Cognitive Remediation and Supported Education in Psychotic Disorders
NCT ID: NCT04040829
Last Updated: 2021-02-01
Study Results
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Basic Information
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SUSPENDED
NA
80 participants
INTERVENTIONAL
2021-09-01
2024-09-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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SE + TAU
Supported education (SE) includes a variety of services ranging from orientation, study strategies or homework help. This intervention is personalized to the need of each patient in terms of services and frequency. Previous to this randomized controlled trial, we conducted interviews with each site that will provide SE. In these interviews, we explored the fidelity of their services to the Individual Placement and Support adapted to education. Information regarding the dosage of SE (frequency, length of session, type of support) will be collected and used as covariates for each participant since intensity treatment can impact outcomes.
Treatment as usual (TAU) consists of medication and routine contact with the clinical team. Patients will continue to receive their standard treatment, but we will collect information regarding the type of medication, the dosage, and all other relevant information and use it as covariate in our analyses.
Supported education (SE)
Supported education (SE) is a behavioral intervention that aims to help people return to school and/or succeed in school. SE offers a wide range of services that are personalized to the needs of each patients.
Treatment as usual (TAU)
Treatment as usual (TAU) consists of medication and routine contact with the clinical team.
CR + SE + TAU
Cognitive remediation therapy (CR) will be conducted using CIRCuiTS, a computerized program designed to improve cognition (attention, memory, executive functioning) and metacognitive skills. CIRCuiTS has an integrated focus on the transfer of cognitive skills to daily living, using real-world goals and homework to facilitate in vivo use of new strategies, as well as a formulation-based approach, which takes into account the impact of cognitive strengths and difficulties with daily living skills. Each session includes about 4-8 tasks targeting a range of cognitive problems, which become more ecologically valid as the program progresses. The rate of delivery for CIRCuiTS will be two to three sessions per week, for a maximum of 40 sessions. The therapy will be provided entirely online with a therapist, using the platform Zoom.
This arm will include our active control condition : supported education (SE) as well as Treatment as usual (TAU) as previously described.
Cognitive remediation therapy (CR)
Cognitive remediation therapy is a behavioral intervention that aims to improve cognition. This intervention has the goal to produce long-term improvements in cognition as well as to generalize these improvements in daily functioning.
Supported education (SE)
Supported education (SE) is a behavioral intervention that aims to help people return to school and/or succeed in school. SE offers a wide range of services that are personalized to the needs of each patients.
Treatment as usual (TAU)
Treatment as usual (TAU) consists of medication and routine contact with the clinical team.
Interventions
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Cognitive remediation therapy (CR)
Cognitive remediation therapy is a behavioral intervention that aims to improve cognition. This intervention has the goal to produce long-term improvements in cognition as well as to generalize these improvements in daily functioning.
Supported education (SE)
Supported education (SE) is a behavioral intervention that aims to help people return to school and/or succeed in school. SE offers a wide range of services that are personalized to the needs of each patients.
Treatment as usual (TAU)
Treatment as usual (TAU) consists of medication and routine contact with the clinical team.
Eligibility Criteria
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Inclusion Criteria
* 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
* plans to change medication during the study
* receiving concurrently another type of therapy (e.g. Cognitive Behavioral Therapy (CBT), etc.)
16 Years
35 Years
ALL
No
Sponsors
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Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
OTHER
Centre hospitalier de l'Université de Montréal (CHUM)
OTHER
Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec
OTHER
Responsible Party
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Caroline Cellard
Associate professor
Principal Investigators
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Caroline Cellard, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec
Tania Lecomte, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
Marc Corbière, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Université du Québec a Montréal
Locations
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Centre de recherche de l'Institut universitaire en santé mentale de Montréal
Montreal, Quebec, Canada
Centre hospitalier universitaire de Montréal
Montreal, Quebec, Canada
Centre de recherche CERVO
Québec, , Canada
Countries
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References
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Other Identifiers
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MP-13-2019-1538, NSM (MP)
Identifier Type: -
Identifier Source: org_study_id
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