Cognitive Remediation and Supported Education in Psychotic Disorders (REUSSIR)

March 17, 2026 updated by: Caroline Cellard, Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1N 3V2
        • Centre de recherche de l'Institut universitaire en santé mentale de Montréal
      • Montreal, Quebec, Canada, H2X 3E4
        • Centre hospitalier universitaire de Montréal
      • Québec, Quebec, Canada, G1J2G3
        • Centre de recherche CERVO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Behavioral: 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.
Other: Treatment as usual (TAU)
Treatment as usual (TAU) consists of medication and routine contact with the clinical team.
Experimental: 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.
Behavioral: 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.
Other: Treatment as usual (TAU)
Treatment as usual (TAU) consists of medication and routine contact with the clinical team.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean change from baseline on the First-Episode Social Functioning Scale (School subscale)
Time Frame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
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)
Time Frame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
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)
Time Frame: Baseline (T0; moment of enrollment in the study) to 1-year post-treatment (T3; one year following the end of the intervention)
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)
Time Frame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
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)
Time Frame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
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)
Time Frame: Baseline (T0; moment of enrollment in the study) to 1-year post-treatment (T3; one year following the end of the intervention)
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
Time Frame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
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
Time Frame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
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
Time Frame: Baseline (T0; moment of enrollment in the study) to 1-year post-treatment (T3; one year following the end of the intervention)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Raw score change from baseline on the California verbal learning test-II (CVLT-II) (delayed recall).
Time Frame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
The CVLT-II assesses verbal episodic memory. The test includes the learning of a list of words, followed by an immediate and a 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).
Time Frame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
The CVLT-II assesses verbal episodic memory. The test includes the learning of a list of words, followed by an immediate and a 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).
Time Frame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
The Rey complex figure test assesses visual episodic memory. The test includes the copy of a complex figure, followed by an immediate and a 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).
Time Frame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
The Rey complex figure test assesses visual episodic memory. The test includes the copy of a complex figure, followed by an immediate and a 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)
Time Frame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
The digit span subtest backward assesses verbal working memory. A series of number are read to the participant. The participant has to recall the numbers backward.
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 digit span subtest backward of the Wechsler Adult Intelligence Scale-IV (WAIS-IV)
Time Frame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
The digit span subtest backward assesses verbal working memory. A series of number are read to the participant. The participant has to recall the numbers backward.
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)
Time Frame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
The coding subtest assesses speed of processing. The participant has to match as many numbers as possible with symbols based on a key.
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 coding subtest of the Wechsler Adult Intelligence Scale-IV (WAIS-IV)
Time Frame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
The coding subtest assesses speed of processing. The participant has to match as many numbers as possible with symbols based on a key.
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
Time Frame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
The spatial span subtest backward assesses visual working memory. A board with blocks are presented to the participant. The assessor point series of blocks and the participant has to point the blocks backward.
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 spatial span subtest backward of the Wechsler Memory Scale
Time Frame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
The spatial span subtest backward assesses visual working memory. A board with blocks are presented to the participant. The assessor point series of blocks and the participant has to point the blocks backward.
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)
Time Frame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
The HRT-BC assesses sustained attention. Letters appear on a computer screen and the participant has to press the space bar as fast as possible, except when the letter is an "X". The HRT-BC reflects the reaction time between the six conditions of the CPT-3. In each condition, the letters are presented at a different rate. A higher HRT-BC score indicates a decrease of efficiency in information processing, which suggest difficulties in sustained attention.
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 Hit Reaction Time Block Change (HRT-BC) of the Continuous Performance Test-3 (CPT-3)
Time Frame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
The HRT-BC assesses sustained attention. Letters appear on a computer screen and the participant has to press the space bar as fast as possible, except when the letter is an "X". The HRT-BC reflects the reaction time between the six conditions of the CPT-3. In each condition, the letters are presented at a different rate. A higher HRT-BC score indicates a decrease of efficiency in information processing, which suggest difficulties in sustained attention.
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)
Time Frame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
The fourth condition of the Trail Making Test assesses cognitive flexibility. Letters and numbers are presented on a page.The participants has to connect these letters in alphabetical order and the numbers in numerical order while alternating between the numbers and letters
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 fourth condition of the Trail Making Test (Delis-Kaplan Executive Function System; D-KEFS)
Time Frame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
The fourth condition of the Trail Making Test assesses cognitive flexibility. Letters and numbers are presented on a page.The participants has to connect these letters in alphabetical order and the numbers in numerical order while alternating between the numbers and letters
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)
Time Frame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
The third condition of the color-word interference assesses inhibition. Name of color written in a different color of ink are presented to the participant. The participant has to name the color of the ink for each word as fast as possible.
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 third condition of the color-word interference (Delis-Kaplan Executive Function System; D-KEFS)
Time Frame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
The third condition of the color-word interference assesses inhibition. Name of color written in a different color of ink are presented to the participant. The participant has to name the color of the ink for each word as fast as possible.
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)
Time Frame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
The first condition of the verbal fluency subtest assesses phonemic fluency. The participant has to name as many word as possible in one minute that start by a given letter.
