Cognitive Remediation and Supported Education in Psychotic Disorders: a Randomized Controlled Trial on the Efficacy and the Best Predictors of Academic Functioning

Brief Summary

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.

Primary Outcomes

Secondary Outcomes

• 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))