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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
59
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
La Paz University Hospital
Madrid, Spain
Change in social functioning
Personal and Social Performance Scale (PSP) measures patient's functioning on different social areas, such as self-care, relationships, social activities and aggressive behavior.
Time frame: 8, 16, 36 and 48 weeks
Change in global functioning
Global Assessment of Functioning Scale (GAF) measures patient's general functioning using a single 0-100 scale.
Time frame: 8, 16, 36 and 48 weeks
Change in quality of life
WHOQOL-BREF measures patient's quality of life according to World Health Organization parameters.
Time frame: 8, 16, 36 and 48 weeks
Change in clinical global impression
Clinical Global Impression Scale for Schizophrenia (CGI-SCH) measures patients' clinical state and clinical change over time
Time frame: 8, 16, 36 and 48 weeks
Change in psychotic symptoms
Positive and Negative Symptoms Scale for Schizophrenia (PANSS) measures psychotic syndrome through a detailed clinical interview.
Time frame: 8, 16, 36 and 48 weeks
Change in depressive symptoms
Calgary Depression Scale for Schizophrenia (CDSS) measures depressive symptoms in psychotic patients through a personal interview
Time frame: 8, 16, 36 and 48 weeks
Change in anxiety symptoms
Beck Anxiety Inventory (BAI) measures clinical anxiety through 21 items.
Time frame: 8, 16, 36 and 48 weeks
Change in social cognition
Hinting task, Reading the Mind in the Eyes Test (RMET), Emotion Recognition task (ER-40) and Ambiguous Intentions and Attribution Questionnaire (AIHQ) measure main domains of social cognition.
Time frame: 8, 16, 36 and 48 weeks
Change in reflective functioning
Reflective Functioning Questionnaire (RFQ-8) measures mentalization ability through a set of 8 questions
Time frame: 8, 16, 36 and 48 weeks
Change in emotional intelligence
Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT v2.0) measures emotional intelligence through a set of questions referred to different situations.
Time frame: 8, 16, 36 and 48 weeks
Change in mindful attention and awareness
Mindfulness Attention Awareness Scale (MAAS) measures processes thought to be related to clinical outcomes in mindfulness-based interventions.
Time frame: 8, 16, 36 and 48 weeks
Change in cognitive insight
Beck Cognitive Insight Scale (BCIS) explores self-reflection and self-certainty, as parts of the cognitive insight construct
Time frame: 8, 16, 36 and 48 weeks
Change in neurocognition
Four tasks of the Matrics Consensus Cognitive Battery (MCCB) measure different domains of neurocognition (symbol coding, letter number span, spatial span and CPT-IP)
Time frame: 8, 16, 36 and 48 weeks
Change in oxidative stress and anti-inflammatory response
Total antioxidant status, enzymatic activity and cytokines
Time frame: 8 and 48 weeks
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