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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03309475
Acronym
AGES-Mind
Enrollment
59
Registered
2017-10-13
Start date
2018-09-01
Completion date
2023-01-31
Last updated
2024-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia and Disorders With Psychotic Features, Psychotic Episode

Keywords

first episode psychosis, early psychosis, schizophrenia, mindfulness, social cognition, social functioning, AGES-Mind, SocialMind

Brief 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.

Interventions

BEHAVIORALSocialMIND

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.

BEHAVIORALPsychoeducational multicomponent intervention

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

Sponsors

Carlos III Health Institute
CollaboratorOTHER_GOV
European Regional Development Fund
CollaboratorOTHER
Instituto de Investigación Hospital Universitario La Paz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

The evaluators will not know the patients' assigned treatment arm until the end of the follow-up period. This information will only be delivered to investigators in charge of intervention groups, but not to those in charge of statistical analyses.

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in social functioning8, 16, 36 and 48 weeksPersonal and Social Performance Scale (PSP) measures patient's functioning on different social areas, such as self-care, relationships, social activities and aggressive behavior.

Secondary

MeasureTime frameDescription
Change in global functioning8, 16, 36 and 48 weeksGlobal Assessment of Functioning Scale (GAF) measures patient's general functioning using a single 0-100 scale.
Change in quality of life8, 16, 36 and 48 weeksWHOQOL-BREF measures patient's quality of life according to World Health Organization parameters.
Change in clinical global impression8, 16, 36 and 48 weeksClinical Global Impression Scale for Schizophrenia (CGI-SCH) measures patients' clinical state and clinical change over time
Change in psychotic symptoms8, 16, 36 and 48 weeksPositive and Negative Symptoms Scale for Schizophrenia (PANSS) measures psychotic syndrome through a detailed clinical interview.
Change in depressive symptoms8, 16, 36 and 48 weeksCalgary Depression Scale for Schizophrenia (CDSS) measures depressive symptoms in psychotic patients through a personal interview
Change in anxiety symptoms8, 16, 36 and 48 weeksBeck Anxiety Inventory (BAI) measures clinical anxiety through 21 items.
Change in oxidative stress and anti-inflammatory response8 and 48 weeksTotal antioxidant status, enzymatic activity and cytokines
Change in reflective functioning8, 16, 36 and 48 weeksReflective Functioning Questionnaire (RFQ-8) measures mentalization ability through a set of 8 questions
Change in emotional intelligence8, 16, 36 and 48 weeksMayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT v2.0) measures emotional intelligence through a set of questions referred to different situations.
Change in mindful attention and awareness8, 16, 36 and 48 weeksMindfulness Attention Awareness Scale (MAAS) measures processes thought to be related to clinical outcomes in mindfulness-based interventions.
Change in cognitive insight8, 16, 36 and 48 weeksBeck Cognitive Insight Scale (BCIS) explores self-reflection and self-certainty, as parts of the cognitive insight construct
Change in neurocognition8, 16, 36 and 48 weeksFour tasks of the Matrics Consensus Cognitive Battery (MCCB) measure different domains of neurocognition (symbol coding, letter number span, spatial span and CPT-IP)
Change in social cognition8, 16, 36 and 48 weeksHinting 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026