Clinical trial NCT03434405: Mindfulness-based Social Cognition Training for Psychosis (SocialMind): A Feasibility Study
Official title: Mindfulness-based Social Cognition Group Training for Persons With Diagnoses of Psychotic Disorders (SocialMind): A Feasibility, Non-randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia and Disorders With Psychotic Feature
Psychotic Episode
Keywords: schizophrenia
mindfulness
social cognition
SocialMind
AGES-Mind
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2018-02-15
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment rate
timeFrame: 0 weeks
Secondary outcomes:
measure: Attrition rate
timeFrame: 8 weeks
measure: Change in Psychiatric Symptoms
timeFrame: 8 weeks
measure: Change in dissociative Symptoms
timeFrame: 8 weeks
measure: State anxiety
timeFrame: 8 weeks
measure: Participants' satisfaction
timeFrame: 8 weeks
measure: Change in clinical global impression
timeFrame: 8 weeks
measure: Change in social functioning
timeFrame: 8 weeks
measure: Change quality of life
timeFrame: 8 weeks
measure: Change in theory of mind
timeFrame: 8 weeks
measure: Change in emotion recognition
timeFrame: 8 weeks
measure: Change in social attribution
timeFrame: 8 weeks
measure: Change in reflective functioning
timeFrame: 8 weeks
measure: Change in mindful attention and awareness
timeFrame: 8 weeks
measure: Change in neurocognitive status
timeFrame: 8 weeks
Other outcomes:
measure: Clinician's adjustment to treatment protocol
timeFrame: 8 weeks
Locations:
city: Madrid
country: Spain
facility: La Paz University Hospital
Study officials:
affiliation: Instituto para la Investigación Biomédica del Hospital Universitario La Paz [La Paz University Hospital Biomedical Research Institute]
name: Maria Fe Bravo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cramer H, Lauche R, Haller H, Langhorst J, Dobos G. Mindfulness- and Acceptance-based Interventions for Psychosis: A Systematic Review and Meta-analysis. Glob Adv Health Med. 2016 Jan;5(1):30-43. doi: 10.7453/gahmj.2015.083. Epub 2016 Jan 1.
citation: Mediavilla R, Munoz-Sanjose A, Rodriguez-Vega B, Bayon C, Lahera G, Palao A, Bravo-Ortiz MF. Mindfulness-Based Social Cognition Training (SocialMind) for People With Psychosis: A Feasibility Trial. Front Psychiatry. 2019 May 2;10:299. doi: 10.3389/fpsyt.2019.00299. eCollection 2019.