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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    80
  • sponsor
    Instituto de Investigación Hospital Universitario La Paz
Updated on 4 October 2022

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.

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.

Details
Condition Schizophrenia and Disorders With Psychotic Features, Psychotic Episode
Treatment Psychosocial Treatment, SocialMind, Psychotropic treatment, Structured psychoeducation, Psychoeducational multicomponent intervention
Clinical Study IdentifierNCT03309475
SponsorInstituto de Investigación Hospital Universitario La Paz
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

-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
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