Mindfulness-based Social Cognition Training for Psychosis (SocialMind): A Feasibility Study
Condition: Schizophrenia and Disorders With Psychotic Feature; Psychotic Episode
MeSH terms: Schizophrenia; Mental Disorders; Psychotic Disorders; Schizophrenia Spectrum and Other Psychotic Disorders
Study type: Interventional

Summary: 
      The current investigation has been designed to test the feasibility of a mindfulness-based
      social cognition training (SocialMind) for people with a first episode of psychosis
      (AGES-Mind Study, NCT03309475). The intervention has been designed by professionals with both
      formal training and clinical experience in the field of mindfulness and third generation
      cognitive-behavioral therapies. Main outcomes are recruitment rate, adverse events and
      treatment adherence, although therapy effects and adjustment to intervention manual are also
      explored.
    

Detailed description: 
      Social functioning is impaired among many patients with a first episode of psychosis, who
      also show a lower ability to recognize, understand and benefit from social stimuli (i.e.,
      deficits in social cognition) than their pairs. Both deficits underlie the general functional
      impairment found across non-affective psychotic syndromes. Since currently available
      pharmacological strategies have not proven themselves effective in addressing this matter,
      new psychotherapeutic approaches should be developed. This research team developed a
      mindfulness-based social cognition group training (SocialMind) designed for persons who have
      suffered a first episode of psychosis within five years prior to their enrollment in the
      study (AGES-Mind Study, NCT03309475). Although there is enough evidence to support the lack
      of adverse events derived for mindfulness-based interventions specifically designed for
      psychotic patients (Cramer et al., 2016), many clinicians express their concerns about the
      beneficial effects of these approaches. Therefore, and in keeping with international health
      organisms such as United Kingdom's National Health Service (NHS), this team have proposed a
      feasibility study. The main hypothesis is that the AGES-Mind study can be carried out in
      terms of achievement of recruitment rate, lack of adverse events and levels of treatment
      adherence. Secondary hypothesis states that clinicians will adhere to SocialMind manual.
      Finally, a positive effect of the intervention is expected, both in participants'
      satisfaction and in some relevant variables, such as functional outcomes, clinical global
      impression and social cognition.
    

Intervention name(s): SocialMind; Psychosocial treatment; Psychotropic treatment
Intervention type(s): Behavioral; Behavioral; Drug
Intervention description(s): SocialMind is a mindfulness-based intervention including elements such as radical acceptance, decentering or meditation-techniques. It is designed to target social cognition, defined as the ability to recognize, understand and benefit from social stimuli.; Treatment as usual delivered by patient's practitioner; Treatment as usual delivered by patient's practitioner
Other intervention name(s): Mindfulness-based social cognition training; Mindfulness-based social cognition group training; MB-SCT
Intervention MeSH terms: Psychotropic Drugs
Intervention model: Single Group Assignment
Intervention model description: Multi-center, open-label, prospective, non-randomized, single-group, clinical trial. The experimental arm will receive TAU (both drug and psychosocial therapy) and mindfulness-based social cognition group training (SocialMind), specifically designed for patients with first episode psychosis by the research team.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: schizophrenia; mindfulness; social cognition; SocialMind; AGES-Mind