Efficacy of Metacognitive Training for Schizophrenia - a Study Protocol

Schizophrenia Clinical Trial

Official title:

A Randomized Controlled Trial to Evaluate the Efficacy of Metacognitive Training for Schizophrenia Applied by Mental Health Nurses: Study Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03891186
• Other study ID #: 2019MCT.PT
• Status: Completed
• Phase: N/A
• Start date: April 15, 2019
• Est. completion date: April 4, 2020

Study information

• Verified date: April 2020
• Source: University Rovira i Virgili
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 4, 2020
• Est. primary completion date: April 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• 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).

Other:
• Treatment As Usual (TAU)
In both groups will be maintained the TAU.

Locations

Country	Name	City	State
Portugal	Lara Manuela Guedes de Pinho	Portalegre

Sponsors (2)

Lead Sponsor	Collaborator
University Rovira i Virgili	Center for Health Technology and Services Research

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sociodemographic and clinical data	Age, gender (male (1) or female (2)), marital status (single (1), married (2), divorced (3), widower (4)), cohabitation (institution (1), alone (2), parents (3), mother or father (4), son (5), sibling (6), other family (7), other non-family (8)), educational level (illiterate (1), primary education (2), 6th grade (3), 9th grade (4), Secondary education (5), Bachelor (6), Master degree (7), PhD (8)), professional/employment status (employee (1), unemployed (2), disability (3), retired (4), medical leave (5)), duration of mental disorder (< 1 year (1), 1 to 2 years (2), 2 to 5 years (3), 5 to 10 years (4), 10 to 20 years (5), > 20 years ago (6)), number of Psychiatric hospitalizations (only once (1), 2 to 5 times (2), 6 to 10 times (3), more than 10 times (4)) and substance use (tobacco (1), alcohol (2), other drugs(3)). This data will be collected a week before be beginning program to all participants.	Sociodemographic and clinical data will be applied a week before the first session of Metacognitive Training on both groups.
Primary	Psychotic Symptom Rating Scales (PSYRATS) - moment 1	This instrument is a structured interview that assesses the detailed measurement of delusions and hallucinations. The PSYRATS have 17 items and two subscales: one subscale assesses delusions (6 items) and the other subscale assess hallucinations (11 items). Each item has a classification of five points (0-4). The total score is the sum of all points. It is was developed by Haddock, McCarron, Tarrier and Faragher in 1999 (validated for the Portuguese population by Telles-Correia et al in 2017).	PSYRATS will be applied a week before the first session of Metacognitive Training.
Primary	Psychotic Symptom Rating Scales (PSYRATS) - moment 2	This instrument is a structured interview that assesses the detailed measurement of delusions and hallucinations. The PSYRATS have 17 items and two subscales: one subscale assesses delusions (6 items) and the other subscale assess hallucinations (11 items). Each item has a classification of five points (0-4). The total score is the sum of all points. It is was developed by Haddock, McCarron, Tarrier and Faragher in 1999 (validated for the Portuguese population by Telles-Correia et al in 2017).	PSYRATS will be applied up to 1 week after eight session, to both groups.
Primary	Psychotic Symptom Rating Scales (PSYRATS) - moment 3	This instrument is a structured interview that assesses the detailed measurement of delusions and hallucinations. The PSYRATS have 17 items and two subscales: one subscale assesses delusions (6 items) and the other subscale assess hallucinations (11 items). Each item has a classification of five points (0-4). The total score is the sum of all points. It is was developed by Haddock, McCarron, Tarrier and Faragher in 1999 (validated for the Portuguese population by Telles-Correia et al in 2017).	This instrument will be reapplied to follow up evaluation, up to 3 months after the final program, in both groups.
Primary	Beck Cognitive Insight Scale (BCIS) - moment 1	This scale has 15 items and it is a self-response questionnaire that was developed by Beck, Baruch, Balter, Steer, & Warman in 2004 and evaluated the consciousness of the illness. The BCIS is comprised of two subscales: self-reflectiveness and self-certainty. The total score for each scale is the sum of the item scores that comprise it (see below). The BCIS composite index is calculated as self-reflectiveness minus self-certainty. Poorer cognitive insight is indexed by lower scores on the self-reflectiveness subscale, higher self-certainty scores, and lower BCIS composite index scores.; Step 1. Score every item on the BCIS from "0" to "3" according to the following rule: "Do Not Agree at All" = 0; "Agree Slightly" = 1; "Agree a Lot" = 2; "Agree Completely" = 3 (in process of validation to Portuguese population by investigators of this study)	BCIS will be applied a week before the first session of Metacognitive Training
