Clinical trial NCT02340559: 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
Overall status: COMPLETED
Phase: NA
Conditions: Psychosis
Keywords: meta-cognition
positive symptoms
early phases
schizophrenia
Lead sponsor: Fundació Sant Joan de Déu
Sponsor class: OTHER
Collaborators: name: Parc Sanitari Sant Joan de Déu
name: Corporacion Parc Tauli
name: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Fundación para la Investigación del Hospital Clínico de Valencia
name: Centre d'Higiene Mental Les Corts
name: Institut d´Assistència Sanitària Girona
name: Servicio Andaluz de Salud de Granada, Málaga y Jaén
First posted: 2015-01-16
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: PANSS. Positive and Negative Syndrome Scale
timeFrame: baseline, 2 months (post-treatment) and 6 months of follow-up
measure: PSYRATS. Psychotic Symptoms Rating Scale
timeFrame: baseline, 2 months (post-treatment) and 6 months of follow-up
Secondary outcomes:
measure: Jumping to conclusions
timeFrame: baseline, 2 months (post-treatment) and 6 months of follow-up
measure: BCIS. Beck Cognitive and Insight Scale
timeFrame: 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
measure: IPSAQ. Internal, Personal and Situational Attribution Questionnaire.
timeFrame: baseline, 2 months (post-treatment) and 6 months of follow-up.
measure: Hinking Task
timeFrame: baseline, 2 months (post-treatment) and 6 months of follow-up.
measure: TCI scale "Test de Creencias Irracionales"
timeFrame: baseline, 2 months (post-treatment) and 6 months of follow-up.
Other outcomes:
measure: SFS "Social Functioning Scale"
timeFrame: baseline, 2 months (post-treatment) and 6 months of follow-up.
measure: Neuropsychological battery
timeFrame: baseline and 6 months of follow-up.
Locations:
Study officials:
affiliation: Parc Sanitari Sant Joan de Déu
name: Susana Ochoa, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicio Andaluz de Salud. Granada
name: Marisa Barrigón, PhD
role: STUDY_CHAIR
affiliation: Servicio Andaluz de Salud. Jaen
name: Fermín González
role: STUDY_CHAIR
affiliation: Servicio Andaluz de Salud. Málaga
name: Isabel Ruiz
role: STUDY_CHAIR
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Eva Grasa
role: STUDY_CHAIR
affiliation: Corporacion Parc Tauli
name: Esther Pousa, PhD
role: STUDY_CHAIR
affiliation: Hospital Clínic de València
name: Esther Lorente, PhD
role: STUDY_CHAIR
affiliation: Centre d'Higiene Mental de les Corts
name: Ana Barajas
role: STUDY_CHAIR
affiliation: Institut d'Assistència Sanitària de Girona
name: Jordi Cid
role: STUDY_CHAIR
affiliation: Parc Sanitari Sant Joan de Déu
name: Raquel López, MS
role: STUDY_CHAIR
References:
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.