Study protocol of a randomised clinical trial testing whether metacognitive training can improve insight and clinical outcomes in schizophrenia

Autor: Javier-David Lopez-Morinigo, Enrique Baca-García, Laura Mata-Iturralde, Laura Muñoz-Lorenzo, Anthony S. David, Sergio Sánchez-Alonso, Verónica González Ruiz-Ruano, María Luisa Barrigón Estévez, Antonio Artés-Rodríguez, Adela Sánchez Escribano Martínez
Přispěvatelé: UAM. Departamento de Psiquiatría, Instituto de Investigación Sanitaria Fundación Jiménez Díaz (IIS-FJD), Comunidad de Madrid, European Commission, Instituto de Investigación Sanitaria Fundación Jiménez Díaz (ISS-FJD)
Rok vydání: 2020
Předmět:
Adult
Male
medicine.medical_specialty
Adolescent
lcsh:RC435-571
Medicina
medicine.medical_treatment
Metacognitive training
Metacognition
Schizophrenia spectrum disorders
Support group
law.invention
Schizophrenia spectrum disorders (SSD)
03 medical and health sciences
Study Protocol
Young Adult
0302 clinical medicine
Randomized controlled trial
law
lcsh:Psychiatry
medicine
Humans
Clinical significance
Single-Blind Method
Child
Ecological momentary assessment
Biología y Biomedicina
Protocol (science)
Cognitive Behavioral Therapy
business.industry
Cognition
Middle Aged
medicine.disease
030227 psychiatry
3. Good health
Clinical trial
Psychiatry and Mental health
Treatment Outcome
Schizophrenia
Physical therapy
Female
Schizophrenic Psychology
business
Insight
030217 neurology & neurosurgery
Follow-Up Studies
Zdroj: BMC Psychiatry
Biblos-e Archivo. Repositorio Institucional de la UAM
instname
e-Archivo. Repositorio Institucional de la Universidad Carlos III de Madrid
BMC Psychiatry, Vol 20, Iss 1, Pp 1-11 (2020)
Biblos-e Archivo: Repositorio Institucional de la UAM
Universidad Autónoma de Madrid
ISSN: 1471-244X
DOI: 10.1186/s12888-020-2431-x
Popis: Background: Although insight in schizophrenia spectrum disorders (SSD) has been associated with positive outcomes, the effect size of previous treatments on insight has been relatively small to date. The metacognitive basis of insight suggests that metacognitive training (MCT) may improve insight and clinical outcomes in SSD, although this remains to be established. Methods: This single-center, assessor-blind, parallel-group, randomised clinical trial (RCT) aims to investigate the efficacy of MCT for improving insight (primary outcome), including clinical and cognitive insight, which will be measured by the Schedule for Assessment of Insight (Expanded version) (SAI-E) and the Beck Cognitive Scale (BCIS), respectively, in (at least) n = 126 outpatients with SSD at three points in time: i) at baseline (T0); ii) after treatment (T1) and iii) at 1-year follow-up (T2). SSD patients receiving MCT and controls attending a non-intervention support group will be compared on insight level changes and several clinical and cognitive secondary outcomes at T1 and T2, whilst adjusting for baseline data. Ecological momentary assessment (EMA) will be piloted to assess functioning in a subsample of participants. Discussion: To the best of our knowledge, this will be the first RCT testing the effect of group MCT on multiple insight dimensions (as primary outcome) in a sample of unselected patients with SSD, including several secondary outcomes of clinical relevance, namely symptom severity, functioning, which will also be evaluated with EMA, hospitalizations and suicidal behaviour.
This study was supported by the Universidad Autónoma de Madrid and European Union via the Intertalentum Project Grant-Marie Skłodowska Curie Actions (GA 713366) to JDLM who is the Princiapl Investigator. This grant therefore funds both JDLM’s salary and the consumable expenses related to the study. JDLM, VGRR, ASEM, MLBE, LMI, LML, SSA, AAR and EBG’s salaries come from the Hospital Universitario Fundación Jiménez Díaz, where this study is currently being carried out, which therefore provides the necessary institutional/departmental support for its development. Additional departmental support concerning the use of Ecological Momentary Assessment (see Methods section, page 11 -last paragraph- and page 12 –first paragraph-, for details) is provided by the Instituto de Salud Carlos III (Madrid, Spain) (ISCIII PI16/01852) and the Madrid Regional Government (Madrid, Spain) (B2017/BMD-3740 AGES-CM 2CM; Y2018/TCS-4705 PRACTICO-CM). ASD acknowledges funding supports from University College London, which covers his salary
Databáze: OpenAIRE
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