Effectiveness of the Individualized Metacognitive Training (EMC+) in People With Psychosis of Brief Evolution

Fundació Sant Joan de Déu

Status: Completed

Conditions: Psychosis; Episode; Brief Psychotic Disorder

Treatments: Behavioral: MCT+

Study type: Interventional

Funder types: Other

Identifiers

NCT04429412

PI14/00044

Details and patient eligibility

About

The main aim of the study is to evaluate the effectiveness of Individualized Meta-Cognitive Training (EMC +), in people with psychosis of brief evolution on symptoms, especially on positive symptoms. Secondary aims would be to assess the effect of EMC+ in metacognition, psychosocial and neuropsychological functioning, and to assess the maintenance of program effects on 6 months.

Full description

This is a randomized clinical trial in which some patients receive the EMC+ and others treatment as usual.The evaluator will be blind to the group to which the patients belong. The sample for the overall project will be a total of 70 people with a diagnosis of psychotic spectrum, less than 5 years of experience and with a score => 3 positive PANSS (last month) and treated in one of the participating institutions. The evaluation was performed at baseline, at post-treatment and at 6 months follow up. Symptoms, metacognition, psychosocial and neuropsychological functioning were assessed.

The EMC consists of 10 therapeutic units with weekly sessions of 45-60 minutes. The material available for the Individualized Metacognitive Training (EMC) program is made up of power-point presentations.

Enrollment: 70 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

• Traumatic brain injury, dementia, or intellectual disability (premorbid IQ ≤70).
• Substance dependence.
• 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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70 participants in 2 patient groups

Metacognitive Training (MCT+)

Experimental group

Description:

MCT+ combines the process-oriented approach of metacognitive group training with elements of individual cognitive-behavioral therapy. The metacognitive training program is comprised of 10 modules targeting common cognitive errors in schizophrenia. (Moritz et al, 2013). The modules are: 1:Therapeutic alliance, 2: Introducyion to MCT+, 3:Disease model, 4: Attributional style, 5: Decision making, 6: Changing beliefs, 7: Empathizing, 8: Memory, 9: Depression and self-steem, 10: Relapse prevention. The treatment consist of 10 weekly sessions of 45-60 minutes.

Treatment:

Behavioral: MCT+

TAU

No Intervention group

Description:

Treatment as usual.