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

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ClinicalTrials.gov Identifier: NCT02340559
Recruitment Status : Completed
First Posted : January 16, 2015
Last Update Posted : January 21, 2015
Sponsor:
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
Information provided by (Responsible Party):
Fundació Sant Joan de Déu

Tracking Information
First Submitted Date  ICMJE January 13, 2015
First Posted Date  ICMJE January 16, 2015
Last Update Posted Date January 21, 2015
Study Start Date  ICMJE August 2012
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2015)
  • PANSS. Positive and Negative Syndrome Scale [ Time Frame: baseline, 2 months (post-treatment) and 6 months of follow-up ]
    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 [ Time Frame: baseline, 2 months (post-treatment) and 6 months of follow-up ]
    The PSYRATS (Haddock et al, 1999; Gonzalez et al, 2003). This scale assess delusions in 6 items.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2015)
  • Jumping to conclusions [ Time Frame: baseline, 2 months (post-treatment) and 6 months of follow-up ]
    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 [ 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 ]
    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. [ Time Frame: baseline, 2 months (post-treatment) and 6 months of follow-up. ]
    The scale assess the attributional style in 32 situations.
  • Hinking Task [ Time Frame: baseline, 2 months (post-treatment) and 6 months of follow-up. ]
    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" [ Time Frame: baseline, 2 months (post-treatment) and 6 months of follow-up. ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 20, 2015)
  • SFS "Social Functioning Scale" [ Time Frame: baseline, 2 months (post-treatment) and 6 months of follow-up. ]
    This scale assess social functioning in people with psychotic disorders (Birchwood et al, 1990; Torres y Olivares, 2000).
  • Neuropsychological battery [ Time Frame: baseline and 6 months of follow-up. ]
    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.
Original Other Pre-specified Outcome Measures
 (submitted: January 15, 2015)
  • SFS "Social Functioning Scale" [ Time Frame: baseline, 2 months (post-treatment) and 6 months of follow-up. ]
    This scale assess social functioning in people with psychotic disorders (Birchwood et al, 1990; Torres y Olivares, 2000).
  • Neuropsychological battery [ Time Frame: baseline and 6 months of follow-up. ]
    A neuropsychological battery was included. The test included were WCST, Stroop, TMTA-B, CPT, TAVEC, WAIS
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Meta-Cognitive Training (EMC) in People With Psychosis of Brief Evolution.
Official Title  ICMJE Effectiveness of Meta-Cognitive Training (EMC) on Symptmos, Metacognition, Social and Neuropsychological Functioning in People With Psychosis of Brief Evolution
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Psychosis
Intervention  ICMJE
  • Behavioral: Meta-cognitive Training
  • Behavioral: Psychoeducational group
Study Arms  ICMJE
  • Experimental: Meta-cognitive Training

    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.

    Intervention: Behavioral: Psychoeducational group
  • Active Comparator: Psychoeducational 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.
    Intervention: Behavioral: Meta-cognitive Training
Publications * Salas-Sender M, López-Carrilero R, Barajas A, Lorente-Rovira E, Pousa E, Barrigón ML, Grasa E, Ruiz-Delgado I, González-Higueras F, Cid J, Aznar A, Pélaez T, Birulés I, Moritz S, Ochoa S; Spanish Metacognition Study Group. Gender differences in response to metacognitive training in people with first-episode psychosis. J Consult Clin Psychol. 2019 Dec 19. doi: 10.1037/ccp0000468. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 15, 2015)
122
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02340559
Other Study ID Numbers  ICMJE PI11/01347
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fundació Sant Joan de Déu
Study Sponsor  ICMJE Fundació Sant Joan de Déu
Collaborators  ICMJE
  • 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
Investigators  ICMJE
Principal Investigator: Susana Ochoa, PhD Parc Sanitari Sant Joan de Déu
Study Chair: Marisa Barrigón, PhD Servicio Andaluz de Salud. Granada
Study Chair: Fermín González Servicio Andaluz de Salud. Jaen
Study Chair: Isabel Ruiz Servicio Andaluz de Salud. Málaga
Study Chair: Eva Grasa Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study Chair: Esther Pousa, PhD Corporacion Parc Tauli
Study Chair: Esther Lorente, PhD Hospital Clínic de València
Study Chair: Ana Barajas Centre d'Higiene Mental de les Corts
Study Chair: Jordi Cid Institut d'Assistència Sanitària de Girona
Study Chair: Raquel López, MS Parc Sanitari Sant Joan de Déu
PRS Account Fundació Sant Joan de Déu
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP