search
Back to results

Effectiveness of Meta-Cognitive Training (EMC) in People With Psychosis of Brief Evolution.

Primary Purpose

Psychosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Meta-cognitive Training
Psychoeducational group
Sponsored by
Fundació Sant Joan de Déu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychosis focused on measuring meta-cognition, positive symptoms, early phases, schizophrenia

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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:

  • Neurological disorder which impairs cognition.
  • Intellectual Disability.
  • 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

    Active Comparator

    Arm Label

    Meta-cognitive Training

    Psychoeducational group

    Arm Description

    The metacognitive training program is comprised of eight modules targeting common cognitive errors in schizophrenia. The modules are : attributional distortions (module 1), a jumping to conclusions bias (module 2 and 7), a bias against disconfirmatory evidence (module 3), deficits in theory of mind (module 4 and 6), over-confidence in memory errors (module 5) and depressive cognitive patterns (module 8). The treatment group consist of 8 weekly sessions of 45-60 minutes with a total of 4 to 8 patients per group.

    In the control group the modules worked were: 1. Healthy Habits, 2. Risk Behaviors, 3. Prevention of relapse, 4 and 5.Videoforum, 6. Resources of work and development of curriculum vitae 7. Leisure activities, and 8. Resources of the community. The psychoeducational group consist of 8 weekly sessions of 45-60 minutes with a total of 4 to 8 patients per group.

    Outcomes

    Primary Outcome Measures

    PANSS. Positive and Negative Syndrome Scale
    The Positive and Negative Syndrome Scale (PANSS)(Kay et al., 1987; Peralta and Cuesta, 1994) 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.
    PSYRATS. Psychotic Symptoms Rating Scale
    The PSYRATS (Haddock et al, 1999; Gonzalez et al, 2003). This scale assess delusions in 6 items.

    Secondary Outcome Measures

    Jumping to conclusions
    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.
    BCIS. Beck Cognitive and Insight Scale
    The Beck Cognitive Insight Scale (BCSI; Beck et al., 2004; Gutierrez-Zotes et al., 2012) 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).
    IPSAQ. Internal, Personal and Situational Attribution Questionnaire.
    The scale assess the attributional style in 32 situations.
    Hinking Task
    The Scale assess Theory of Mind. For the porpouse of the study we selected 3 different situations in each assessment
    TCI scale "Test de Creencias Irracionales"
    This scale assess irrational beliefs in ten subscales:Need for acceptance by others, High self-expectations, blame, Intolerance to frustration, Worry and anxiety, Emotional irresponsibility, Avoidance of problems, dependency, helplessness, perfectionism.

    Full Information

    First Posted
    January 13, 2015
    Last Updated
    January 20, 2015
    Sponsor
    Fundació Sant Joan de Déu
    Collaborators
    Parc Sanitari Sant Joan de Déu, Corporacion Parc Tauli, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Fundación para la Investigación del Hospital Clínico de Valencia, Centre d'Higiene Mental Les Corts, Institut d´Assistència Sanitària Girona, Servicio Andaluz de Salud de Granada, Málaga y Jaén
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02340559
    Brief Title
    Effectiveness of Meta-Cognitive Training (EMC) in People With Psychosis of Brief Evolution.
    Official Title
    Effectiveness of Meta-Cognitive Training (EMC) on Symptmos, Metacognition, Social and Neuropsychological Functioning in People With Psychosis of Brief Evolution
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2012 (undefined)
    Primary Completion Date
    September 2013 (Actual)
    Study Completion Date
    December 2014 (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, Corporacion Parc Tauli, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Fundación para la Investigación del Hospital Clínico de Valencia, Centre d'Higiene Mental Les Corts, Institut d´Assistència Sanitària Girona, Servicio Andaluz de Salud de Granada, Málaga y Jaén

