Effectiveness of a Mindfulness-based Group Training Addressing Social Cognition in First Episode Psychosis (AGES-Mind)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mindfulness-based Social Cognition Group Training (SocialMIND) Versus Psychoeducational Multicomponent Intervention in Patients With a First Episode of Psychosis (AGES-Mind Study): A Randomized Controlled Trial

Conditions
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Schizophrenia and Disorders With Psychotic Features, Psychotic Episode

Intervention / Treatment
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* Behavioral: SocialMIND
* Behavioral: Psychoeducational multicomponent intervention
* Behavioral: Psychosocial treatment
* Drug: Psychotropic treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-45 years old First hospitalization, first visit to mental health services with positive symptoms, onset of antipsychotic treatment, or first appearance of positive symptoms confirmed by an informant within the period of five years prior to the enrolment in the study; Informed consent given Exclusion Criteria: Clinical Global Impression (CGI) higher than 5 (markedly ill) Other Axis I diagnoses, except for substance use if psychotic symptoms remain at least 14 days after negative urine test. Intellectual disability plus impaired global functioning prior to disorder onset Generalized development disorder Pregnancy Attendance to either mindfulness programs or structured psychoeducational interventions at the time of the enrolment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SocialMIND<br>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<br>* 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.<br>* Other names: MB-SCT;Behavioral: Psychosocial treatment<br>* Treatment as usual delivered by patient's practitioner<br>Drug: Psychotropic treatment<br>* Treatment as usual delivered by patient's practitioner<br>* Other names: Drug treatment;|
| Active Comparator: Psychoeducational Multicomponent Intervention<br>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<br>* 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.<br>* Other names: Psychoeducation group;Behavioral: Psychosocial treatment<br>* Treatment as usual delivered by patient's practitioner<br>Drug: Psychotropic treatment<br>* Treatment as usual delivered by patient's practitioner<br>* Other names: Drug treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8, 16, 36 and 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in global functioning | Global Assessment of Functioning Scale (GAF) measures patient's general functioning using a single 0-100 scale. | 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. | 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 | 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. | 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 | 8, 16, 36 and 48 weeks | 
| Change in anxiety symptoms | Beck Anxiety Inventory (BAI) measures clinical anxiety through 21 items. | 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. | 8, 16, 36 and 48 weeks | 
| Change in reflective functioning | Reflective Functioning Questionnaire (RFQ-8) measures mentalization ability through a set of 8 questions | 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. | 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. | 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 | 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) | 8, 16, 36 and 48 weeks | 
| Change in oxidative stress and anti-inflammatory response | Total antioxidant status, enzymatic activity and cytokines | 8 and 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AGES-Mind, first episode psychosis, early psychosis, schizophrenia, mindfulness, social cognition, social functioning, SocialMind