Clinical trial
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
Name
AGES-Mind
Description
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.
Trial arms
Trial start
2018-09-01
Estimated PCD
2023-01-31
Trial end
2023-01-31
Status
Completed
Treatment
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.
Arms:
SocialMIND
Other names:
Mindfulness-based social cognition training, Mindfulness-based social cognition group training, MB-SCT
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.
Arms:
Psychoeducational Multicomponent Intervention
Other names:
PMI, Structured psychoeducational group, Psychoeducational group, Psychoeducation group
Psychosocial treatment
Treatment as usual delivered by patient's practitioner
Arms:
Psychoeducational Multicomponent Intervention, SocialMIND
Psychotropic treatment
Treatment as usual delivered by patient's practitioner
Arms:
Psychoeducational Multicomponent Intervention, SocialMIND
Other names:
Drug treatment
Size
59
Primary endpoint
Change in social functioning
8, 16, 36 and 48 weeks
Eligibility 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
Protocol
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Updated at
2024-01-09
1 organization