Psychotic DisordersREUSSIRNCT04040829

Cognitive Remediation and Supported Education in Psychotic Disorders

A study testing Cognitive remediation therapy (CR), Supported education (SE) and Treatment as usual (TAU) in people with Psychotic Disorders, run by Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec at 3 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 16 to 35 years
Conditions the study is for: Psychotic Disorders
What is being tested?: Cognitive remediation therapy (CR), Supported education (SE) and Treatment as usual (TAU)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 3 sitesCanada
Study dates: 1 Sep 2021to 30 Jun 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 to 35 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

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 locations and contacts

3 sites in 1 country.

Canada3 sites

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

Other trials in Canada

About this study

Official title: 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.

Read the 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.

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: Psychotic Disorders
Being tested: Cognitive remediation therapy (CR), Supported education (SE), Treatment as usual (TAU)
Keywords: Cognitive remediation therapy, Supported education, Academic functioning, Schizophrenia, Cognition, Photovoice, Mixed qualitative and quantitative methodology
Medical subject headings: Psychotic Disorders, Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cognitive remediation therapy (CR)Behavioural
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)Behavioural
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)Other
Treatment as usual (TAU) consists of medication and routine contact with the clinical team.

Study groups in NCT04040829
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Cognitive remediation therapy (CR); Behavioral: Supported education (SE); Other: Treatment as usual (TAU)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
The coding subtest assesses speed of processing. The participant has to match as many numbers as possible with symbols based on a key.
Measured: 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)
The coding subtest assesses speed of processing. The participant has to match as many numbers as possible with symbols based on a key.
Measured: 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
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.
Measured: 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
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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
Measured: 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)
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
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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)
The PANSS is a semi-structured interview that assess clinical symptoms of psychotic disorder, including positive symptoms, negative symptoms and general psychopathology.
Measured: 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)
The PANSS is a semi-structured interview that assess clinical symptoms of psychotic disorder, including positive symptoms, negative symptoms and general psychopathology.
Measured: 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)
The SERS assesses self-esteem. The questionnaire includes 20 questions rated on a Likert scale from 1=Never to 7=Always
Measured: 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)
The SERS assesses self-esteem. The questionnaire includes 20 questions rated on a Likert scale from 1=Never to 7=Always
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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
Measured: 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)
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
Measured: 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)
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
Measured: 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)
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
Measured: 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
Presence or absence of a genetic variant (Met66Met) of the BDNF gene (Val66Met).
Measured: 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
Presence or absence of a genetic variant (Met66Met) of the BDNF gene (Val66Met).
Measured: 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
Single nucleotide polymorphisms (SNP) in the 3' end of the COMT gene and the Val158Met polymorphism
Measured: 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
Single nucleotide polymorphisms (SNP) in the 3' end of the COMT gene and the Val158Met polymorphism
Measured: Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 202130 Jun 2023

First posted1 Aug 2019
Study start1 Sep 2021
Primary completion30 Jun 2022
Study completion30 Jun 2023

