An interventional study of SocialMIND and Psychoeducational multicomponent intervention in Schizophrenia and Disorders With Psychotic Features and Psychotic Episode, sponsored by Instituto de Investigación Hospital Universitario La Paz. Completed at 1 site in Spain. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-01-09.
Sponsored by Instituto de Investigación Hospital Universitario La Paz · Not applicable, Interventional, and Treatment
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.
84 studies on the registry are indexed under Schizophrenia Spectrum and Other Psychotic Disorders; 14 are open to participants now.
This study's enrollment of 59 is below the median of 90 across 67 interventional studies indexed under Schizophrenia Spectrum and Other Psychotic Disorders.
Browse Schizophrenia Spectrum and Other Psychotic Disorders studies →Instituto de Investigación Hospital Universitario La Paz is the lead sponsor of 104 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The experimental arm will receive treatment as usual (both psychotropic treatment and psychosocial treatment) and mindfulness-based social cognition group training (SocialMind), specifically designed for patients with first episode psychosis by the research team. There will be a first phase (intensive intervention) consisting of 8 weekly sessions and a second phase (follow-up sessions) consisting of 4 fortnightly sessions and 5 monthly sessions.
Behavioral: SocialMIND · Behavioral: Psychosocial treatment · Drug: Psychotropic treatment
The active comparator arm will receive treatment as usual (both psychotropic treatment and psychosocial treatment) and a psychoeducational multicomponent intervention for psychosis.There will be a first phase (intensive intervention) consisting of 8 weekly sessions and a second phase (follow-up sessions) consisting of 4 fortnightly sessions and 7 monthly sessions.
Behavioral: Psychoeducational multicomponent intervention · Behavioral: Psychosocial treatment · Drug: Psychotropic treatment
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.
Also known as: Mindfulness-based social cognition training, Mindfulness-based social cognition group training, MB-SCT
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.
Also known as: PMI, Structured psychoeducational group, Psychoeducational group, Psychoeducation group
Treatment as usual delivered by patient's practitioner
Treatment as usual delivered by patient's practitioner
Also known as: Drug treatment
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
Plan to share: Yes — Individual participant data will be available on request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: The data will be available after the final results are published and for ever
Access criteria: Researchers that are interested should contact the Principal Investigator
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Schizophrenia Spectrum and Other Psychotic Disorders →
Instituto de Investigación Hospital Universitario La Paz →