SchizophreniaNCT03891186
Efficacy of Metacognitive Training for Schizophrenia - a Study Protocol
A study testing Metacognitive Training in Schizophrenia (MCT) and Treatment As Usual (TAU) in people with Schizophrenia, run by University Rovira i Virgili at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Metacognitive Training in Schizophrenia (MCT) and Treatment As Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePortugal
- Study dates
- 15 Apr 2019to 4 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- substance dependence;
- very severe psychotic symptoms that impedes understanding the objectives of the sessions;
- had changes in neuroleptics medication four months before program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial to Evaluate the Efficacy of Metacognitive Training for Schizophrenia Applied by Mental Health Nurses: Study Protocol
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
Read the 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
- Being tested
- Metacognitive Training in Schizophrenia (MCT), Treatment As Usual (TAU)
- Keywords
- schizophrenia, metacognitive training, insight, positive symptoms, functioning
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metacognitive Training in Schizophrenia (MCT)Behavioural
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).
In both groups will be maintained the TAU.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Treatment As Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: This instrument will be reapplied to follow up evaluation, up to 3 months after the final program in both groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start15 Apr 2019
- Primary completion4 Apr 2020
- Study completion4 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Metacognitive Training For Schizophrenia
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Rovira i Virgili
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Health Technology and Services Research
- Responsible party
- Principal investigator, Carme Ferré Grau, University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03891186
- Sponsor's protocol ID
- 2019MCT.PT
- Status last verified
- Apr 2020
- First submitted
- 5 Feb 2019
- Last updated
- 7 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33222210
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate the Efficacy of Metacognitive Training for Schizophrenia Applied by Mental Health Nurses: Study Protocol
- ClinicalTrials.gov ID
- NCT03891186
- Acronym / sponsor ID
- 2019MCT.PT
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, metacognitive training, insight, positive symptoms, functioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Rovira i VirgiliUniversity, hospital or other
- Collaborators
- Center for Health Technology and Services Research
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 4 Apr 2020 (actual)
- Study completion
- 4 Apr 2020 (actual)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Metacognitive Training For Schizophrenia
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Metacognitive Training in Schizophrenia (MCT), Other: 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). |
| Control Group | Active comparator | Other: Treatment As Usual (TAU)The control group will not participate in the MCT program. In both groups will be maintained the TAU. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- substance dependence;
- very severe psychotic symptoms that impedes understanding the objectives of the sessions;
- had changes in neuroleptics medication four months before program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Behavioural | Experimental Group |
| Treatment As Usual (TAU)In both groups will be maintained the TAU. | Other | Control Group, Experimental Group |
Primary outcome
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).
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).
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).
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)
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)
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)
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).
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).
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).
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).
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Derived from this study: PubMed 33222210de 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.
- Individual participant dataSharing planned: Undecided
Related trials for Schizophrenia
Recruiting
MI-CBTech: A Mobile Intervention for Community Integration in Homeless-Experienced Veterans With SMI
Schizophrenia Spectrum Disorders, Psychotic Affective Disorders
RecruitingObservational study
Tau Biomarkers in Late-onset Psychosis (LOP)
Late Onset Schizophrenia, Delusional Disorder (Late Onset)
Active, not recruitingObservational study
Profiling Vulnerability and Resilience for Mental Illness Following Viral Infections
Severe Mental Illness, Inflammation
RecruitingPhase 3
Sequential Treatment Approaches for Treatment-Resistant Schizophrenia
Treatment-resistant Schizophrenia
Recruiting
REACH Study (Recovery Environments: Assessing Cognitive & Brain Health in Community Mental Health)
Schizophrenia, Schizo Affective Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metacognitive Training in Schizophrenia (MCT) and Treatment As Usual (TAU) in people with Schizophrenia, run by University Rovira i Virgili at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychotic Symptom Rating Scales (PSYRATS) - moment 1 (time frame: PSYRATS will be applied a week before the first session of Metacognitive Training.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03891186, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.