Cognitive Remediation and Supported Education in Psychotic Disorders

Psychotic Disorders Clinical Trial

— REUSSIR  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04040829
• Other study ID #: MP-13-2019-1538, NSM (MP)
• Status: Suspended
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: September 2024

Study information

• Verified date: January 2021
• Source: Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial aims to assess the added value of cognitive remediation therapy to supported education intervention in young adults with a psychotic disorder. The objectives of this study are threefold: The first objective is to evaluate the efficacy of supported education and cognitive remediation therapy for young adults with psychotic disorders in terms of academic outcome (primary outcome) and cognitive, neurobiological, and psychological outcomes (secondary outcomes). The second objective is to explore mechanisms of change in academic outcomes using a multidimensional approach (cognitive, psychological and biological characteristics) in youth with psychotic disorders. The third objective is to investigate the patients' perspectives regarding their appreciation of the supported education programs.

Academic outcomes, cognitive performance as well as psychological and genetic variables will collected at baseline (T0). Participants will then be randomized either to the experimental condition (Cognitive remediation + Supported education + Treatment as usual) or the control condition (Supported education + Treatment as usual) for three months. Directly after the end of treatment (T1) and three months following the end of treatment (T2), the same measures as baseline will be repeated. One year post-treatment (T3), a last assessment will be conducted for academic outcomes.To assess qualitative experience of patients enrolled in supported education, a subsample of the randomized controlled trial will be recruited to participate in a photovoice activity.

Description:

Psychotic disorders often occur during late adolescence and early adulthood. Cognitive deficits are among the most debilitating features of these disorders and have important impacts on academic functioning. Youth with psychotic disorders are more likely drop-out or to struggle completing high school and entering postsecondary education. Supported education programs (SE) help people with mental illness succeed in school by providing various services. However, these programs do not target cognitive deficits. Cognitive remediation therapy (CR) is an evidence-based cost-effective treatment to improve cognitive deficits. CR leads to significant improvements in cognition, symptoms and functioning, and improvements are even larger when combined with psychiatric rehabilitation interventions, such as supported employment. However, little attention has been paid to SE. Combining CR and SE is an integrative approach that could have a positive effect on academic functioning in youth with psychotic disorders.

This trial aims to assess the added value of cognitive remediation therapy to supported education intervention in young adults with a psychotic disorder. The objectives of this study are threefold: The first objective is to evaluate the efficacy of supported education and cognitive remediation therapy for young adults with psychotic disorders in terms of academic outcome (primary outcome) and cognitive, neurobiological, and psychological outcomes (secondary outcomes). The second objective is to explore mechanisms of change in academic outcomes using a multidimensional approach (cognitive, psychological and biological characteristics) in youth with psychotic disorders. The third objective is to investigate the patients' perspectives regarding their appreciation of the supported education programs.

Participants will be assessed at baseline (T0) using a multidimensional approach including academic outcomes as well as cognitive, psychological and genetic measures. Participants will then be randomized to the experimental condition (Cognitive remediation + Supported education + Treatment as usual) or the control condition (Supported education + Treatment as usual) for three months. The cognitive remediation program that will be used is CIRCuiTS (Computerised Interactive Remediation of Cognition Training for Schizophrenia). Directly after the end of treatment (T1) and three months following the end of treatment (T2), the same measures as baseline will be repeated. One year post-treatment (T3), a last assessment will be conducted for academic outcomes.

To assess qualitative experience of patients enrolled in supported education, a subsample of the randomized controlled trial will be recruited to participate in a photovoice activity. Photovoice is a participatory research approach that enables vulnerable people to act as co-researchers by identifying and representing their personal experience through photography or video. This approach notably includes a life-book approach in which participants will document their experience through photos they will take and other images they can find on the web or any other media, which will be paired with a narrative interview focusing on documenting their significant experiences going through the intervention.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 80
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 35 Years

Eligibility

Inclusion Criteria:

• aged from 16 to 35 years

• diagnosis of a psychotic disorder as confirmed by a psychiatrist

• currently enrolled or in the process of enrollment in a supported education program

• performance more than one standard deviation below the normative mean of the participant age and sex normative group in one of the following cognitive functions: episodic memory, working memory, attention, speed of processing or executive function

Exclusion Criteria:

• evidence of an organic cause of cognitive difficulties

• plans to change medication during the study

• receiving concurrently another type of therapy (e.g. Cognitive Behavioral Therapy (CBT), etc.)

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders

Intervention

Behavioral:
• Cognitive remediation therapy (CR)
Cognitive remediation therapy is a behavioral intervention that aims to improve cognition. This intervention has the goal to produce long-term improvements in cognition as well as to generalize these improvements in daily functioning.
• Supported education (SE)
Supported education (SE) is a behavioral intervention that aims to help people return to school and/or succeed in school. SE offers a wide range of services that are personalized to the needs of each patients.

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

Locations

Country	Name	City	State
Canada	Centre de recherche de l'Institut universitaire en santé mentale de Montréal	Montréal	Quebec
Canada	Centre hospitalier universitaire de Montréal	Montréal	Quebec
Canada	Centre de recherche CERVO	Québec

Sponsors (3)

Lead Sponsor	Collaborator
Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec	Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal, Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

References & Publications (46)

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* Note: There are 46 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	Mean change from baseline on the First-Episode Social Functioning Scale (Relationships and social activities at school subscale)	The FESFS assesses different aspect of functioning including social functioning, productive activities and instrumental activities of daily living. Each question is rated on a Likert scale ranging from 1=Totally disagree to 4= Completely agree. Relationships and social activities at school subscale assesses relationships with professors and students as well as participation in class.	Baseline (T0; moment of enrollment in the study) to Post-treatment (T1; directly after the 3-months period of intervention)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	Mean change from baseline on the Rubric tool	The Rubric tool assesses six domains of academic functioning, namely contributions, attitude, preparedness, focus on the task, professionalism and effort, and a composite score from those six scales. Based on the rating of several questions, a mean score of each domain, as well as a total score, will be obtained using a Likert scale that ranges from 1 (lowest the student can achieve) to 4 (highest the student can achieve).	Baseline (T0; moment of enrollment in the study) to 1-year post-treatment (T3; one year following the end of the intervention)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)