Back to resultsEffectiveness of the Individualized Metacognitive Training (EMC+) in People With Psychosis of Brief Evolution
Primary Purpose
Brief Psychotic Disorder, Psychosis; Episode
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MCT+
Sponsored by
About this trial
This is an interventional treatment trial for Brief Psychotic Disorder
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of : schizophrenia, schizoaffective disorder, brief psychotic disorder, delusional disorder, schizophreniform disorder, psychotic disorder not otherwise specified.
- Less than 5 years of evolution.
- Score at or above 4 on the PANSS during the last year (delusions, grandiosity, suspiciousness).
Exclusion Criteria:
- Traumatic brain injury, dementia, or intellectual disability (premorbid IQ ≤70).
- Substance dependence.
- Score at or above 5 on the PANSS ( Hostility and Uncooperativeness); score at or above 6 on the PANSS (suspiciousness).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Metacognitive Training (MCT+)
TAU
Arm Description
MCT+ combines the process-oriented approach of metacognitive group training with elements of individual cognitive-behavioral therapy. The metacognitive training program is comprised of 10 modules targeting common cognitive errors in schizophrenia. (Moritz et al, 2013). The modules are: 1:Therapeutic alliance, 2: Introducyion to MCT+, 3:Disease model, 4: Attributional style, 5: Decision making, 6: Changing beliefs, 7: Empathizing, 8: Memory, 9: Depression and self-steem, 10: Relapse prevention. The treatment consist of 10 weekly sessions of 45-60 minutes.
Treatment as usual.
Outcomes
Primary Outcome Measures
PANSS. Positive and Negative Syndrome Scale. (Kay et al., 1987; Peralta and Cuesta, 1994)
The Positive and Negative Syndrome Scale (PANSS). This scale measures 30 symptoms on a scale of 1-7, with higher scores indicating greater psychopathology. The PANSS contains three sub-scales: positive, negative and general symptoms. Range: 7-112. Higher values represent a worse outcome.
PANSS. Positive and Negative Syndrome Scale. (Kay et al., 1987; Peralta and Cuesta, 1994)
The Positive and Negative Syndrome Scale (PANSS). This scale measures 30 symptoms on a scale of 1-7, with higher scores indicating greater psychopathology. The PANSS contains three sub-scales: positive, negative and general symptoms.Range: 7-112. Higher values represent a worse outcome.
PANSS. Positive and Negative Syndrome Scale. (Kay et al., 1987; Peralta and Cuesta, 1994)
The Positive and Negative Syndrome Scale (PANSS). This scale measures 30 symptoms on a scale of 1-7, with higher scores indicating greater psychopathology. The PANSS contains three sub-scales: positive, negative and general symptoms.Range: 7-112. Higher values represent a worse outcome.
Secondary Outcome Measures
Jumping to conclusions. (Brett-Jones et al. 1987).
Three different computer tasks were used in the study. In Task 1, jars contained balls of two different colors; in one of them the proportion was 85 black versus 15 orange balls and in the other the ratio was reversed. Task 2 was the same as Task 1 but with a proportion of 60:40 in each jar. Finally, Task 3 was similar to Task 2 but instead of balls, the jars contained positive or negative comments with a proportion of 60:40. The patients had to decide which to jar belonged the extracted balls or comments. At all times the participants had information about the balls previously extracted, in order to control the effect of memory. The subjects could remove as many balls as needed to make their final decision (Garety et al., 2005). JTC was considered as taking a decision after extracting 1 or 2 balls.Dichotomous: yes/no. A "yes" represents a worse outcome
Jumping to conclusions. (Brett-Jones et al. 1987).
Three different computer tasks were used in the study. In Task 1, jars contained balls of two different colors; in one of them the proportion was 85 black versus 15 orange balls and in the other the ratio was reversed. Task 2 was the same as Task 1 but with a proportion of 60:40 in each jar. Finally, Task 3 was similar to Task 2 but instead of balls, the jars contained positive or negative comments with a proportion of 60:40. The patients had to decide which to jar belonged the extracted balls or comments. At all times the participants had information about the balls previously extracted, in order to control the effect of memory. The subjects could remove as many balls as needed to make their final decision (Garety et al., 2005). JTC was considered as taking a decision after extracting 1 or 2 balls.Dichotomous: yes/no. A "yes" represents a worse outcome
Jumping to conclusions. (Brett-Jones et al. 1987).
