Clinical trial NCT04040829: Cognitive Remediation and Supported Education in Psychotic Disorders
Official title: Cognitive Remediation and Supported Education in Psychotic Disorders: a Randomized Controlled Trial on the Efficacy and the Best Predictors of Academic Functioning
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Psychotic Disorders
Keywords: Cognitive remediation therapy
Supported education
Academic functioning
Schizophrenia
Cognition
Photovoice
Mixed qualitative and quantitative methodology
Lead sponsor: Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec
Sponsor class: OTHER
Collaborators: name: Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
name: Centre hospitalier de l'Université de Montréal (CHUM)
First posted: 2019-08-01
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a two arm single blind randomized trial comparing Cognitive remediation therapy + Supported education + Treatment as usual with Supported Education + Treatment as usual alone
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.)

Primary outcomes:
measure: Mean change from baseline on the First-Episode Social Functioning Scale (School subscale)
timeFrame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
measure: Mean change from baseline on the First-Episode Social Functioning Scale (School subscale)
timeFrame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
measure: Mean change from baseline on the First-Episode Social Functioning Scale (School subscale)
timeFrame: Baseline (T0; moment of enrollment in the study) to 1-year post-treatment (T3; one year following the end of the intervention)
measure: Mean change from baseline on the First-Episode Social Functioning Scale (Relationships and social activities at school subscale)
timeFrame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
measure: Mean change from baseline on the First-Episode Social Functioning Scale (Relationships and social activities at school subscale)
timeFrame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
measure: Mean change from baseline on the First-Episode Social Functioning Scale (Relationships and social activities at school subscale)
timeFrame: Baseline (T0; moment of enrollment in the study) to 1-year post-treatment (T3; one year following the end of the intervention)
measure: Mean change from baseline on the Rubric tool
timeFrame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
measure: Mean change from baseline on the Rubric tool
timeFrame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
measure: Mean change from baseline on the Rubric tool
timeFrame: Baseline (T0; moment of enrollment in the study) to 1-year post-treatment (T3; one year following the end of the intervention)
Secondary outcomes:
measure: Raw score change from baseline on the California verbal learning test-II (CVLT-II) (delayed recall).
timeFrame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
measure: Raw score change from baseline on the California verbal learning test-II (CVLT-II) (delayed recall).
timeFrame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
measure: Raw score change from baseline on the Rey Complex Figure test (delayed recall).
timeFrame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
measure: Raw score change from baseline on the Rey Complex Figure test (delayed recall).
timeFrame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
measure: Raw score change from baseline on the digit span subtest backward of the Wechsler Adult Intelligence Scale-IV (WAIS-IV)
timeFrame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
measure: Raw score change from baseline on the digit span subtest backward of the Wechsler Adult Intelligence Scale-IV (WAIS-IV)
timeFrame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
measure: Raw score change from baseline on the coding subtest of the Wechsler Adult Intelligence Scale-IV (WAIS-IV)
timeFrame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
measure: Raw score change from baseline on the coding subtest of the Wechsler Adult Intelligence Scale-IV (WAIS-IV)
timeFrame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
measure: Raw score change from baseline on the spatial span subtest backward of the Wechsler Memory Scale
timeFrame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
measure: Raw score change from baseline on the spatial span subtest backward of the Wechsler Memory Scale
timeFrame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
measure: Raw score change from baseline on the Hit Reaction Time Block Change (HRT-BC) of the Continuous Performance Test-3 (CPT-3)
timeFrame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
measure: Raw score change from baseline on the Hit Reaction Time Block Change (HRT-BC) of the Continuous Performance Test-3 (CPT-3)
timeFrame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
measure: Raw score change from baseline on the fourth condition of the Trail Making Test (Delis-Kaplan Executive Function System; D-KEFS)
timeFrame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
measure: Raw score change from baseline on the fourth condition of the Trail Making Test (Delis-Kaplan Executive Function System; D-KEFS)
timeFrame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
measure: Raw score change from baseline on the third condition of the color-word interference (Delis-Kaplan Executive Function System; D-KEFS)
timeFrame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
measure: Raw score change from baseline on the third condition of the color-word interference (Delis-Kaplan Executive Function System; D-KEFS)
timeFrame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
measure: Raw score change from baseline on the verbal fluency subtest (first condition) (Delis-Kaplan Executive Function System; D-KEFS)
timeFrame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
measure: Raw score change from baseline on the verbal fluency subtest (first condition) (Delis-Kaplan Executive Function System; D-KEFS)
timeFrame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
measure: Raw score change from baseline on the Tower of London (total item completed with the minimum movement)
timeFrame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
measure: Raw score change from baseline on the Tower of London (total item completed with the minimum movement)
timeFrame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
measure: Raw score change from baseline on the Matrix subtest of the Wechsler Adult Intelligence Scale-IV (WAIS-IV)
timeFrame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
measure: Raw score change from baseline on the Matrix subtest of the Wechsler Adult Intelligence Scale-IV (WAIS-IV)
timeFrame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
measure: Raw score change from baseline on the Combined Stories test
timeFrame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
measure: Raw score change from baseline on the Combined Stories test
timeFrame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
measure: Raw score change from baseline on the Social Knowledge test
timeFrame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
measure: Raw score change from baseline on the Social Knowledge test
timeFrame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
measure: Raw score change from baseline on the Penn Emotion Recognition task
timeFrame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
measure: Raw score change from baseline on the Penn Emotion Recognition task
timeFrame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
measure: Raw score change from baseline on the Échelle de Répercussion Fonctionnelle
timeFrame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
measure: Raw score change from baseline on the Échelle de Répercussion Fonctionnelle
timeFrame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
measure: Raw score change from baseline on the Positive And Negative Syndrome Scale (PANSS)
timeFrame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
measure: Raw score change from baseline on the Positive And Negative Syndrome Scale (PANSS)
timeFrame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
measure: Raw score change from baseline on the Self-Esteem Rating Scale (SERS)
timeFrame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
measure: Raw score change from baseline on the Self-Esteem Rating Scale (SERS)
timeFrame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
measure: Raw score change from baseline on the Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS)
timeFrame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
measure: Raw score change from baseline on the Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS)
timeFrame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
measure: Raw score change from baseline on the First-Episode Social Functioning Scale (FESFS)
timeFrame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
measure: Raw score change from baseline on the First-Episode Social Functioning Scale (FESFS)
timeFrame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
measure: Raw score change from baseline on the Childhood Trauma Questionnaire (CTQ)
timeFrame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
measure: Raw score change from baseline on the Childhood Trauma Questionnaire (CTQ)
timeFrame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
measure: Presence or absence of a genetic variant (Met66Met) of the Brain-derived neurotrophic factor (BDNF) gene (Val66Met) at baseline
timeFrame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
measure: Presence or absence of a genetic variant (Met66Met) of the Brain-derived neurotrophic factor (BDNF) gene (Val66Met) at baseline
timeFrame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
measure: Presence or absence of the Val158Met polymorphism on the Catechol-O-Methyltransferase (COMT) gene
timeFrame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
measure: Presence or absence of the Val158Met polymorphism on the Catechol-O-Methyltransferase (COMT) gene
timeFrame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre de recherche de l'Institut universitaire en santé mentale de Montréal
state: Quebec
city: Montréal
country: Canada
facility: Centre hospitalier universitaire de Montréal
state: Quebec
city: Québec
country: Canada
facility: Centre de recherche CERVO
Study officials:
affiliation: Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec
name: Caroline Cellard, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
name: Tania Lecomte, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Université du Québec a Montréal
name: Marc Corbière, Ph.D
role: PRINCIPAL_INVESTIGATOR
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