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to assess the effectiveness of Meta-Cognitive Training (EMC) in people with a brief psychotic disorder, especially positive symptoms. The secondary objectives would be to assess the effect of EMC on metacognition (cognitive distortions and deficits in theory of mind), psychosocial functioning and quality of life, neuropsychological functioning and gender, as well as determine the changes produced by EMC in the insight of each session and the maintenance of the effects of EMC program at six months of treatment.
    Detailed Description
    The study is a randomized clinical trial in which a group will receive the Meta-Cognitive Training (EMC) and a control group will receive a journal workshop. The evaluator will be blind to the group that owns the patients included. The total simple will be of 122 people with a psychotic disorder, less than 5 years of evolution and a score at or above 3 on the PANSS during the last year. Patients should be attended in one of the next services: Parc Sanitari Sant Joan de Déu, Corporació Sanitària Parc Taulí, Hospital de la Santa Creu i Sant Pau, Hospital Clínic de Valencia, Centre d´Higiene Mental de les Corts, Institut d´Assitència Sanitària Girona, Servicio Andaluz de Granada, Málaga y Jaén. The assessment was performed at baseline, at the end of treatment and six month follow-up. The assessment includes: psychopathology and insight ( PANSS, PSYRATS, PDI, GAF, BDI, BCIS, Sumd), meta-cognition (jumping to conclusions, IPSAQ, TCI), neuropsychology (WCST, TMT, CPT-II, TAVEC, WAIS) and social functioning and quality of life (EFS, DAS-SV, SLDS). The insight will be assessed at the final of each session (BCIS). The treatment and control group consist of 8 weekly sessions of 45-60 minutes with a total of 4 to 8 patients per group. The EMC group material is translated and validated in Spanish by investigators of the team. The primary analysis variable is the difference between the scores of experimental and control group in the symptoms scales (especially positive). Secondary outcomes will change in other assessments of social functioning, metacognition (cognitive distortions and theory of mind) and neuropsychological variables. Were analyzed using regression and ANCOVA methods with SPSS 19.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psychosis
    Keywords
    meta-cognition, positive symptoms, early phases, schizophrenia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    122 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Meta-cognitive Training
    Arm Type
    Experimental
    Arm Description
    The metacognitive training program is comprised of eight modules targeting common cognitive errors in schizophrenia. The modules are : attributional distortions (module 1), a jumping to conclusions bias (module 2 and 7), a bias against disconfirmatory evidence (module 3), deficits in theory of mind (module 4 and 6), over-confidence in memory errors (module 5) and depressive cognitive patterns (module 8). The treatment group consist of 8 weekly sessions of 45-60 minutes with a total of 4 to 8 patients per group.
    Arm Title
    Psychoeducational group
    Arm Type
    Active Comparator
    Arm Description
    In the control group the modules worked were: 1. Healthy Habits, 2. Risk Behaviors, 3. Prevention of relapse, 4 and 5.Videoforum, 6. Resources of work and development of curriculum vitae 7. Leisure activities, and 8. Resources of the community. The psychoeducational group consist of 8 weekly sessions of 45-60 minutes with a total of 4 to 8 patients per group.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Meta-cognitive Training
    Intervention Type
    Behavioral
    Intervention Name(s)
    Psychoeducational group
    Primary Outcome Measure Information:
    Title
    PANSS. Positive and Negative Syndrome Scale
    Description
    The Positive and Negative Syndrome Scale (PANSS)(Kay et al., 1987; Peralta and Cuesta, 1994) 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.
    Time Frame
    baseline, 2 months (post-treatment) and 6 months of follow-up
    Title
    PSYRATS. Psychotic Symptoms Rating Scale
    Description
    The PSYRATS (Haddock et al, 1999; Gonzalez et al, 2003). This scale assess delusions in 6 items.
    Time Frame
    baseline, 2 months (post-treatment) and 6 months of follow-up
    Secondary Outcome Measure Information:
    Title
    Jumping to conclusions
    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.
    Time Frame
    baseline, 2 months (post-treatment) and 6 months of follow-up