Three different computer tasks were used in the study. In Task 1, jars contained balls of two different colors; in one of them the proportion was 85 black versus 15 orange balls and in the other the ratio was reversed. Task 2 was the same as Task 1 but with a proportion of 60:40 in each jar. Finally, Task 3 was similar to Task 2 but instead of balls, the jars contained positive or negative comments with a proportion of 60:40. The patients had to decide which to jar belonged the extracted balls or comments. At all times the participants had information about the balls previously extracted, in order to control the effect of memory. The subjects could remove as many balls as needed to make their final decision (Garety et al., 2005). JTC was considered as taking a decision after extracting 1 or 2 balls.Dichotomous: yes/no. A "yes" represents a worse outcome
BCIS. Beck Cognitive and Insight Scale. (Beck et al., 2004; Gutierrez-Zotes et al., 2012)
The Beck Cognitive Insight Scale. this scale is a self-registering measure of 15 items .which evaluates how the patients assess their own judgement. It has two dimensions; self-reflection (R) (9 items), and self-certainty (C) (6 items). A compound index of cognitive insight is obtained as the subtraction of self-certainty from self-reflection (R-C).Range: 0-45. Higher values represent a better outcome
BCIS. Beck Cognitive and Insight Scale. (Beck et al., 2004; Gutierrez-Zotes et al., 2012)
The Beck Cognitive Insight Scale. this scale is a self-registering measure of 15 items .which evaluates how the patients assess their own judgement. It has two dimensions; self-reflection (R) (9 items), and self-certainty (C) (6 items). A compound index of cognitive insight is obtained as the subtraction of self-certainty from self-reflection (R-C).Range: 0-45. Higher values represent a better outcome
BCIS. Beck Cognitive and Insight Scale. (Beck et al., 2004; Gutierrez-Zotes et al., 2012)
The Beck Cognitive Insight Scale. this scale is a self-registering measure of 15 items .which evaluates how the patients assess their own judgement. It has two dimensions; self-reflection (R) (9 items), and self-certainty (C) (6 items). A compound index of cognitive insight is obtained as the subtraction of self-certainty from self-reflection (R-C).Range: 0-45. Higher values represent a better outcome
IPSAQ. Internal, Personal and Situational Attribution Questionnaire. (Kinderman & Bentall, 1996)
The scale assess the attributional style in 32 situations. Personalizing Bias (PB) indicates the proportion of external attributions for negative events which are personal as opposed to situational. A PB score of greater than 0.5 therefore represents a greater tendency to use personal rather than situational external attributions for negative events.
IPSAQ. Internal, Personal and Situational Attribution Questionnaire. (Kinderman & Bentall, 1996)
The scale assess the attributional style in 32 situations. Personalizing Bias (PB) indicates the proportion of external attributions for negative events which are personal as opposed to situational. A PB score of greater than 0.5 therefore represents a greater tendency to use personal rather than situational external attributions for negative events.
IPSAQ. Internal, Personal and Situational Attribution Questionnaire. (Kinderman & Bentall, 1996)
The scale assess the attributional style in 32 situations. Personalizing Bias (PB) indicates the proportion of external attributions for negative events which are personal as opposed to situational. A PB score of greater than 0.5 therefore represents a greater tendency to use personal rather than situational external attributions for negative events.
The Hinting Task. (Corcoran et al. 1995; Gil et al. 2012)
The Scale assess Theory of Mind.Possible range: 0-12. Higher values represent a better outcome
The Hinting Task. (Corcoran et al. 1995; Gil et al. 2012)
The Scale assess Theory of Mind. Possible range: 0-12. Higher values represent a better outcome
The Hinting Task. (Corcoran et al. 1995; Gil et al. 2012)
The Scale assess Theory of Mind. Possible range: 0-12. Higher values represent a better outcome
Emotional Recognition Test Faces. (Baron-Cohen et al. 1997)
20 photographs that express ten basic and ten complex emotions.Possible range: 0-20. Higher values represent a better outcome
Emotional Recognition Test Faces. (Baron-Cohen et al. 1997)
20 photographs that express ten basic and ten complex emotions. Possible range: 0-20. Higher values represent a better outcome
Emotional Recognition Test Faces. (Baron-Cohen et al. 1997)
20 photographs that express ten basic and ten complex emotions.Possible range: 0-20. Higher values represent a better outcome
MASC. (Lahera et al.2014).
