Mindfulness-based Social Cognition Training for Psychosis (SocialMind): A Feasibility Study
Last updated on July 2021Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 25
Summary
- Conditions
- Psychotic Episode
- Schizophrenia and Disorders With Psychotic Feature
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Multi-center, open-label, prospective, non-randomized, single-group, clinical trial. The experimental arm will receive TAU (both drug and psychosocial therapy) and mindfulness-based social cognition group training (SocialMind), specifically designed for patients with first episode psychosis by the research team.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 60 years
- Gender
- Both males and females
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 no...
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.
Tracking Information
- NCT #
- NCT03434405
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Maria Fe Bravo, MD, PhD Instituto para la Investigación Biomédica del Hospital Universitario La Paz [La Paz University Hospital Biomedical Research Institute]
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