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 verbal fluency subtest (first condition) (Delis-Kaplan Executive Function System; D-KEFS)
Time Frame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
The first condition of the verbal fluency subtest assesses phonemic fluency. The participant has to name as many word as possible in one minute that start by a given letter.
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)
Time Frame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
The Tower of London assesses planning and organization. For this test, the assessor produces different models on his board using three beads (green, blue and red). The participant has to replicate the model using as few moves as possible.
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 Tower of London (total item completed with the minimum movement)
Time Frame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
The Tower of London assesses planning and organization. For this test, the assessor produces different models on his board using three beads (green, blue and red). The participant has to replicate the model using as few moves as possible.
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)
Time Frame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
The Matrix reasoning subtest assesses perceptual reasoning. Series of complex patterns are presented to the participant. The participant has to choose the logical end to each pattern.
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 Matrix subtest of the Wechsler Adult Intelligence Scale-IV (WAIS-IV)
Time Frame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
The Matrix reasoning subtest assesses perceptual reasoning. Series of complex patterns are presented to the participant. The participant has to choose the logical end to each pattern.
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
Time Frame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
The Combined stories test assesses theory of mind. Short stories are presented to the participant and questions regarding the mental states of the characters are asked.
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 Combined Stories test
Time Frame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
The Combined stories test assesses theory of mind. Short stories are presented to the participant and questions regarding the mental states of the characters are asked.
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
Time Frame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
The Social Knowledge test assess social perception. Situations of daily life are presented to the participant. The participant is asked to state the emotion that would be felt by most people in that situation.
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 Social Knowledge test
Time Frame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
The Social Knowledge test assess social perception. Situations of daily life are presented to the participant. The participant is asked to state the emotion that would be felt by most people in that situation.
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
Time Frame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
The Penn Emotion Recognition task assesses emotion recognition. Faces expressing emotions are presented on a computer screen. The participant has to determine the emotion expressed by the character among the seven choices.
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 Penn Emotion Recognition task
Time Frame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
The Penn Emotion Recognition task assesses emotion recognition. Faces expressing emotions are presented on a computer screen. The participant has to determine the emotion expressed by the character among the seven choices.
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
Time Frame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
The Échelle de Répercussion Fonctionnelle assesses functional impact of cognitive deficits in daily living using a semi-structured interview. The severity of the functional impact is rated on a Likert scale from 1= no impact to 7=important impact.
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 Échelle de Répercussion Fonctionnelle
Time Frame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
The Échelle de Répercussion Fonctionnelle assesses functional impact of cognitive deficits in daily living using a semi-structured interview. The severity of the functional impact is rated on a Likert scale from 1= no impact to 7=important impact.
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)
Time Frame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
The PANSS is a semi-structured interview that assess clinical symptoms of psychotic disorder, including positive symptoms, negative symptoms and general psychopathology.
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 Positive And Negative Syndrome Scale (PANSS)
Time Frame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
The PANSS is a semi-structured interview that assess clinical symptoms of psychotic disorder, including positive symptoms, negative symptoms and general psychopathology.
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)
Time Frame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
The SERS assesses self-esteem. The questionnaire includes 20 questions rated on a Likert scale from 1=Never to 7=Always
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 Self-Esteem Rating Scale (SERS)
Time Frame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
The SERS assesses self-esteem. The questionnaire includes 20 questions rated on a Likert scale from 1=Never to 7=Always
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)
Time Frame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
The SSTICS assesses metacognitive knowledge, i.e., participant' perceptions of his cognitive abilities. The questionnaire includes 21 questions rated on a Likert scale ranging from 0=Never to 4=very often.
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 Subjective Scale to Investigate Cognition in Schizophrenia (SSTICS)
Time Frame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
The SSTICS assesses metacognitive knowledge, i.e., participant' perceptions of his cognitive abilities. The questionnaire includes 21 questions rated on a Likert scale ranging from 0=Never to 4=very often.
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)
Time Frame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
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
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 First-Episode Social Functioning Scale (FESFS)
Time Frame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
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
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)
Time Frame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
The CTQ assesses adverse events experienced during childhood and adolescence. The CTQ includes 70 items rated on a Likert scale ranging from 1=Never true to 5=very often true
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 Childhood Trauma Questionnaire (CTQ)
Time Frame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
The CTQ assesses adverse events experienced during childhood and adolescence. The CTQ includes 70 items rated on a Likert scale ranging from 1=Never true to 5=very often true
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
Time Frame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
Presence or absence of a genetic variant (Met66Met) of the BDNF gene (Val66Met).
Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
Presence or absence of a genetic variant (Met66Met) of the Brain-derived neurotrophic factor (BDNF) gene (Val66Met) at baseline
Time Frame: 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 BDNF gene (Val66Met).
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
Time Frame: Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
Single nucleotide polymorphisms (SNP) in the 3' end of the COMT gene and the Val158Met polymorphism
Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
Presence or absence of the Val158Met polymorphism on the Catechol-O-Methyltransferase (COMT) gene
Time Frame: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)
Single nucleotide polymorphisms (SNP) in the 3' end of the COMT gene and the Val158Met polymorphism
Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centre hospitalier de l'Université de Montréal (CHUM)
Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: 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 à Montréal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MP-13-2019-1538, NSM (MP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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