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

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.

Conditions

• Schizophrenia and Disorders With Psychotic Features
• Psychotic Episode

Interventions

BEHAVIORAL

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.

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.

BEHAVIORAL

Psychosocial treatment

Treatment as usual delivered by patient's practitioner

DRUG

Psychotropic treatment

Treatment as usual delivered by patient's practitioner

Sponsors & Collaborators

• Carlos III Health Institute

  collaborator OTHER_GOV

• European Regional Development Fund

  collaborator OTHER

• Instituto de Investigación Hospital Universitario La Paz

  lead OTHER

Principal Investigators

• Maria Fe Bravo, MD, PhD · Instituto para la Investigación Biomédica del Hospital universitario La Paz (IdiPAZ)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-09-01

Primary Completion

2023-01-31

Completion

2023-01-31

Countries

• Spain

Study Locations