Efficacy of Metacognitive Training for Schizophrenia - a Study Protocol

NCT03891186 | Completed

• 1 other identifier: 2019MCT.PT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Schizophrenia

Keywords

schizophrenia; metacognitive training; insight; positive symptoms; functioning

Outcome Measures

Primary Outcomes (12)

• 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.

• 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.

• 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.

• 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

• 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

• 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.

• 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

• 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

• 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.

• 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

• 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

• 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.

Other Outcomes (1)

• Sociodemographic and clinical data

  Sociodemographic and clinical data will be applied a week before the first session of Metacognitive Training on both groups.

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

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

Control Group

ACTIVE COMPARATOR

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

Other: Treatment As Usual (TAU)

Interventions

Metacognitive Training in Schizophrenia (MCT) 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).

Experimental Group

Treatment As Usual (TAU) OTHER

In both groups will be maintained the TAU.

Control Group; Experimental Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Rovira i Virgili: lead
• Center for Health Technology and Services Research: collaborator

Study Sites (1)

Lara Manuela Guedes de Pinho

Portalegre, 7300-004, Portugal

Location

Related Publications (1)

• 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.

  PMID: 33222210 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Eligible participants will be recruited by the investigators in collaboration with the multidisciplinary team of each institution. A baseline assessment will be carried out and the instruments will be applied after informed consent by participants. Participants will be randomly allocated to either Metacognitive Training (MCT) (experimental group). The control group will not participate in the MCT program. In both groups will be maintained the TAU. The variables for whom the participants are stratified are educational level, duration of mental disorder and type of treatment. All participants will be re-assessed at the end of the program and three months later. The program will be applied during four weeks (two session per week).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Metacognitive Training For Schizophrenia

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: March 26, 2019
• Study Start: April 15, 2019
• Primary Completion: April 4, 2020
• Study Completion: April 4, 2020
• Last Updated: April 7, 2020

Record last verified: 2020-04

Locations

PT (1)