Cognitive Remediation and Supported Education in Psychotic Disorders

NCT04040829 | Terminated DMC

• 1 other identifier: MP-13-2019-1538, NSM (MP)
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 3

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.

Conditions

Psychotic Disorders

Keywords

Cognitive remediation therapy; Supported education; Academic functioning; Schizophrenia; Cognition; Photovoice; Mixed qualitative and quantitative methodology

Outcome Measures

Primary Outcomes (9)

• Mean change from baseline on the First-Episode Social Functioning Scale (School subscale)

  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.

  Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)

• Mean change from baseline on the First-Episode Social Functioning Scale (School subscale)

  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.

  Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)

• Mean change from baseline on the First-Episode Social Functioning Scale (School subscale)

  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.

  Baseline (T0; moment of enrollment in the study) to 1-year post-treatment (T3; one year following the end of the intervention)

• Mean change from baseline on the First-Episode Social Functioning Scale (Relationships and social activities at school subscale)

  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.

  Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)

• Mean change from baseline on the First-Episode Social Functioning Scale (Relationships and social activities at school subscale)

  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.

  Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)

• Mean change from baseline on the First-Episode Social Functioning Scale (Relationships and social activities at school subscale)

  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.

  Baseline (T0; moment of enrollment in the study) to 1-year post-treatment (T3; one year following the end of the intervention)

• Mean change from baseline on the Rubric tool

  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).

  Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)

• Mean change from baseline on the Rubric tool

  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).

  Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)

• Mean change from baseline on the Rubric tool

  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).

  Baseline (T0; moment of enrollment in the study) to 1-year post-treatment (T3; one year following the end of the intervention)

Secondary Outcomes (44)

• 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 Post-treatment (T1; directly after the 3-months period of intervention)

• 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 Post-treatment (T1; directly after the 3-months period of 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 Post-treatment (T1; directly after the 3-months period of intervention)

Study Arms (2)

SE + TAU

ACTIVE COMPARATOR

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.

Behavioral: Supported education (SE); Other: Treatment as usual (TAU)

CR + SE + TAU

EXPERIMENTAL

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.

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

Interventions

Cognitive remediation therapy (CR) BEHAVIORAL

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.

CR + SE + TAU

Supported education (SE) BEHAVIORAL

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.

CR + SE + TAU; SE + TAU

Treatment as usual (TAU) OTHER

Treatment as usual (TAU) consists of medication and routine contact with the clinical team.

CR + SE + TAU; SE + TAU

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec: lead
• Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal: collaborator
• Centre hospitalier de l'Université de Montréal (CHUM): collaborator

Study Sites (3)

Centre de recherche de l'Institut universitaire en santé mentale de Montréal

Montreal, Quebec, H1N 3V2, Canada

Location

Centre hospitalier universitaire de Montréal

Montreal, Quebec, H2X 3E4, Canada

Location

Centre de recherche CERVO

Québec, Quebec, G1J2G3, Canada

Location

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MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Caroline Cellard, Ph.D

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

  PRINCIPAL INVESTIGATOR

• Tania Lecomte, Ph.D

  Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal

  PRINCIPAL INVESTIGATOR

• Marc Corbière, Ph.D

  Université du Québec a Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: This study is a single blind trial assessing Cognitive remediation therapy + Supported education + Treatment as usual

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: August 1, 2019
• Study Start: September 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2023
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)