Efficacy of Metacognitive Training for Schizophrenia - a Study Protocol

NCT ID: NCT03891186

Last Updated: 2020-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-15
• Study Completion Date: 2020-04-04

Brief Summary

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

Detailed 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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Experimental Group

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

Group Type: EXPERIMENTAL

Metacognitive Training in Schizophrenia (MCT)

Intervention Type: BEHAVIORAL

MCT is a group program with eight modules referring to common cognitive and biases in solving problems in schizophrenia. The following topics of MCT are: attribution blaming and taking credit (module 1), jumping to conclusions (modules 2 and 7), changing beliefs (module 3), deficits in theory of mind and social cognition (modules 4 and 6), overconfidence in (memory) errors (module 5) and depression and low self-esteem (module 8). Each session lasts 45 to 60 minutes and follows a protocol defined in the manual "Metacognitive Training for Psychosis (MCT)" that is currently available in 35 languages (available in www.uke.de/mkt).

Treatment As Usual (TAU)

Intervention Type: OTHER

In both groups will be maintained the TAU.

Control Group

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

Group Type: ACTIVE_COMPARATOR

Treatment As Usual (TAU)

Intervention Type: OTHER

In both groups will be maintained the TAU.

Interventions

Metacognitive Training in Schizophrenia (MCT)

MCT is a group program with eight modules referring to common cognitive and biases in solving problems in schizophrenia. The following topics of MCT are: attribution blaming and taking credit (module 1), jumping to conclusions (modules 2 and 7), changing beliefs (module 3), deficits in theory of mind and social cognition (modules 4 and 6), overconfidence in (memory) errors (module 5) and depression and low self-esteem (module 8). Each session lasts 45 to 60 minutes and follows a protocol defined in the manual "Metacognitive Training for Psychosis (MCT)" that is currently available in 35 languages (available in www.uke.de/mkt).

Intervention Type: BEHAVIORAL

Treatment As Usual (TAU)

In both groups will be maintained the TAU.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Center for Health Technology and Services Research

OTHER

Sponsor Role: collaborator

University Rovira i Virgili

OTHER

Sponsor Role: lead

Responsible Party

Carme Ferré Grau

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lara Manuela Guedes de Pinho

Portalegre, , Portugal

Countries

Portugal

References

de Pinho LMG, Sequeira CADC, Sampaio FMC, Rocha NB, Ozaslan Z, Ferre-Grau C. Assessing the efficacy and feasibility of providing metacognitive training for patients with schizophrenia by mental health nurses: A randomized controlled trial. J Adv Nurs. 2021 Feb;77(2):999-1012. doi: 10.1111/jan.14627. Epub 2020 Nov 22.

Reference Type: DERIVED

PMID: 33222210 (View on PubMed)

Other Identifiers

2019MCT.PT

Identifier Type: -

Identifier Source: org_study_id