A Movie for the Assessment of Social Cognition. Spanish Validation. 46 multiple-choice questions about the emotions, thoughts or intentions of the protagonists.
Only one answer out of four is correct. The four choices of each answer include, (1) correct attribution of ToM to the characters of the film, (2) excessive ToM errors (a mental state that is attributed when there is no reason to), (3) reduced ToM errors (a present mental state that is not attributed) and (4) total absence of mental inference (a physical causality attribution instead of a mental state). These errors could be classified as overmentalization, undermentalization and absence of mentalization.
Full Information
NCT ID
NCT04429412
First Posted
June 1, 2020
Last Updated
June 10, 2020
Sponsor
Fundació Sant Joan de Déu
Collaborators
Parc Sanitari Sant Joan de Déu, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, Servicio Andaluz Jaén y Málaga, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Parc de Salut Mar, Centre d'Higiene Mental Les Corts, Institut Pere Mata, Institut Assistència Sanitària Girona, Hospital Clínico Universitario de Valencia
1. Study Identification
Unique Protocol Identification Number
NCT04429412
Brief Title
Effectiveness of the Individualized Metacognitive Training (EMC+) in People With Psychosis of Brief Evolution
Official Title
Effectiveness of the Individualized Metacognitive Training (EMC+) in People With Psychosis of Brief Evolution
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
September 1, 2016 (Actual)
Study Completion Date
September 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Sant Joan de Déu
Collaborators
Parc Sanitari Sant Joan de Déu, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, Servicio Andaluz Jaén y Málaga, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Parc de Salut Mar, Centre d'Higiene Mental Les Corts, Institut Pere Mata, Institut Assistència Sanitària Girona, Hospital Clínico Universitario de Valencia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The main aim of the study is to evaluate the effectiveness of Individualized Meta-Cognitive Training (EMC +), in people with psychosis of brief evolution on symptoms, especially on positive symptoms. Secondary aims would be to assess the effect of EMC+ in metacognition, psychosocial and neuropsychological functioning, and to assess the maintenance of program effects on 6 months.
Detailed Description
This is a randomized clinical trial in which some patients receive the EMC+ and others treatment as usual.The evaluator will be blind to the group to which the patients belong. The sample for the overall project will be a total of 70 people with a diagnosis of psychotic spectrum, less than 5 years of experience and with a score => 3 positive PANSS (last month) and treated in one of the participating institutions. The evaluation was performed at baseline, at post-treatment and at 6 months follow up. Symptoms, metacognition, psychosocial and neuropsychological functioning were assessed.
The EMC consists of 10 therapeutic units with weekly sessions of 45-60 minutes. The material available for the Individualized Metacognitive Training (EMC) program is made up of power-point presentations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brief Psychotic Disorder, Psychosis; Episode
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a randomized clinical trial in which some patients receive the EMC+ and others treatment as usual.
Masking
Outcomes Assessor
Masking Description
The evaluator will be blind to the group that owns the patients included.
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metacognitive Training (MCT+)
Arm Type
Experimental
Arm Description
MCT+ combines the process-oriented approach of metacognitive group training with elements of individual cognitive-behavioral therapy.
The metacognitive training program is comprised of 10 modules targeting common cognitive errors in schizophrenia. (Moritz et al, 2013).
The modules are: 1:Therapeutic alliance, 2: Introducyion to MCT+, 3:Disease model, 4: Attributional style, 5: Decision making, 6: Changing beliefs, 7: Empathizing, 8: Memory, 9: Depression and self-steem, 10: Relapse prevention.
The treatment consist of 10 weekly sessions of 45-60 minutes.
Arm Title
TAU
Arm Type
No Intervention
Arm Description
Treatment as usual.
Intervention Type
Behavioral
Intervention Name(s)
MCT+
Intervention Description
Metacognitive training
Primary Outcome Measure Information:
Title
PANSS. Positive and Negative Syndrome Scale. (Kay et al., 1987; Peralta and Cuesta, 1994)
Description
The Positive and Negative Syndrome Scale (PANSS). This scale measures 30 symptoms on a scale of 1-7, with higher scores indicating greater psychopathology. The PANSS contains three sub-scales: positive, negative and general symptoms. Range: 7-112. Higher values represent a worse outcome.
