Cognitive Remediation and Supported Education in Psychotic Disorders: a Randomized Controlled Trial on the Efficacy and the Best Predictors of Academic Functioning
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 80
- 试验地点
- 6
- 主要终点
- Mean change from baseline on the First-Episode Social Functioning Scale (School subscale)
研究概览
简要总结
This trial aims to assess the added value of cognitive remediation therapy to supported education intervention in young adults with a psychotic disorder. The objectives of this study are threefold: The first objective is to evaluate the efficacy of supported education and cognitive remediation therapy for young adults with psychotic disorders in terms of academic outcome (primary outcome) and cognitive, neurobiological, and psychological outcomes (secondary outcomes). The second objective is to explore mechanisms of change in academic outcomes using a multidimensional approach (cognitive, psychological and biological characteristics) in youth with psychotic disorders. The third objective is to investigate the patients' perspectives regarding their appreciation of the supported education programs.
Academic outcomes, cognitive performance as well as psychological and genetic variables will collected at baseline (T0). Participants will then be randomized either to the experimental condition (Cognitive remediation + Supported education + Treatment as usual) or the control condition (Supported education + Treatment as usual) for three months. Directly after the end of treatment (T1) and three months following the end of treatment (T2), the same measures as baseline will be repeated. One year post-treatment (T3), a last assessment will be conducted for academic outcomes.To assess qualitative experience of patients enrolled in supported education, a subsample of the randomized controlled trial will be recruited to participate in a photovoice activity.
详细描述
Psychotic disorders often occur during late adolescence and early adulthood. Cognitive deficits are among the most debilitating features of these disorders and have important impacts on academic functioning. Youth with psychotic disorders are more likely drop-out or to struggle completing high school and entering postsecondary education. Supported education programs (SE) help people with mental illness succeed in school by providing various services. However, these programs do not target cognitive deficits. Cognitive remediation therapy (CR) is an evidence-based cost-effective treatment to improve cognitive deficits. CR leads to significant improvements in cognition, symptoms and functioning, and improvements are even larger when combined with psychiatric rehabilitation interventions, such as supported employment. However, little attention has been paid to SE. Combining CR and SE is an integrative approach that could have a positive effect on academic functioning in youth with psychotic disorders.
This trial aims to assess the added value of cognitive remediation therapy to supported education intervention in young adults with a psychotic disorder. The objectives of this study are threefold: The first objective is to evaluate the efficacy of supported education and cognitive remediation therapy for young adults with psychotic disorders in terms of academic outcome (primary outcome) and cognitive, neurobiological, and psychological outcomes (secondary outcomes). The second objective is to explore mechanisms of change in academic outcomes using a multidimensional approach (cognitive, psychological and biological characteristics) in youth with psychotic disorders. The third objective is to investigate the patients' perspectives regarding their appreciation of the supported education programs.
Participants will be assessed at baseline (T0) using a multidimensional approach including academic outcomes as well as cognitive, psychological and genetic measures. Participants will then be randomized to the experimental condition (Cognitive remediation + Supported education + Treatment as usual) or the control condition (Supported education + Treatment as usual) for three months. The cognitive remediation program that will be used is CIRCuiTS (Computerised Interactive Remediation of Cognition Training for Schizophrenia). Directly after the end of treatment (T1) and three months following the end of treatment (T2), the same measures as baseline will be repeated. One year post-treatment (T3), a last assessment will be conducted for academic outcomes.
To assess qualitative experience of patients enrolled in supported education, a subsample of the randomized controlled trial will be recruited to participate in a photovoice activity. Photovoice is a participatory research approach that enables vulnerable people to act as co-researchers by identifying and representing their personal experience through photography or video. This approach notably includes a life-book approach in which participants will document their experience through photos they will take and other images they can find on the web or any other media, which will be paired with a narrative interview focusing on documenting their significant experiences going through 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
- Single (Outcomes Assessor)
盲法说明
Assessors will be blind to treatment allocation, but patients, cognitive remediation therapists and supported education specialists will not be blind. We will ask participants to not disclose their group allocation to the assessor. Furthermore, each patient will be assessed by a different assessor for each time point (T0, T1, T2, T3) to ensure blindness.
