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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2023-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Mindfulness-based Social Cognition Training for Psychosis (SocialMind): A Feasibility Study

NCT03434405

Schizophrenia and Disorders With Psychotic Feature Psychotic Episode

COMPLETED NA

Mindfulness-based Group Therapy for Inpatients With Schizophrenia Spectrum Disorders

NCT03671005

Psychotic Disorder

TERMINATED NA

Psychological Intervention for Persons in the Early Initial Prodromal State

NCT00204087

Schizophrenia Psychosis

UNKNOWN PHASE3

Mindfulness Intervention for People With Psychosis

NCT03501862

Recent-onset Psychosis

COMPLETED NA

Attention Shaping Procedures for Improving Psychosocial Skills Among Adults With Schizophrenia

NCT00391677

Schizophrenia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia and Disorders With Psychotic Features Psychotic Episode

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SocialMIND

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.

Group Type EXPERIMENTAL

SocialMIND

Intervention Type BEHAVIORAL

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.

Psychosocial treatment

Intervention Type BEHAVIORAL

Treatment as usual delivered by patient's practitioner

Psychotropic treatment

Intervention Type DRUG

Treatment as usual delivered by patient's practitioner

Psychoeducational Multicomponent Intervention

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.

Group Type ACTIVE_COMPARATOR

Psychoeducational multicomponent intervention

Intervention Type BEHAVIORAL

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.

Psychosocial treatment

Intervention Type BEHAVIORAL

Treatment as usual delivered by patient's practitioner

Psychotropic treatment

Intervention Type DRUG

Treatment as usual delivered by patient's practitioner

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SocialMIND

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.

Intervention Type BEHAVIORAL

Psychoeducational 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.

Intervention Type BEHAVIORAL

Psychosocial treatment

Treatment as usual delivered by patient's practitioner

Intervention Type BEHAVIORAL

Psychotropic treatment

Treatment as usual delivered by patient's practitioner

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Mindfulness-based social cognition training Mindfulness-based social cognition group training MB-SCT PMI Structured psychoeducational group Psychoeducational group Psychoeducation group Drug treatment

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No