Time Frame
baseline.
Title
PANSS. Positive and Negative Syndrome Scale. (Kay et al., 1987; Peralta and Cuesta, 1994)
Description
The Positive and Negative Syndrome Scale (PANSS). This scale measures 30 symptoms on a scale of 1-7, with higher scores indicating greater psychopathology. The PANSS contains three sub-scales: positive, negative and general symptoms.Range: 7-112. Higher values represent a worse outcome.
Time Frame
immediately after the intervention
Title
PANSS. Positive and Negative Syndrome Scale. (Kay et al., 1987; Peralta and Cuesta, 1994)
Description
The Positive and Negative Syndrome Scale (PANSS). This scale measures 30 symptoms on a scale of 1-7, with higher scores indicating greater psychopathology. The PANSS contains three sub-scales: positive, negative and general symptoms.Range: 7-112. Higher values represent a worse outcome.
Time Frame
6 months follow-up
Secondary Outcome Measure Information:
Title
Jumping to conclusions. (Brett-Jones et al. 1987).
Description
Three different computer tasks were used in the study. In Task 1, jars contained balls of two different colors; in one of them the proportion was 85 black versus 15 orange balls and in the other the ratio was reversed. Task 2 was the same as Task 1 but with a proportion of 60:40 in each jar. Finally, Task 3 was similar to Task 2 but instead of balls, the jars contained positive or negative comments with a proportion of 60:40. The patients had to decide which to jar belonged the extracted balls or comments. At all times the participants had information about the balls previously extracted, in order to control the effect of memory. The subjects could remove as many balls as needed to make their final decision (Garety et al., 2005). JTC was considered as taking a decision after extracting 1 or 2 balls.Dichotomous: yes/no. A "yes" represents a worse outcome
Time Frame
baseline
Title
Jumping to conclusions. (Brett-Jones et al. 1987).
Description
Three different computer tasks were used in the study. In Task 1, jars contained balls of two different colors; in one of them the proportion was 85 black versus 15 orange balls and in the other the ratio was reversed. Task 2 was the same as Task 1 but with a proportion of 60:40 in each jar. Finally, Task 3 was similar to Task 2 but instead of balls, the jars contained positive or negative comments with a proportion of 60:40. The patients had to decide which to jar belonged the extracted balls or comments. At all times the participants had information about the balls previously extracted, in order to control the effect of memory. The subjects could remove as many balls as needed to make their final decision (Garety et al., 2005). JTC was considered as taking a decision after extracting 1 or 2 balls.Dichotomous: yes/no. A "yes" represents a worse outcome
Time Frame
immediately after the intervention
Title
Jumping to conclusions. (Brett-Jones et al. 1987).
Description
Three different computer tasks were used in the study. In Task 1, jars contained balls of two different colors; in one of them the proportion was 85 black versus 15 orange balls and in the other the ratio was reversed. Task 2 was the same as Task 1 but with a proportion of 60:40 in each jar. Finally, Task 3 was similar to Task 2 but instead of balls, the jars contained positive or negative comments with a proportion of 60:40. The patients had to decide which to jar belonged the extracted balls or comments. At all times the participants had information about the balls previously extracted, in order to control the effect of memory. The subjects could remove as many balls as needed to make their final decision (Garety et al., 2005). JTC was considered as taking a decision after extracting 1 or 2 balls.Dichotomous: yes/no. A "yes" represents a worse outcome
Time Frame
6 months follow-up
Title
BCIS. Beck Cognitive and Insight Scale. (Beck et al., 2004; Gutierrez-Zotes et al., 2012)
Description
The Beck Cognitive Insight Scale. this scale is a self-registering measure of 15 items .which evaluates how the patients assess their own judgement. It has two dimensions; self-reflection (R) (9 items), and self-certainty (C) (6 items). A compound index of cognitive insight is obtained as the subtraction of self-certainty from self-reflection (R-C).Range: 0-45. Higher values represent a better outcome
Time Frame
baseline
Title
BCIS. Beck Cognitive and Insight Scale. (Beck et al., 2004; Gutierrez-Zotes et al., 2012)
Description
