (Wechsler, 2012) Range: 0 (lowest) to 100 (highest)
Working memory digits (WISC-V)
时间窗: 5 months
T-score, Digits Test, Wechsler Intelligence Scale for Children-Five Edition (WISC-V) (Wechsler, 2014) Range: 0 (lowest) to 100 (highest)
Working memory digits
时间窗: 5 months
T-score, Digits Test, Wechsler Intelligence Scale for Adults (WAIS-IV) (Wechsler, 2012) Range: 0 (lowest) to 100 (highest)
Social Cognition
时间窗: 1 week
Faces Test de Baron-Cohen (Wheelwright y Jolliffe,1997) Range: 0 (lowest) to 28 (highest)
Social Cognition
时间窗: up to 5 months
Faces Test de Baron-Cohen (Wheelwright y Jolliffe,1997) Range: 0 (lowest) to 28 (highest)
Executive functions, categories
时间窗: 1 week
T-score, Wisconsin Card Sorting Test (WCST; Heaton et al.,1981) Range: 0 (lowest) to 100 (highest)
Executive functions, categories
时间窗: 5 months
T-score, Wisconsin Card Sorting Test (WCST; Heaton et al.,1981) Range: 0 (lowest) to 100 (highest)
Executive functions, TMT-B
时间窗: 1 week
T-score, Trail Making Test: Part B (TMT; Reitan, 1971) Range: 0 (lowest) to 100 (highest)
Executive functions, TMT-B
时间窗: 5 months
T-score, Trail Making Test: Part B (TMT; Reitan, 1971) Range: 0 (lowest) to 100 (highest)
Processing Speed TMT-A
时间窗: 1 week
T-score, Trail Making Test: Part A (TMT; Reitan, 1971) Range: 0 (lowest) to 100 (highest)
Processing Speed TMT-A
时间窗: 5 months
T-score, Trail Making Test: Part A (TMT; Reitan, 1971) Range: 0 (lowest) to 100 (highest)
Processing Speed Coding
时间窗: 1 week
T-score, Symbol Coding de la Brief Assessment of Cognition in Schizophrenia (BACS)(Keefe, 2004) Range: 0 (lowest) to 100 (highest)
Processing Speed Coding
时间窗: 5 months
T-score, Symbol Coding de la Brief Assessment of Cognition in Schizophrenia (BACS)(Keefe, 2004) Range: 0 (lowest) to 100 (highest)
Processing Speed FAS Word Fluency
时间窗: 1 week
T-score, FAS Word Fluency (Guilford, 1967) Range: 0 (lowest) to 100 (highest)
Processing Speed FAS Word Fluency
时间窗: 5 months
T-score, FAS Word Fluency (Guilford, 1967) Range: 0 (lowest) to 100 (highest)
Processing Speed Semantic Word Fluency
时间窗: 1 week
T-score, Semantic Word Fluency (Guilford, 1967) Range: 0 (lowest) to 100 (highest)
Processing Speed Semantic Word Fluency
时间窗: 5 months
T-score, Semantic Word Fluency (Guilford, 1967) Range: 0 (lowest) to 100 (highest)
次要结局
- Sex(1 week)
- Medical History(1 week)
- Psychopathology(1 week)
- Family Psychiatric History(1 week)
- Hospitalization(1 week)
- toxics(11 months)
- Personal Psychiatric History(1 week)
- General psychopathology(11 months)
- IQ (WISC-V)(1 week)
- Positive symptoms(11 months)
- Negative symptoms(11 months)
- IQ(1 week)
- socioeconomic status(1 week)
- Date of birth(1 week)
- Obstetric Risk(1 week)
- Development History(1 week)
- Psychiatric treatment(1 week)
- toxics(1 week)
- Positive symptoms(1 week)
- toxics(5 months)
- Positive symptoms(5 months)
- Negative symptoms(1 week)
- Negative symptoms(5 months)
- General psychopathology(1 week)
- General psychopathology(5 months)