Efficacy of Metacognitive Training for Schizophrenia - a Study Protocol

University Rovira i Virgili

Status: Completed

Conditions: Schizophrenia

Treatments: Other: Treatment As Usual (TAU); Behavioral: Metacognitive Training in Schizophrenia (MCT)

Study type: Interventional

Funder types: Other

Identifiers

NCT03891186

2019MCT.PT

Details and patient eligibility

About

Metacognitive training (MCT) for schizophrenia has been used in several countries, but its efficacy remains unclear. MCT is a program group that consists of changing the cognitive infrastructure of delusions.

This study aims to evaluate the efficacy of the Portuguese version of the metacognitive training programme and its effects on psychotic symptoms, insight to the disorder and functionality

Full description

A randomized controlled trial that will be realized in six psychiatric institutions of Portugal. Pilot study will be carried out initially. The sample will be constituted by individuals diagnosed with schizophrenia (experimental group (n=30) and control group (n=30). The evaluation instruments will be utilized are PSYRATS, BCIS, PSP and WHODAS 2.0 applied to both groups in three different moments. In experimental group the eight MCT modules will be applied over four weeks.

The objective is to compare the outcomes associated with "treatment-as-usual" and the benefits of implementing the Metacognitive Training for Schizophrenia.

The hypothesis to be validated in this trial are:

• the schizophrenic patients who integrate the experimental group and participate in the MCT program will reduce the severity of psychotic symptoms and will present a better insight to disease and a better functioning on the final of the program than the control group;
• in participants that participating in the MCT program, the psychotic symptoms decrease at the end of the program and in the follow up (three months later) and the awareness for the disease and functioning improves.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age between 18 and 65 years;
• diagnosis of schizophrenia evaluated by Psychiatrist Assistant;
• that didn't have any changes in neuroleptics medication four months before program.

Exclusion criteria

• substance dependence;
• very severe psychotic symptoms that impedes understanding the objectives of the sessions;
• had changes in neuroleptics medication four months before program.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Experimental Group

Experimental group

Description:

Participants will be randomly allocated to either Metacognitive Training (MCT) (experimental group). In both groups will be maintained the "treatment as usual" (TAU).

Treatment:

Other: Treatment As Usual (TAU)

Behavioral: Metacognitive Training in Schizophrenia (MCT)

Control Group

Active Comparator group

Description:

The control group will not participate in the MCT program. In both groups will be maintained the TAU.

Treatment:

Other: Treatment As Usual (TAU)