Effectiveness of Meta-Cognitive Training (EMC) on Symptmos, Metacognition, Social and Neuropsychological Functioning in People With Psychosis of Brief Evolution
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Psychosis
- Sponsor
- Fundació Sant Joan de Déu
- Enrollment
- 122
- Primary Endpoint
- PANSS. Positive and Negative Syndrome Scale
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
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).
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Jumping to conclusions(baseline, 2 months (post-treatment) and 6 months of follow-up)
- BCIS. Beck Cognitive and Insight Scale(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)
- IPSAQ. Internal, Personal and Situational Attribution Questionnaire.(baseline, 2 months (post-treatment) and 6 months of follow-up.)
- Hinking Task(baseline, 2 months (post-treatment) and 6 months of follow-up.)
- TCI scale "Test de Creencias Irracionales"(baseline, 2 months (post-treatment) and 6 months of follow-up.)