Primary	Beck Cognitive Insight Scale (BCIS) - moment 2	This scale has 15 items and it is a self-response questionnaire that was developed by Beck, Baruch, Balter, Steer, & Warman in 2004 and evaluated the consciousness of the illness. The BCIS is comprised of two subscales: self-reflectiveness and self-certainty. The total score for each scale is the sum of the item scores that comprise it (see below). The BCIS composite index is calculated as self-reflectiveness minus self-certainty. Poorer cognitive insight is indexed by lower scores on the self-reflectiveness subscale, higher self-certainty scores, and lower BCIS composite index scores.; Step 1. Score every item on the BCIS from "0" to "3" according to the following rule: "Do Not Agree at All" = 0; "Agree Slightly" = 1; "Agree a Lot" = 2; "Agree Completely" = 3 (in process of validation to Portuguese population by investigators of this study)	BCIS will be applied up to 1 week after eight session of the MCT, to both groups
Primary	Beck Cognitive Insight Scale (BCIS) - moment 3	This scale has 15 items and it is a self-response questionnaire that was developed by Beck, Baruch, Balter, Steer, & Warman in 2004 and evaluated the consciousness of the illness. The BCIS is comprised of two subscales: self-reflectiveness and self-certainty. The total score for each scale is the sum of the item scores that comprise it (see below). The BCIS composite index is calculated as self-reflectiveness minus self-certainty. Poorer cognitive insight is indexed by lower scores on the self-reflectiveness subscale, higher self-certainty scores, and lower BCIS composite index scores.; Step 1. Score every item on the BCIS from "0" to "3" according to the following rule: "Do Not Agree at All" = 0; "Agree Slightly" = 1; "Agree a Lot" = 2; "Agree Completely" = 3 (in process of validation to Portuguese population by investigators of this study)	This instrument will be reapplied to follow up evaluation, up to 3 months after the final program in both groups.
Primary	World Health Disability Assessment Schedule (WHODAS 2.0) - moment 1	This instrument evaluated the functionality levels and was developed by WHO. It has 12 items and it is a self-response questionnaire (validated for the Portuguese population by Moreira, Alvarelhão, Silva, Costa and Queirós in 2015).	WHODAS 2.0 will be applied a week before the first session of Metacognitive Training
Primary	World Health Disability Assessment Schedule (WHODAS 2.0) - moment 2	This instrument evaluated the functionality levels and was developed by WHO. It has 12 items and it is a self-response questionnaire (validated for the Portuguese population by Moreira, Alvarelhão, Silva, Costa and Queirós in 2015).	WHODAS 2.0 will be applied up to 1 week after eight session of the MCT, to both groups
Primary	World Health Disability Assessment Schedule (WHODAS 2.0) - moment 3	This instrument evaluated the functionality levels and was developed by WHO. It has 12 items and it is a self-response questionnaire (validated for the Portuguese population by Moreira, Alvarelhão, Silva, Costa and Queirós in 2015).	This instrument will be reapplied to follow up evaluation, up to 3 months after the final program in both groups.
Primary	Personal and Social Performance Scale (PSP) - moment 1	this scale was developed by Morosini, Magliano, Brambilla, Ugolini and Pioli in 2000 and it assesses patients' social functioning with four main areas: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behaviours (validated for the Portuguese population by Brissos et al., 2012).	PSP will be applied a week before the first session of Metacognitive Training
Primary	Personal and Social Performance Scale (PSP) - moment 2	this scale was developed by Morosini, Magliano, Brambilla, Ugolini and Pioli in 2000 and it assesses patients' social functioning with four main areas: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behaviours (validated for the Portuguese population by Brissos et al., 2012).	PSP will be applied up to 1 week after eight session of the MCT, to both groups
Primary	Personal and Social Performance Scale (PSP) - moment 3	this scale was developed by Morosini, Magliano, Brambilla, Ugolini and Pioli in 2000 and it assesses patients' social functioning with four main areas: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behaviours (validated for the Portuguese population by Brissos et al., 2012).	This instrument will be reapplied to follow up evaluation, up to 3 months after the final program in both groups.