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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Psychosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Psychoeducational group

Intervention Type BEHAVIORAL

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.

Group Type ACTIVE_COMPARATOR

Meta-cognitive Training

Intervention Type BEHAVIORAL

Interventions

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Meta-cognitive Training

Intervention Type BEHAVIORAL

Psychoeducational group

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No