Overview

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

Status:
Recruiting
Trial end date:
2024-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Instituto de Investigación Hospital Universitario La Paz
Collaborators:
Carlos III Health Institute
European Regional Development Fund
Treatments:
Psychotropic Drugs
Criteria
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