    Title
    BCIS. Beck Cognitive and Insight Scale
    Description
    The Beck Cognitive Insight Scale (BCSI; Beck et al., 2004; Gutierrez-Zotes et al., 2012) 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).
    Time Frame
    baseline, 2 months (post-treatment) and 6 months of follow-up. Moreover in the intervention group this scale was assessed at the end of each session
    Title
    IPSAQ. Internal, Personal and Situational Attribution Questionnaire.
    Description
    The scale assess the attributional style in 32 situations.
    Time Frame
    baseline, 2 months (post-treatment) and 6 months of follow-up.
    Title
    Hinking Task
    Description
    The Scale assess Theory of Mind. For the porpouse of the study we selected 3 different situations in each assessment
    Time Frame
    baseline, 2 months (post-treatment) and 6 months of follow-up.
    Title
    TCI scale "Test de Creencias Irracionales"
    Description
    This scale assess irrational beliefs in ten subscales:Need for acceptance by others, High self-expectations, blame, Intolerance to frustration, Worry and anxiety, Emotional irresponsibility, Avoidance of problems, dependency, helplessness, perfectionism.
    Time Frame
    baseline, 2 months (post-treatment) and 6 months of follow-up.
    Other Pre-specified Outcome Measures:
    Title
    SFS "Social Functioning Scale"
    Description
    This scale assess social functioning in people with psychotic disorders (Birchwood et al, 1990; Torres y Olivares, 2000).
    Time Frame
    baseline, 2 months (post-treatment) and 6 months of follow-up.
    Title
    Neuropsychological battery
    Description
    A neuropsychological battery was included. The test included were WCST(Wisconsin Card Sorting Test, Bergs et al, 1948)measure of executive function; Test Stroop (Stroop, 1935) flexibility and inhibition of automatic responses; TMTA-B (Trail Making Test, Reitan, 1993) visual attention and task switching; CPT (Continous Performance Test, Conners 2000) this scale asses inattentiveness and impulsivity; TAVEC (Test Aprendizaje Verbal España Complutense, Benedet and Aleixandre 1998) this scale asses memory; WAIS (Weschler Adults Intelligence Scale, Wechsler 1955)subscales of digits and vocabulary.
    Time Frame
    baseline and 6 months of 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: Neurological disorder which impairs cognition. Intellectual Disability. Score at or above 5 on the PANSS ( Hostility and Uncooperativeness); score at or above 6 on the PANSS (suspiciousness).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Susana Ochoa, PhD
    Organizational Affiliation
    Parc Sanitari Sant Joan de Déu
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Marisa Barrigón, PhD
    Organizational Affiliation
    Servicio Andaluz de Salud. Granada
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Fermín González
    Organizational Affiliation
    Servicio Andaluz de Salud. Jaen
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Isabel Ruiz
    Organizational Affiliation
    Servicio Andaluz de Salud. Málaga
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Eva Grasa
    Organizational Affiliation
    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Esther Pousa, PhD
    Organizational Affiliation
    Corporacion Parc Tauli
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Esther Lorente, PhD
    Organizational Affiliation
    Hospital Clínic de València
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Ana Barajas
    Organizational Affiliation
    Centre d'Higiene Mental de les Corts
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Jordi Cid
    Organizational Affiliation
    Institut d'Assistència Sanitària de Girona
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Raquel López, MS
    Organizational Affiliation
    Parc Sanitari Sant Joan de Déu
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    31855037
    Citation
    Salas-Sender M, Lopez-Carrilero R, Barajas A, Lorente-Rovira E, Pousa E, Barrigon ML, Grasa E, Ruiz-Delgado I, Gonzalez-Higueras F, Cid J, Aznar A, Pelaez T, Birules I, Moritz S, The Spanish Metacognition Study Group, Ochoa S. Gender differences in response to metacognitive training in people with first-episode psychosis. J Consult Clin Psychol. 2020 Jun;88(6):516-525. doi: 10.1037/ccp0000468. Epub 2019 Dec 19.
    Results Reference
    derived

    Learn more about this trial

    Effectiveness of Meta-Cognitive Training (EMC) in People With Psychosis of Brief Evolution.

    We'll reach out to this number within 24 hrs