Efficacy of Metacognitive Training for Schizophrenia - a Study Protocol
- Conditions
- Schizophrenia
- Interventions
- Behavioral: Metacognitive Training in Schizophrenia (MCT)Other: Treatment As Usual (TAU)
- Registration Number
- NCT03891186
- Lead Sponsor
- University Rovira i Virgili
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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.
- substance dependence;
- very severe psychotic symptoms that impedes understanding the objectives of the sessions;
- had changes in neuroleptics medication four months before program.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Group Metacognitive Training in Schizophrenia (MCT) Participants will be randomly allocated to either Metacognitive Training (MCT) (experimental group). In both groups will be maintained the "treatment as usual" (TAU). Control Group Treatment As Usual (TAU) The control group will not participate in the MCT program. In both groups will be maintained the TAU. Experimental Group Treatment As Usual (TAU) Participants will be randomly allocated to either Metacognitive Training (MCT) (experimental group). In both groups will be maintained the "treatment as usual" (TAU).
- Primary Outcome Measures
Name Time Method Psychotic Symptom Rating Scales (PSYRATS) - moment 2 PSYRATS will be applied up to 1 week after eight session, to both groups. 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).
Beck Cognitive Insight Scale (BCIS) - moment 3 This instrument will be reapplied to follow up evaluation, up to 3 months after the final program in both groups. 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)Psychotic Symptom Rating Scales (PSYRATS) - moment 1 PSYRATS will be applied a week before the first session of Metacognitive Training. 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).
Psychotic Symptom Rating Scales (PSYRATS) - moment 3 This instrument will be reapplied to follow up evaluation, up to 3 months after the final program, in both groups. 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).
Beck Cognitive Insight Scale (BCIS) - moment 1 BCIS will be applied a week before the first session of Metacognitive Training 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)Beck Cognitive Insight Scale (BCIS) - moment 2 BCIS will be applied up to 1 week after eight session of the MCT, to both groups 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)World Health Disability Assessment Schedule (WHODAS 2.0) - moment 1 WHODAS 2.0 will be applied a week before the first session of Metacognitive Training 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).
World Health Disability Assessment Schedule (WHODAS 2.0) - moment 2 WHODAS 2.0 will be applied up to 1 week after eight session of the MCT, to both groups 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).
Personal and Social Performance Scale (PSP) - moment 1 PSP will be applied a week before the first session of Metacognitive Training 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).
Personal and Social Performance Scale (PSP) - moment 2 PSP will be applied up to 1 week after eight session of the MCT, to both groups 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).
Personal and Social Performance Scale (PSP) - moment 3 This instrument will be reapplied to follow up evaluation, up to 3 months after the final program in both groups. 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).
World Health Disability Assessment Schedule (WHODAS 2.0) - moment 3 This instrument will be reapplied to follow up evaluation, up to 3 months after the final program in both groups. 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Lara Manuela Guedes de Pinho
🇵🇹Portalegre, Portugal