Psychosis Clinical Trial
Official title:
Effectiveness of Meta-Cognitive Training (EMC) on Symptmos, Metacognition, Social and Neuropsychological Functioning in People With Psychosis of Brief Evolution
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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