Mindfulness-based social cognition training (SocialMIND) versus psychoeducational multicomponent intervention for people with a first episode of psychosis: a study protocol for a randomised controlled trial. 2019

Roberto Mediavilla, and Ainoa Muñoz-Sanjose, and Beatriz Rodriguez-Vega, and Carmen Bayon, and Angela Palao, and Guillermo Lahera, and Pilar Sanchez-Castro, and Eva Roman, and Susana Cebolla, and Alvaro de Diego, and Juan Manuel Pastor, and Maria Fe Bravo-Ortiz
Psychiatry and Mental Health Group, Hospital La Paz Institute for Health Research (IdiPAZ), Madrid, Spain. roberto.mediavilla@idipaz.es.

People who suffer a first episode of psychosis experience higher levels of distress and suffering. Early intervention programs combine pharmacological and psychosocial strategies that include different components, such as cognitive-behavioural therapy, psychosocial interventions, medication adherence, family psychoeducation, counselling, etc. Among the complementary approaches, mindfulness-based interventions help participants to cultivate a radical acceptance of their psychotic experiences within a person-centered framework. They show promising results for people with longer duration of psychosis, but there is still no evidence for people who have recently experienced their first episode of psychosis. The present parallel-group, single-blind (evaluator), randomised (1:1 ratio), controlled (versus active comparator), superiority, clinical trial will compare the effectiveness of SocialMIND on social functioning as measured by the Personal and Social Performance (PSP) scale. The active comparator will be a psychoeducational multicomponent intervention (PMI) that incorporates elements of early intervention programs that are effective for people who have suffered a first episode of psychosis. Both SocialMIND and PMI encompass eight weekly sessions, four bi-weekly sessions, and five monthly sessions. Changes in primary and secondary outcomes will be measured after weekly (8th week), bi-weekly (16th week) and monthly sessions (56th week), and 3 months after completing the intervention (68th week). Secondary outcomes include symptoms of psychosis, anxiety and depression, as well as indicators of general functioning. Tertiary outcomes are measures of social cognition, neurocognition, mindfulness, and indicators of inflammation and oxidative stress. A final sample of 80 participants is proposed to detect clinically significant differences in social functioning. This is the first mindfulness-based social cognition training for people with psychosis. SocialMIND aims to generate changes in the real-life functioning of people who have experienced a first episode of psychosis, and to be at least as effective as a psychoeducational multicomponent program. Adherence to the interventions is a common problem among young people with psychosis, so several difficulties are anticipated, and some methodological issues are discussed. The trial was registered in ClinicalTrials.gov in October 2018 (NCT03309475).

UI MeSH Term Description Entries
D008297 Male Males
D010353 Patient Education as Topic The teaching or training of patients concerning their own health needs. Education of Patients,Education, Patient,Patient Education
D011613 Psychotherapy A generic term for the treatment of mental illness or emotional disturbances primarily by verbal or nonverbal communication. Psychotherapies
D011618 Psychotic Disorders Disorders in which there is a loss of ego boundaries or a gross impairment in reality testing with delusions or prominent hallucinations. (From DSM-IV, 1994) Psychoses,Psychosis, Brief Reactive,Schizoaffective Disorder,Schizophreniform Disorders,Psychosis,Brief Reactive Psychoses,Brief Reactive Psychosis,Disorder, Psychotic,Disorder, Schizoaffective,Disorder, Schizophreniform,Disorders, Psychotic,Disorders, Schizoaffective,Disorders, Schizophreniform,Psychoses, Brief Reactive,Psychotic Disorder,Reactive Psychoses, Brief,Reactive Psychosis, Brief,Schizoaffective Disorders,Schizophreniform Disorder
D003071 Cognition Intellectual or mental process whereby an organism obtains knowledge. Cognitive Function,Cognitions,Cognitive Functions,Function, Cognitive,Functions, Cognitive
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000074099 Equivalence Trials as Topic Works about trials that aim to show a new treatment is no better and no worse than the standard treatment. Non-Inferiority Trials as Topic,NonInferiority Trials as Topic,Superiority Trial as Topic,Non Inferiority Trials as Topic
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults
D012919 Social Behavior Any behavior caused by or affecting another individual or group usually of the same species. Sociality,Behavior, Social,Behaviors, Social,Social Behaviors

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