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A feasibility study will be conducted to assess the online administration of the cognitive remediation program CIRCuiTS.
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| Name | Class |
|---|---|
| Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal | OTHER |
| Centre hospitalier de l'Université de Montréal (CHUM) | OTHER |
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This trial aims to assess the added value of cognitive remediation therapy to supported education intervention in young adults with a psychotic disorder. The objectives of this study are threefold: The first objective is to evaluate the efficacy of supported education and cognitive remediation therapy for young adults with psychotic disorders in terms of academic outcome (primary outcome) and cognitive, neurobiological, and psychological outcomes (secondary outcomes). The second objective is to explore mechanisms of change in academic outcomes using a multidimensional approach (cognitive, psychological and biological characteristics) in youth with psychotic disorders. The third objective is to investigate the patients' perspectives regarding their appreciation of the supported education programs.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive remediation therapy (CR) | Behavioral | Cognitive remediation therapy is a behavioral intervention that aims to improve cognition. This intervention has the goal to produce long-term improvements in cognition as well as to generalize these improvements in daily functioning. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline on the First-Episode Social Functioning Scale (School subscale) | The FESFS assesses different aspect of functioning including social functioning, productive activities and instrumental activities of daily living. Each question is rated on a Likert scale ranging from 1=Totally disagree to 4= Completely agree. The School subscale assesses the ability to meet deadlines, punctuality and school performance. | Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention) |
| Mean change from baseline on the First-Episode Social Functioning Scale (School subscale) | The FESFS assesses different aspect of functioning including social functioning, productive activities and instrumental activities of daily living. Each question is rated on a Likert scale ranging from 1=Totally disagree to 4= Completely agree. The School subscale assesses the ability to meet deadlines, punctuality and school performance. | Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention) |
| Mean change from baseline on the First-Episode Social Functioning Scale (School subscale) | The FESFS assesses different aspect of functioning including social functioning, productive activities and instrumental activities of daily living. Each question is rated on a Likert scale ranging from 1=Totally disagree to 4= Completely agree. The School subscale assesses the ability to meet deadlines, punctuality and school performance. | Baseline (T0; moment of enrollment in the study) to 1-year post-treatment (T3; one year following the end of the intervention) |
| Mean change from baseline on the First-Episode Social Functioning Scale (Relationships and social activities at school subscale) | The FESFS assesses different aspect of functioning including social functioning, productive activities and instrumental activities of daily living. Each question is rated on a Likert scale ranging from 1=Totally disagree to 4= Completely agree. Relationships and social activities at school subscale assesses relationships with professors and students as well as participation in class. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Caroline Cellard, Ph.D | Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec | Principal Investigator |
| Tania Lecomte, Ph.D | Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal | Principal Investigator |
| Marc Corbière, Ph.D | Université du Québec a Montréal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de recherche de l'Institut universitaire en santé mentale de Montréal | Montreal | Quebec | H1N 3V2 | Canada | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22377576 | Background | 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. | |
| 11483142 | Background | 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. |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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This study is a single blind trial assessing Cognitive remediation therapy + Supported education + Treatment as usual
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Assessors will be blind to treatment allocation, but patients, cognitive remediation therapists and supported education specialists will not be blind. We will ask participants to not disclose their group allocation to the assessor. Furthermore, each patient will be assessed by a different assessor for each time point (T0, T1, T2, T3) to ensure blindness.
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| Supported education (SE) | Behavioral | Supported education (SE) is a behavioral intervention that aims to help people return to school and/or succeed in school. SE offers a wide range of services that are personalized to the needs of each patients. |
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| Treatment as usual (TAU) | Other | Treatment as usual (TAU) consists of medication and routine contact with the clinical team. |
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| Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention) |
| Mean change from baseline on the First-Episode Social Functioning Scale (Relationships and social activities at school subscale) | The FESFS assesses different aspect of functioning including social functioning, productive activities and instrumental activities of daily living. Each question is rated on a Likert scale ranging from 1=Totally disagree to 4= Completely agree. Relationships and social activities at school subscale assesses relationships with professors and students as well as participation in class. | Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention) |
| Mean change from baseline on the First-Episode Social Functioning Scale (Relationships and social activities at school subscale) | The FESFS assesses different aspect of functioning including social functioning, productive activities and instrumental activities of daily living. Each question is rated on a Likert scale ranging from 1=Totally disagree to 4= Completely agree. Relationships and social activities at school subscale assesses relationships with professors and students as well as participation in class. | Baseline (T0; moment of enrollment in the study) to 1-year post-treatment (T3; one year following the end of the intervention) |
| Mean change from baseline on the Rubric tool | The Rubric tool assesses six domains of academic functioning, namely contributions, attitude, preparedness, focus on the task, professionalism and effort, and a composite score from those six scales. Based on the rating of several questions, a mean score of each domain, as well as a total score, will be obtained using a Likert scale that ranges from 1 (lowest the student can achieve) to 4 (highest the student can achieve). | Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention) |
| Mean change from baseline on the Rubric tool | The Rubric tool assesses six domains of academic functioning, namely contributions, attitude, preparedness, focus on the task, professionalism and effort, and a composite score from those six scales. Based on the rating of several questions, a mean score of each domain, as well as a total score, will be obtained using a Likert scale that ranges from 1 (lowest the student can achieve) to 4 (highest the student can achieve). | Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention) |
| Mean change from baseline on the Rubric tool | The Rubric tool assesses six domains of academic functioning, namely contributions, attitude, preparedness, focus on the task, professionalism and effort, and a composite score from those six scales. Based on the rating of several questions, a mean score of each domain, as well as a total score, will be obtained using a Likert scale that ranges from 1 (lowest the student can achieve) to 4 (highest the student can achieve). | Baseline (T0; moment of enrollment in the study) to 1-year post-treatment (T3; one year following the end of the intervention) |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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. | 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. | 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 | 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 | 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 | 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 | 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). | 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). | 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 | 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 | Baseline (T0; moment of enrollment in the study) to 3-months post-treatment (T2; three months following the end of the intervention) |
| Centre hospitalier universitaire de Montréal |
| Montreal |
| Quebec |
| H2X 3E4 |
| Canada |
| Centre de recherche CERVO | Québec | Quebec | G1J2G3 | Canada |
| 22295007 | Background | 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. |
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