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

Fundació Sant Joan de Déu

Status: Completed

Conditions: Psychosis

Treatments: Behavioral: Psychoeducational group; Behavioral: Meta-cognitive Training

Study type: Interventional

Funder types: Other

Identifiers

NCT02340559

PI11/01347

Details and patient eligibility

About

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.

Full 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.

Enrollment: 122 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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122 participants in 2 patient groups

Meta-cognitive Training

Experimental group

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.

Treatment:

Behavioral: Psychoeducational group

Psychoeducational group

Active Comparator group

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.

Treatment:

Behavioral: Meta-cognitive Training