The Beck Cognitive Insight Scale. this scale is a self-registering measure of 15 items .which evaluates how the patients assess their own judgement. It has two dimensions; self-reflection (R) (9 items), and self-certainty (C) (6 items). A compound index of cognitive insight is obtained as the subtraction of self-certainty from self-reflection (R-C).Range: 0-45. Higher values represent a better outcome
Time Frame
immediately after the intervention
Title
BCIS. Beck Cognitive and Insight Scale. (Beck et al., 2004; Gutierrez-Zotes et al., 2012)
Description
The Beck Cognitive Insight Scale. this scale is a self-registering measure of 15 items .which evaluates how the patients assess their own judgement. It has two dimensions; self-reflection (R) (9 items), and self-certainty (C) (6 items). A compound index of cognitive insight is obtained as the subtraction of self-certainty from self-reflection (R-C).Range: 0-45. Higher values represent a better outcome
Time Frame
6 months follow-up
Title
IPSAQ. Internal, Personal and Situational Attribution Questionnaire. (Kinderman & Bentall, 1996)
Description
The scale assess the attributional style in 32 situations. Personalizing Bias (PB) indicates the proportion of external attributions for negative events which are personal as opposed to situational. A PB score of greater than 0.5 therefore represents a greater tendency to use personal rather than situational external attributions for negative events.
Time Frame
baseline
Title
IPSAQ. Internal, Personal and Situational Attribution Questionnaire. (Kinderman & Bentall, 1996)
Description
The scale assess the attributional style in 32 situations. Personalizing Bias (PB) indicates the proportion of external attributions for negative events which are personal as opposed to situational. A PB score of greater than 0.5 therefore represents a greater tendency to use personal rather than situational external attributions for negative events.
Time Frame
immediately after the intervention
Title
IPSAQ. Internal, Personal and Situational Attribution Questionnaire. (Kinderman & Bentall, 1996)
Description
The scale assess the attributional style in 32 situations. Personalizing Bias (PB) indicates the proportion of external attributions for negative events which are personal as opposed to situational. A PB score of greater than 0.5 therefore represents a greater tendency to use personal rather than situational external attributions for negative events.
Time Frame
6 months follow-up
Title
The Hinting Task. (Corcoran et al. 1995; Gil et al. 2012)
Description
The Scale assess Theory of Mind.Possible range: 0-12. Higher values represent a better outcome
Time Frame
baseline
Title
The Hinting Task. (Corcoran et al. 1995; Gil et al. 2012)
Description
The Scale assess Theory of Mind. Possible range: 0-12. Higher values represent a better outcome
Time Frame
immediately after the intervention
Title
The Hinting Task. (Corcoran et al. 1995; Gil et al. 2012)
Description
The Scale assess Theory of Mind. Possible range: 0-12. Higher values represent a better outcome
Time Frame
6 months follow-up
Title
Emotional Recognition Test Faces. (Baron-Cohen et al. 1997)
Description
20 photographs that express ten basic and ten complex emotions.Possible range: 0-20. Higher values represent a better outcome
Time Frame
baseline
Title
Emotional Recognition Test Faces. (Baron-Cohen et al. 1997)
Description
20 photographs that express ten basic and ten complex emotions. Possible range: 0-20. Higher values represent a better outcome
Time Frame
immediately after the intervention
Title
Emotional Recognition Test Faces. (Baron-Cohen et al. 1997)
Description
20 photographs that express ten basic and ten complex emotions.Possible range: 0-20. Higher values represent a better outcome
Time Frame
6 months follow-up
Title
MASC. (Lahera et al.2014).
Description
A Movie for the Assessment of Social Cognition. Spanish Validation. 46 multiple-choice questions about the emotions, thoughts or intentions of the protagonists.
Only one answer out of four is correct. The four choices of each answer include, (1) correct attribution of ToM to the characters of the film, (2) excessive ToM errors (a mental state that is attributed when there is no reason to), (3) reduced ToM errors (a present mental state that is not attributed) and (4) total absence of mental inference (a physical causality attribution instead of a mental state). These errors could be classified as overmentalization, undermentalization and absence of mentalization.
Time Frame
immediately after the intervention
Other Pre-specified Outcome Measures:
Title
SFS. Social Functioning Scale.(Birchwood et al, 1990; Torres y Olivares, 2000).
