Cognitive Remediation and Supported Education in Psychotic Disorders (REUSSIR)

Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec

Status: Suspended

Conditions: Psychotic Disorders

Treatments: Other: Treatment as usual (TAU); Behavioral: Cognitive remediation therapy (CR); Behavioral: Supported education (SE)

Study type: Interventional

Funder types: Other

Identifiers

NCT04040829

MP-13-2019-1538, NSM (MP)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 16 to 35 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

SE + TAU

Active Comparator group

Description:

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.

Treatment:

Behavioral: Supported education (SE)

Other: Treatment as usual (TAU)

CR + SE + TAU

Experimental group

Description:

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.

Treatment:

Behavioral: Supported education (SE)

Behavioral: Cognitive remediation therapy (CR)

Other: Treatment as usual (TAU)