Effectiveness of the Individualized Metacognitive Training (EMC+) in People With Psychosis of Brief Evolution

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.

Study Overview

• Status: Completed
• Conditions: Psychosis; Episode; Brief Psychotic Disorder
• Intervention / Treatment: Behavioral: MCT+

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Metacognitive Training (MCT+); 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.	Behavioral: MCT+; Metacognitive training
NO_INTERVENTION: TAU; Treatment as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline.
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.	immediately after the intervention
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.	6 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	baseline
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	immediately after the intervention
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	6 months follow-up
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	baseline
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	immediately after the intervention
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	6 months follow-up
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.	baseline
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.	immediately after the intervention
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.	6 months follow-up
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	baseline
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	immediately after the intervention
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	6 months follow-up
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	baseline
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	immediately after the intervention
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	6 months follow-up
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.	immediately after the intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
SFS. Social Functioning Scale.(Birchwood et al, 1990; Torres y Olivares, 2000).	This scale assess social functioning in people with psychotic disorders. Range: 45-195	baseline
SFS. Social Functioning Scale.(Birchwood et al, 1990; Torres y Olivares, 2000).	This scale assess social functioning in people with psychotic disorders.Range: 45-195	immediately after the intervention
SFS. Social Functioning Scale.(Birchwood et al, 1990; Torres y Olivares, 2000).	This scale assess social functioning in people with psychotic disorders.Range: 45-195	6 months follow-up
WCST(Wisconsin Card Sorting Test, Bergs et al, 1948)	measure of executive function. Categories completed and perseverative errors. Higher values represent a better outcome.	baseline
WCST(Wisconsin Card Sorting Test, Bergs et al, 1948)	measure of executive function. Categories completed and perseverative errors. Higher values represent a better outcome.	immediately after the intervention
WCST(Wisconsin Card Sorting Test, Bergs et al, 1948)	measure of executive function. Categories completed and perseverative errors. Higher values represent a better outcome.	6 months follow-up
Test Stroop (Stroop, 1935)	flexibility and inhibition of automatic responses.Higher values represent a better outcome.	baseline
Test Stroop (Stroop, 1935)	flexibility and inhibition of automatic responses.Higher values represent a better outcome.	immediately after the intervention
Test Stroop (Stroop, 1935)	flexibility and inhibition of automatic responses.Higher values represent a better outcome.	6 months follow-up
TMT A B (Trail Making Test, Reitan, 1993)	visual attention and task switching. Higher values represent a worse outcome.	baseline
TMT A B (Trail Making Test, Reitan, 1993)	visual attention and task switching. Higher values represent a worse outcome.	immediately after the intervention
TMT A B (Trail Making Test, Reitan, 1993)	visual attention and task switching. Higher values represent a worse outcome.	6 months follow-up
CPT-IP (Continous Performance Test, Matrics)	measure of attention. Higher values represent a better outcome.	baseline
CPT-IP (Continous Performance Test, Matrics)	measure of attention.Higher values represent a better outcome.	6 months follow-up
TAVEC (Verbal Learning Test), Benedet and Aleixandre 1998)	measure of verbal memory.Higher values represent a better outcome.	baseline
TAVEC (Verbal Learning Test), Benedet and Aleixandre 1998)	measure of verbal memory. Higher values represent a better outcome.	6 months follow-up
WAIS-III (Weschler Adults Intelligence Scale, Wechsler 1955)	vocabulary subscale. Higher values represent a better outcome.	baseline
WAIS-III (Weschler Adults Intelligence Scale, Wechsler 1955)	digits subscale. Higher values represent a better outcome.	baseline
WAIS-III (Weschler Adults Intelligence Scale, Wechsler 1955)	digits subscale. Higher values represent a better outcome.	immediately after the intervention
WAIS-III (Weschler Adults Intelligence Scale, Wechsler 1955)	digits subscale. Higher values represent a better outcome.	6 months follow-up

Collaborators and Investigators

• Sponsor: Fundació Sant Joan de Déu
• Collaborators: Parc de Salut Mar; Parc Sanitari Sant Joan de Déu; Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau; Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz; Hospital Clínico Universitario de Valencia; Centre d'Higiene Mental Les Corts; Servicio Andaluz Jaén y Málaga; Institut Pere Mata; Institut Assistència Sanitària Girona

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2015
• Primary Completion (ACTUAL): September 1, 2016
• Study Completion (ACTUAL): September 1, 2018

Study Registration Dates

• First Submitted: June 1, 2020
• First Submitted That Met QC Criteria: June 10, 2020
• First Posted (ACTUAL): June 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 12, 2020
• Last Update Submitted That Met QC Criteria: June 10, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: PI14/00044

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No