Description
This scale assess social functioning in people with psychotic disorders. Range: 45-195
Time Frame
baseline
Title
SFS. Social Functioning Scale.(Birchwood et al, 1990; Torres y Olivares, 2000).
Description
This scale assess social functioning in people with psychotic disorders.Range: 45-195
Time Frame
immediately after the intervention
Title
SFS. Social Functioning Scale.(Birchwood et al, 1990; Torres y Olivares, 2000).
Description
This scale assess social functioning in people with psychotic disorders.Range: 45-195
Time Frame
6 months follow-up
Title
WCST(Wisconsin Card Sorting Test, Bergs et al, 1948)
Description
measure of executive function. Categories completed and perseverative errors. Higher values represent a better outcome.
Time Frame
baseline
Title
WCST(Wisconsin Card Sorting Test, Bergs et al, 1948)
Description
measure of executive function. Categories completed and perseverative errors. Higher values represent a better outcome.
Time Frame
immediately after the intervention
Title
WCST(Wisconsin Card Sorting Test, Bergs et al, 1948)
Description
measure of executive function. Categories completed and perseverative errors. Higher values represent a better outcome.
Time Frame
6 months follow-up
Title
Test Stroop (Stroop, 1935)
Description
flexibility and inhibition of automatic responses.Higher values represent a better outcome.
Time Frame
baseline
Title
Test Stroop (Stroop, 1935)
Description
flexibility and inhibition of automatic responses.Higher values represent a better outcome.
Time Frame
immediately after the intervention
Title
Test Stroop (Stroop, 1935)
Description
flexibility and inhibition of automatic responses.Higher values represent a better outcome.
Time Frame
6 months follow-up
Title
TMT A B (Trail Making Test, Reitan, 1993)
Description
visual attention and task switching. Higher values represent a worse outcome.
Time Frame
baseline
Title
TMT A B (Trail Making Test, Reitan, 1993)
Description
visual attention and task switching. Higher values represent a worse outcome.
Time Frame
immediately after the intervention
Title
TMT A B (Trail Making Test, Reitan, 1993)
Description
visual attention and task switching. Higher values represent a worse outcome.
Time Frame
6 months follow-up
Title
CPT-IP (Continous Performance Test, Matrics)
Description
measure of attention. Higher values represent a better outcome.
Time Frame
baseline
Title
CPT-IP (Continous Performance Test, Matrics)
Description
measure of attention.Higher values represent a better outcome.
Time Frame
6 months follow-up
Title
TAVEC (Verbal Learning Test), Benedet and Aleixandre 1998)
Description
measure of verbal memory.Higher values represent a better outcome.
Time Frame
baseline
Title
TAVEC (Verbal Learning Test), Benedet and Aleixandre 1998)
Description
measure of verbal memory. Higher values represent a better outcome.
Time Frame
6 months follow-up
Title
WAIS-III (Weschler Adults Intelligence Scale, Wechsler 1955)
Description
vocabulary subscale. Higher values represent a better outcome.
Time Frame
baseline
Title
WAIS-III (Weschler Adults Intelligence Scale, Wechsler 1955)
Description
digits subscale. Higher values represent a better outcome.
Time Frame
baseline
Title
WAIS-III (Weschler Adults Intelligence Scale, Wechsler 1955)
Description
digits subscale. Higher values represent a better outcome.
Time Frame
immediately after the intervention
Title
WAIS-III (Weschler Adults Intelligence Scale, Wechsler 1955)
Description
digits subscale. Higher values represent a better outcome.
Time Frame
6 months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of : schizophrenia, schizoaffective disorder, brief psychotic disorder, delusional disorder, schizophreniform disorder, psychotic disorder not otherwise specified.
Less than 5 years of evolution.
Score at or above 4 on the PANSS during the last year (delusions, grandiosity, suspiciousness).
Exclusion Criteria:
Traumatic brain injury, dementia, or intellectual disability (premorbid IQ ≤70).
Substance dependence.
Score at or above 5 on the PANSS ( Hostility and Uncooperativeness); score at or above 6 on the PANSS (suspiciousness).
12. IPD Sharing Statement
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Effectiveness of the Individualized Metacognitive Training (EMC+) in People With Psychosis of Brief Evolution
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