Why it stopped: A feasibility study will be conducted to assess the online administration of the cognitive remediation program CIRCuiTS.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (46)Papers the sponsor has linked to this study.
Other trials for Psychotic DisordersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Model description: This study is a single blind trial assessing Cognitive remediation therapy + Supported education + Treatment as usual
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04040829
Sponsor's protocol ID: MP-13-2019-1538, NSM (MP)
Acronym: REUSSIR
Status last verified: Mar 2026
First submitted: 29 Jul 2019
Last updated: 19 Mar 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Achim AM, Ouellet R, Roy MA, Jackson PL. Mentalizing in first-episode psychosis. Psychiatry Res. 2012 Apr 30;196(2-3):207-13. doi: 10.1016/j.psychres.2011.10.011. Epub 2012 Feb 28.
PubMed 22377576
Bell M, Bryson G, Greig T, Corcoran C, Wexler BE. Neurocognitive enhancement therapy with work therapy: effects on neuropsychological test performance. Arch Gen Psychiatry. 2001 Aug;58(8):763-8. doi: 10.1001/archpsyc.58.8.763.
PubMed 11483142
Bond GR, Drake RE, Becker DR. Generalizability of the Individual Placement and Support (IPS) model of supported employment outside the US. World Psychiatry. 2012 Feb;11(1):32-9. doi: 10.1016/j.wpsyc.2012.01.005.
PubMed 22295007
Bosia M, Bechi M, Marino E, Anselmetti S, Poletti S, Cocchi F, Smeraldi E, Cavallaro R. Influence of catechol-O-methyltransferase Val158Met polymorphism on neuropsychological and functional outcomes of classical rehabilitation and cognitive remediation in schizophrenia. Neurosci Lett. 2007 May 7;417(3):271-4. doi: 10.1016/j.neulet.2007.02.076. Epub 2007 Mar 2.
PubMed 17383818
Bosia M, Zanoletti A, Spangaro M, Buonocore M, Bechi M, Cocchi F, Pirovano A, Lorenzi C, Bramanti P, Smeraldi E, Cavallaro R. Factors affecting cognitive remediation response in schizophrenia: the role of COMT gene and antipsychotic treatment. Psychiatry Res. 2014 Jun 30;217(1-2):9-14. doi: 10.1016/j.psychres.2014.02.015. Epub 2014 Feb 19.
PubMed 24656901
Carmona VR, Gomez-Benito J, Huedo-Medina TB, Rojo JE. Employment outcomes for people with schizophrenia spectrum disorder: A meta-analysis of randomized controlled trials. Int J Occup Med Environ Health. 2017 May 8;30(3):345-366. doi: 10.13075/ijomeh.1896.01074. Epub 2017 Apr 26.
PubMed 28481370
Cellard C, Reeder C, Paradis-Giroux AA, Roy MA, Gilbert E, Ivers H, Bouchard RH, Maziade M, Wykes T. A feasibility study of a new computerised cognitive remediation for young adults with schizophrenia. Neuropsychol Rehabil. 2016;26(3):321-44. doi: 10.1080/09602011.2015.1019891. Epub 2015 Mar 10.
PubMed 25753694
Corbiere M, Bond GR, Goldner EM, Ptasinski T. Brief reports: the fidelity of supported employment implementation in Canada and the United States. Psychiatr Serv. 2005 Nov;56(11):1444-7. doi: 10.1176/appi.ps.56.11.1444.
PubMed 16282266
Cutler DM, Lleras-Muney A. Education and health: evaluating theories and evidence (No. w12352). National bureau of economic research, 2006
Davidson L. Living outside mental illness: qualitative studies of recovery in schizophrenia, University Press, New York, 2003
Day JC, Newburger EC. The Big Payoff: Educational Attainment and Synthetic Estimates of Work-Life Earnings. Special Studies. Current Population Reports, 2002
Delis DC, Kramer J, Kaplan E, Ober, B. CVLT-II. San Antonio, TX: The Psychological Corporation, 2000
Diaz-Asper CM, Goldberg TE, Kolachana BS, Straub RE, Egan MF, Weinberger DR. Genetic variation in catechol-O-methyltransferase: effects on working memory in schizophrenic patients, their siblings, and healthy controls. Biol Psychiatry. 2008 Jan 1;63(1):72-9. doi: 10.1016/j.biopsych.2007.03.031. Epub 2007 Aug 20.
PubMed 17707347
Fett AK, Viechtbauer W, Dominguez MD, Penn DL, van Os J, Krabbendam L. The relationship between neurocognition and social cognition with functional outcomes in schizophrenia: a meta-analysis. Neurosci Biobehav Rev. 2011 Jan;35(3):573-88. doi: 10.1016/j.neubiorev.2010.07.001. Epub 2010 Jul 8.
PubMed 20620163
Fisher M, Mellon SH, Wolkowitz O, Vinogradov S. Neuroscience-informed Auditory Training in Schizophrenia: A Final Report of the Effects on Cognition and Serum Brain-Derived Neurotrophic Factor. Schizophr Res Cogn. 2016 Mar 1;3:1-7. doi: 10.1016/j.scog.2015.10.006.
PubMed 26705516

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Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cognitive Remediation and Supported Education in Psychotic Disorders: a Randomized Controlled Trial on the Efficacy and the Best Predictors of Academic Functioning
ClinicalTrials.gov ID: NCT04040829
Acronym / sponsor ID: REUSSIR / MP-13-2019-1538, NSM (MP)
Conditions: Psychotic Disorders
Keywords: Cognitive remediation therapy, Supported education, Academic functioning, Schizophrenia, Cognition, Photovoice, Mixed qualitative and quantitative methodology
Study type: Interventional
Recruitment status: TerminatedReason stopped: A feasibility study will be conducted to assess the online administration of the cognitive remediation program CIRCuiTS.
Enrolment: 9 participants (actual)
Lead sponsor: Centre de Recherche de l'Institut Universitaire en Santé Mentale de QuébecUniversity, hospital or other
Collaborators: Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal, Centre hospitalier de l'Université de Montréal (CHUM)
Study start: 1 Sep 2021 (actual)
Primary completion: 30 Jun 2022 (actual)
Study completion: 30 Jun 2023 (actual)
First posted: 1 Aug 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2
Model description: This study is a single blind trial assessing Cognitive remediation therapy + Supported education + Treatment as usual

Arm	Type	Receives
SE + TAU	Active comparator	Behavioral: Supported education (SE), Other: Treatment as usual (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.
CR + SE + TAU	Experimental	Behavioral: Cognitive remediation therapy (CR), Behavioral: Supported education (SE), Other: Treatment as usual (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.

