Clinical trial NCT03891186: Efficacy of Metacognitive Training for Schizophrenia - a Study Protocol
Official title: A Randomized Controlled Trial to Evaluate the Efficacy of Metacognitive Training for Schizophrenia Applied by Mental Health Nurses: Study Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: schizophrenia
metacognitive training
insight
positive symptoms
functioning
Lead sponsor: University Rovira i Virgili
Sponsor class: OTHER
Collaborators: name: Center for Health Technology and Services Research
First posted: 2019-03-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Metacognitive Training For Schizophrenia
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Psychotic Symptom Rating Scales (PSYRATS) - moment 1
timeFrame: PSYRATS will be applied a week before the first session of Metacognitive Training.
measure: Psychotic Symptom Rating Scales (PSYRATS) - moment 2
timeFrame: PSYRATS will be applied up to 1 week after eight session, to both groups.
measure: Psychotic Symptom Rating Scales (PSYRATS) - moment 3
timeFrame: This instrument will be reapplied to follow up evaluation, up to 3 months after the final program, in both groups.
measure: Beck Cognitive Insight Scale (BCIS) - moment 1
timeFrame: BCIS will be applied a week before the first session of Metacognitive Training
measure: Beck Cognitive Insight Scale (BCIS) - moment 2
timeFrame: BCIS will be applied up to 1 week after eight session of the MCT, to both groups
measure: Beck Cognitive Insight Scale (BCIS) - moment 3
timeFrame: This instrument will be reapplied to follow up evaluation, up to 3 months after the final program in both groups.
measure: World Health Disability Assessment Schedule (WHODAS 2.0) - moment 1
timeFrame: WHODAS 2.0 will be applied a week before the first session of Metacognitive Training
measure: World Health Disability Assessment Schedule (WHODAS 2.0) - moment 2
timeFrame: WHODAS 2.0 will be applied up to 1 week after eight session of the MCT, to both groups
measure: World Health Disability Assessment Schedule (WHODAS 2.0) - moment 3
timeFrame: This instrument will be reapplied to follow up evaluation, up to 3 months after the final program in both groups.
measure: Personal and Social Performance Scale (PSP) - moment 1
timeFrame: PSP will be applied a week before the first session of Metacognitive Training
measure: Personal and Social Performance Scale (PSP) - moment 2
timeFrame: PSP will be applied up to 1 week after eight session of the MCT, to both groups
measure: Personal and Social Performance Scale (PSP) - moment 3
timeFrame: This instrument will be reapplied to follow up evaluation, up to 3 months after the final program in both groups.
Secondary outcomes:
Other outcomes:
measure: Sociodemographic and clinical data
timeFrame: Sociodemographic and clinical data will be applied a week before the first session of Metacognitive Training on both groups.
Locations:
city: Portalegre
country: Portugal
facility: Lara Manuela Guedes de Pinho
Study officials:
References:
citation: 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.