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

Instituto de Investigación Hospital Universitario La Paz

Status: Completed

Conditions: Schizophrenia and Disorders With Psychotic Features; Psychotic Episode

Treatments: Behavioral: SocialMIND; Drug: Psychotropic treatment; Behavioral: Psychoeducational multicomponent intervention; Behavioral: Psychosocial treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03309475

AGES-Mind

Details and patient eligibility

About

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.

Full 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.

Enrollment: 59 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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59 participants in 2 patient groups

SocialMIND

Experimental group

Description:

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.

Treatment:

Behavioral: Psychosocial treatment

Drug: Psychotropic treatment

Behavioral: SocialMIND

Psychoeducational Multicomponent Intervention

Active Comparator group

Description:

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.

Treatment:

Behavioral: Psychosocial treatment

Behavioral: Psychoeducational multicomponent intervention

Drug: Psychotropic treatment