入排标准
- 年龄范围
- 16 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged from 16 to 35 years
- •diagnosis of a psychotic disorder as confirmed by a psychiatrist
- •currently enrolled or in the process of enrollment in a supported education program
- •performance more than one standard deviation below the normative mean of the participant age and sex normative group in one of the following cognitive functions: episodic memory, working memory, attention, speed of processing or executive function
排除标准
- •evidence of an organic cause of cognitive difficulties
- •plans to change medication during the study
- •receiving concurrently another type of therapy (e.g. Cognitive Behavioral Therapy (CBT), etc.)
结局指标
主要结局
Mean change from baseline on the First-Episode Social Functioning Scale (School subscale)
时间窗: Baseline (T0; moment of enrollment in the study) to 1-year post-treatment (T3; one year following the end of the intervention)
The FESFS assesses different aspect of functioning including social functioning, productive activities and instrumental activities of daily living. Each question is rated on a Likert scale ranging from 1=Totally disagree to 4= Completely agree. The School subscale assesses the ability to meet deadlines, punctuality and school performance.
Mean change from baseline on the First-Episode Social Functioning Scale (Relationships and social activities at school subscale)
时间窗: Baseline (T0; moment of enrollment in the study) to 1-year post-treatment (T3; one year following the end of the intervention)
The FESFS assesses different aspect of functioning including social functioning, productive activities and instrumental activities of daily living. Each question is rated on a Likert scale ranging from 1=Totally disagree to 4= Completely agree. Relationships and social activities at school subscale assesses relationships with professors and students as well as participation in class.
Mean change from baseline on the Rubric tool
时间窗: Baseline (T0; moment of enrollment in the study) to 1-year post-treatment (T3; one year following the end of the intervention)
The Rubric tool assesses six domains of academic functioning, namely contributions, attitude, preparedness, focus on the task, professionalism and effort, and a composite score from those six scales. Based on the rating of several questions, a mean score of each domain, as well as a total score, will be obtained using a Likert scale that ranges from 1 (lowest the student can achieve) to 4 (highest the student can achieve).
次要结局
- Raw score change from baseline on the California verbal learning test-II (CVLT-II) (delayed recall).(Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention))
- Raw score change from baseline on the Rey Complex Figure test (delayed recall).(Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention))
- Raw score change from baseline on the digit span subtest backward of the Wechsler Adult Intelligence Scale-IV (WAIS-IV)(Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention))
- Raw score change from baseline on the coding subtest of the Wechsler Adult Intelligence Scale-IV (WAIS-IV)(Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention))
- Raw score change from baseline on the spatial span subtest backward of the Wechsler Memory Scale(Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention))
- Raw score change from baseline on the Hit Reaction Time Block Change (HRT-BC) of the Continuous Performance Test-3 (CPT-3)(Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention))
- Raw score change from baseline on the fourth condition of the Trail Making Test (Delis-Kaplan Executive Function System; D-KEFS)(Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention))
- Raw score change from baseline on the third condition of the color-word interference (Delis-Kaplan Executive Function System; D-KEFS)(Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention))
- Raw score change from baseline on the verbal fluency subtest (first condition) (Delis-Kaplan Executive Function System; D-KEFS)(Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention))
- Raw score change from baseline on the Tower of London (total item completed with the minimum movement)(Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention))
- Raw score change from baseline on the Matrix subtest of the Wechsler Adult Intelligence Scale-IV (WAIS-IV)(Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention))
- Raw score change from baseline on the Combined Stories test(Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention))
- Raw score change from baseline on the Social Knowledge test(Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention))
- Raw score change from baseline on the Penn Emotion Recognition task(Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention))
- Raw score change from baseline on the Échelle de Répercussion Fonctionnelle(Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention))
- Raw score change from baseline on the Positive And Negative Syndrome Scale (PANSS)(Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention))
- Raw score change from baseline on the Self-Esteem Rating Scale (SERS)(Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention))
- Raw score change from baseline on the Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS)(Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention))
- Raw score change from baseline on the First-Episode Social Functioning Scale (FESFS)(Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention))
- Raw score change from baseline on the Childhood Trauma Questionnaire (CTQ)(Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention))
- Presence or absence of a genetic variant (Met66Met) of the Brain-derived neurotrophic factor (BDNF) gene (Val66Met) at baseline(Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention))
- Presence or absence of the Val158Met polymorphism on the Catechol-O-Methyltransferase (COMT) gene(Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention))
研究者
Caroline Cellard
Associate professor
Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec