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

Psychotic Episode Clinical Trial

Official title:

Mindfulness-based Social Cognition Group Training for Persons With Diagnoses of Psychotic Disorders (SocialMind): A Feasibility, Non-randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03434405
• Other study ID #: AGES-Mind Feasibility Study
• Status: Completed
• Phase: N/A
• Start date: February 25, 2018
• Est. completion date: June 30, 2018

Study information

• Verified date: January 2018
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders
• Psychotic Episode
• Schizophrenia
• Schizophrenia and Disorders With Psychotic Feature
• Schizophrenia Spectrum and Other Psychotic Disorders

Intervention

Behavioral:
• 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.
• Psychosocial treatment
Treatment as usual delivered by patient's practitioner

Drug:
• Psychotropic treatment
Treatment as usual delivered by patient's practitioner

Locations

Country	Name	City	State
Spain	La Paz University Hospital	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinician's adjustment to treatment protocol	Independent raters assess practitioner's adherence to treatment manual after analyzing recorded sessions	8 weeks
Primary	Recruitment rate	At least 25 participants meeting inclusion criteria	0 weeks
Secondary	Attrition rate	Attrition rate lower than 30% on the experimental arm	8 weeks
Secondary	Change in Psychiatric Symptoms	Psychiatric symptoms are measured by the 90 Symptoms Check List Revised (SCL-90-R) that explores 9 domains of psychopathology and provides 3 general scales. Higher values indicate higher symptomatology within each scale.	8 weeks
Secondary	Change in dissociative Symptoms	Dissociative symptoms are measured by Dissociative Experiences Scale (DES-II), a scale that explores the frequency of several dissociative experiences. There is only one scale. Higher values indicate more dissociative experiences	8 weeks
Secondary	State anxiety	State anxiety within sessions (before and after the training) are measured by the State scale of the State-Trait Anxiety Inventory (STAI-S). Higher values indicate higher anxiety symptoms in one general scale.	8 weeks
Secondary	Participants' satisfaction	Client Satisfaction Questionnaire (CSQ-8) is a self-reported measure of therapy satisfaction. It provides one unique dimension, with higher values indicating more satisfaction with the intervention.	8 weeks
Secondary	Change in clinical global impression	Clinical Global Impression Scale for Schizophrenia (CGI-SCH) measures patients' clinical state and clinical change over time. There are four scales (positive, negative, cognitive and depressive symptoms) and one general scale. Higher values indicate a worst clinical impression.	8 weeks
Secondary	Change in social functioning	Personal and Social Performance Scale (PSP) explores four domains of social functioning (self-care, social relationships, social activities and disruptive and aggressive behavior. There are four specific scales from each domain (range 1-7) and one general scale (range 1-100). Higher values indicate worst functioning within each of the four specific areas, but better general functioning in the general scale.	8 weeks
Secondary	Change quality of life	Quality of life is measured by the instrument designed by the World Health Organization WHOQOL-BREF. There is only one dimension, with higher values indicating worst quality of life.	8 weeks
Secondary	Change in theory of mind	Reduced version of the hinting task measures theory of mind ability through five different stories. The test provides one scale (from 0 to 10 points). Higher values indicate better performance.	8 weeks
Secondary	Change in emotion recognition	The Reading the Mind in the Eyes Test (RMET) measures the ability to recognize different complex emotions on several faces. There is only one dimension. Higher values indicate more emotions correctly recognized (from 0 to 40).	8 weeks
Secondary	Change in social attribution	The Attribution Intentions Hostility Questionnaire (AIHQ) measures people's disposition to interpret different ambiguous situations as hostile or neutral. Two main domains are hostility bias and aggression bias. Higher values indicate stronger biases.	8 weeks
Secondary	Change in reflective functioning	Reflective Functioning Questionnaire (RFQ-8) measures mentalization ability through a set of 8 questions. There is only one dimension (from 0 to 56), with higher values indicating a stronger ability to mentalize.	8 weeks
Secondary	Change in mindful attention and awareness	Mindful Attention and Awareness Scale (MAAS) measures this key aspect of mindful disposition. There is only one dimension (from 0 to 90), with higher values indicating better attention and awareness	8 weeks
Secondary	Change in neurocognitive status	Screening of Cognitive Impairment in Psychiatry for Schizophrenia (SCIP-S) explores five major cognitive domains: immediate verbal learning, delayed verbal learning, working memory, verbal fluency and processing speed. There are five specific domains (each of them provides a different cut-off point) and a general scale (less than 67 points suggests cognitive impairment).	8 weeks

External Links

•   AGES-Mind in ClinicalTrials.gov
•   La Paz University Hospital
•   Research team in IdiPAZ