Mindfulness-based Social Cognition Training for Psychosis (SocialMind): A Feasibility Study

Instituto de Investigación Hospital Universitario La Paz

Status: Completed

Conditions: Schizophrenia and Disorders With Psychotic Feature; Psychotic Episode

Treatments: Drug: Psychotropic treatment; Behavioral: Psychosocial treatment; Behavioral: SocialMind

Study type: Interventional

Funder types: Other

Identifiers

NCT03434405

AGES-Mind Feasibility Study

Details and patient eligibility

About

The current investigation has been designed to test the feasibility of a mindfulness-based social cognition training (SocialMind) for people with a first episode of psychosis (AGES-Mind Study, NCT03309475). The intervention has been designed by professionals with both formal training and clinical experience in the field of mindfulness and third generation cognitive-behavioral therapies. Main outcomes are recruitment rate, adverse events and treatment adherence, although therapy effects and adjustment to intervention manual are also explored.

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. This research team developed a mindfulness-based social cognition group training (SocialMind) designed for persons who have suffered a first episode of psychosis within five years prior to their enrollment in the study (AGES-Mind Study, NCT03309475). Although there is enough evidence to support the lack of adverse events derived for mindfulness-based interventions specifically designed for psychotic patients (Cramer et al., 2016), many clinicians express their concerns about the beneficial effects of these approaches. Therefore, and in keeping with international health organisms such as United Kingdom's National Health Service (NHS), this team have proposed a feasibility study. The main hypothesis is that the AGES-Mind study can be carried out in terms of achievement of recruitment rate, lack of adverse events and levels of treatment adherence. Secondary hypothesis states that clinicians will adhere to SocialMind manual. Finally, a positive effect of the intervention is expected, both in participants' satisfaction and in some relevant variables, such as functional outcomes, clinical global impression and social cognition.

Enrollment: 27 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-60 years old
• Diagnosis of psychotic disorder according to DSM-5 and history of more than five years of psychotic symptoms
• CGI-SCH equal or lower than four points ("moderately ill")
• Informed consent given

Exclusion criteria

• Intellectual disability plus impaired global functioning prior to disorder onset
• Generalized development disorder
• Substance related disorders (except for nicotine) according to DSM-5

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

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: SocialMind

Behavioral: Psychosocial treatment

Drug: Psychotropic treatment