Effectiveness of a Mindfulness-based Group Training Addressing Social Cognition in First Episode Psychosis (AGES-Mind)
Condition: Schizophrenia and Disorders With Psychotic Features; Psychotic Episode
MeSH terms: Schizophrenia; Psychotic Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders
Study type: Interventional

Summary: 
      The current investigation aims to compare two group intervention in patients with a first
      episode of psychosis, that is, people who have suffered their first psychotic episode within
      5 years prior to their inclusion in the study. The experimental arm is a mindfulness-based
      social cognition training (SocialMind) designed by professionals with both formal training
      and clinical experience in the field of mindfulness and third generation cognitive-behavioral
      therapies. The active comparator arm is a psychoeducation program specifically designed for
      individuals with recent onset psychosis by members of the team with great experience in
      delivering such interventions. The main outcome is social functioning, as measured by the
      Personal and Social Performance Scale (PSP), an instrument developed for psychotic patients.
      The main hypothesis is that the improvement in social functioning will be larger among the
      participants on the experimental arm, because there is enough evidence suggesting that
      deficits in social cognition are present even in the first stages of psychotic syndrome and
      related to social functioning and general disability. Moreover, mindfulness-based
      interventions have proven themselves effective in other severe mental disorders.
    

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. Investigators' main hypothesis is that
      a mindfulness-based social cognition group training (SocialMind) will improve social and
      general functioning, and that this improvement will be higher in the SocialMind than in the
      psychoeducation group. Given the association between oxidative stress and cognitive
      functioning, a relationship between oxidative stress biomarkers and intervention-related
      variables is also expected.

      A research team with more than ten mental health professionals and many collaborators will
      carry and oversee the assessment sessions. A Pharmacology Department will analyse the
      biological samples. Regulated-trained, well-experienced clinicians will design and administer
      both interventions. The whole team will take part in the process of scientific publication
      and results dissemination.
    

Intervention name(s): SocialMIND; Psychoeducational multicomponent intervention; Psychosocial treatment; Psychotropic treatment
Intervention type(s): Behavioral; 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.; The psychoeducational multicomponent intervention addresses and discuss several aspects of great importance for persons who suffer a first episode of psychosis, such as biased perception and thinking, delusions-related anxiety or the nature of hallucinations. Its aim is to encourage patients to reflect upon their experiences from a critic perspective.; 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; PMI; Structured psychoeducational group; Psychoeducational group; Psychoeducation group; Drug treatment
Intervention MeSH terms: Psychotropic Drugs
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Pilot, multi-center, rater-blinded, prospective (48-weeks follow-up), randomized, controlled (versus active comparator [psychoeducation]), clinical trial. The experimental arm will receive treatment as usual (both drug and psychosocial therapy) and mindfulness-based social cognition group training, specifically designed for patients with first episode psychosis by the research team. The active comparator arm will receive treatment as usual (both drug and psychosocial therapy) and psychoeducation group training for psychosis.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: first episode psychosis; early psychosis; schizophrenia; mindfulness; social cognition; social functioning; AGES-Mind; SocialMind