Who may qualify

Ages: 16 to 35 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

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.)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Behavioural	CR + SE + TAU
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.	Behavioural	CR + SE + TAU, SE + TAU
Treatment as usual (TAU)Treatment as usual (TAU) consists of medication and routine contact with the clinical team.	Other	CR + SE + TAU, SE + TAU

Primary outcome

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.
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.
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.
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.
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.
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.
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).
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).
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).

44 secondary outcomes

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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)

Results and safety

The study was stopped early (reason given: A feasibility study will be conducted to assess the online administration of the cognitive remediation program CIRCuiTS.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
Background: PubMed 22377576Achim AM, Ouellet R, Roy MA, Jackson PL. Mentalizing in first-episode psychosis. Psychiatry Res. 2012 Apr 30;196(2-3):207-13. doi: 10.1016/j.psychres.2011.10.011. Epub 2012 Feb 28.
Background: PubMed 11483142Bell M, Bryson G, Greig T, Corcoran C, Wexler BE. Neurocognitive enhancement therapy with work therapy: effects on neuropsychological test performance. Arch Gen Psychiatry. 2001 Aug;58(8):763-8. doi: 10.1001/archpsyc.58.8.763.
Background: PubMed 22295007Bond GR, Drake RE, Becker DR. Generalizability of the Individual Placement and Support (IPS) model of supported employment outside the US. World Psychiatry. 2012 Feb;11(1):32-9. doi: 10.1016/j.wpsyc.2012.01.005.
Background: PubMed 17383818Bosia M, Bechi M, Marino E, Anselmetti S, Poletti S, Cocchi F, Smeraldi E, Cavallaro R. Influence of catechol-O-methyltransferase Val158Met polymorphism on neuropsychological and functional outcomes of classical rehabilitation and cognitive remediation in schizophrenia. Neurosci Lett. 2007 May 7;417(3):271-4. doi: 10.1016/j.neulet.2007.02.076. Epub 2007 Mar 2.
Background: PubMed 24656901Bosia M, Zanoletti A, Spangaro M, Buonocore M, Bechi M, Cocchi F, Pirovano A, Lorenzi C, Bramanti P, Smeraldi E, Cavallaro R. Factors affecting cognitive remediation response in schizophrenia: the role of COMT gene and antipsychotic treatment. Psychiatry Res. 2014 Jun 30;217(1-2):9-14. doi: 10.1016/j.psychres.2014.02.015. Epub 2014 Feb 19.
Background: PubMed 28481370Carmona VR, Gomez-Benito J, Huedo-Medina TB, Rojo JE. Employment outcomes for people with schizophrenia spectrum disorder: A meta-analysis of randomized controlled trials. Int J Occup Med Environ Health. 2017 May 8;30(3):345-366. doi: 10.13075/ijomeh.1896.01074. Epub 2017 Apr 26.
Background: PubMed 25753694Cellard C, Reeder C, Paradis-Giroux AA, Roy MA, Gilbert E, Ivers H, Bouchard RH, Maziade M, Wykes T. A feasibility study of a new computerised cognitive remediation for young adults with schizophrenia. Neuropsychol Rehabil. 2016;26(3):321-44. doi: 10.1080/09602011.2015.1019891. Epub 2015 Mar 10.
Background: PubMed 16282266Corbiere M, Bond GR, Goldner EM, Ptasinski T. Brief reports: the fidelity of supported employment implementation in Canada and the United States. Psychiatr Serv. 2005 Nov;56(11):1444-7. doi: 10.1176/appi.ps.56.11.1444.
BackgroundCutler DM, Lleras-Muney A. Education and health: evaluating theories and evidence (No. w12352). National bureau of economic research, 2006
BackgroundDavidson L. Living outside mental illness: qualitative studies of recovery in schizophrenia, University Press, New York, 2003
BackgroundDay JC, Newburger EC. The Big Payoff: Educational Attainment and Synthetic Estimates of Work-Life Earnings. Special Studies. Current Population Reports, 2002
BackgroundDelis DC, Kramer J, Kaplan E, Ober, B. CVLT-II. San Antonio, TX: The Psychological Corporation, 2000
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Caroline Cellard, Ph.D principal investigator

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

Tania Lecomte, Ph.D principal investigator

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

Marc Corbière, Ph.D principal investigator

Université du Québec a Montréal

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04040829, which also lists 46 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.