Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of Metacognitive Training for Schizophrenia - a Study Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03891186
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : June 4, 2019
Sponsor:
Collaborator:
Center for Health Technology and Services Research
Information provided by (Responsible Party):
Carme Ferré Grau, 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


Condition or disease Intervention/treatment Phase
Schizophrenia Behavioral: Metacognitive Training in Schizophrenia (MCT) Other: Treatment As Usual (TAU) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Metacognitive Training For Schizophrenia
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: 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).
Primary Purpose: Supportive Care
Official Title: A Randomized Controlled Trial to Evaluate the Efficacy of Metacognitive Training for Schizophrenia Applied by Mental Health Nurses: Study Protocol
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: 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).
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.

Active Comparator: Control Group
The control group will not participate in the MCT program. In both groups will be maintained the TAU.
Other: Treatment As Usual (TAU)
In both groups will be maintained the TAU.




Primary Outcome Measures :
  1. Psychotic Symptom Rating Scales (PSYRATS) - moment 1 [ Time Frame: 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).

  2. Psychotic Symptom Rating Scales (PSYRATS) - moment 2 [ Time Frame: 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).

  3. Psychotic Symptom Rating Scales (PSYRATS) - moment 3 [ Time Frame: 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).

  4. Beck Cognitive Insight Scale (BCIS) - moment 1 [ Time Frame: 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)

  5. Beck Cognitive Insight Scale (BCIS) - moment 2 [ Time Frame: 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)

  6. Beck Cognitive Insight Scale (BCIS) - moment 3 [ Time Frame: 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)

  7. World Health Disability Assessment Schedule (WHODAS 2.0) - moment 1 [ Time Frame: 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).

  8. World Health Disability Assessment Schedule (WHODAS 2.0) - moment 2 [ Time Frame: 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).

  9. World Health Disability Assessment Schedule (WHODAS 2.0) - moment 3 [ Time Frame: 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).

  10. Personal and Social Performance Scale (PSP) - moment 1 [ Time Frame: 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).

  11. Personal and Social Performance Scale (PSP) - moment 2 [ Time Frame: 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).

  12. Personal and Social Performance Scale (PSP) - moment 3 [ Time Frame: 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).


Other Outcome Measures:
  1. Sociodemographic and clinical data [ Time Frame: Sociodemographic and clinical data will be applied a week before the first session of Metacognitive Training on both groups. ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03891186


Contacts
Layout table for location contacts
Contact: Lara Pinho, PhD 00351 928 065 867 larapinho7@gmail.com

Locations
Layout table for location information
Portugal
Lara Manuela Guedes de Pinho Not yet recruiting
Aveiro, Portugal, 3830-070
Contact: Lara Guedes de Pinho, PhD    00351916545031    larapinho7@gmail.com   
Principal Investigator: Lara Guedes de Pinho, PhD         
Sub-Investigator: Carlos Sequeira, PhD         
Sub-Investigator: Carme Grau, PhD         
Sub-Investigator: Francisco Sampaio, PhD         
Sub-Investigator: Nuno Rocha, PhD         
Lara Manuela Guedes de Pinho Recruiting
Aveiro, Portugal, 3830-070
Contact: Lara Guedes de Pinho, PhD    +351 916545031    larapinho7@gmail.com   
Sponsors and Collaborators
University Rovira i Virgili
Center for Health Technology and Services Research

Layout table for additonal information
Responsible Party: Carme Ferré Grau, Professor, University Rovira i Virgili
ClinicalTrials.gov Identifier: NCT03891186     History of Changes
Other Study ID Numbers: 2019MCT.PT
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carme Ferré Grau, University Rovira i Virgili:
schizophrenia
metacognitive training
insight
positive symptoms
functioning
Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders