- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03434405
Mindfulness-based Social Cognition Training for Psychosis (SocialMind): A Feasibility Study
February 12, 2019 updated by: Instituto de Investigación Hospital Universitario La Paz
Mindfulness-based Social Cognition Group Training for Persons With Diagnoses of Psychotic Disorders (SocialMind): A Feasibility, Non-randomized Controlled Trial
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Madrid, Spain, 28045
- La Paz University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SocialMind
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.
|
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.
Other Names:
Treatment as usual delivered by patient's practitioner
Treatment as usual delivered by patient's practitioner
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recruitment rate
Time Frame: 0 weeks
|
At least 25 participants meeting inclusion criteria
|
0 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Attrition rate
Time Frame: 8 weeks
|
Attrition rate lower than 30% on the experimental arm
|
8 weeks
|
Change in Psychiatric Symptoms
Time Frame: 8 weeks
|
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
|
Change in dissociative Symptoms
Time Frame: 8 weeks
|
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
|
State anxiety
Time Frame: 8 weeks
|
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
|
Participants' satisfaction
Time Frame: 8 weeks
|
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
|
Change in clinical global impression
Time Frame: 8 weeks
|
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
|
Change in social functioning
Time Frame: 8 weeks
|
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
|
Change quality of life
Time Frame: 8 weeks
|
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
|
Change in theory of mind
Time Frame: 8 weeks
|
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
|
Change in emotion recognition
Time Frame: 8 weeks
|
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
|
Change in social attribution
Time Frame: 8 weeks
|
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
|
Change in reflective functioning
Time Frame: 8 weeks
|
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
|
Change in mindful attention and awareness
Time Frame: 8 weeks
|
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
|
Change in neurocognitive status
Time Frame: 8 weeks
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinician's adjustment to treatment protocol
Time Frame: 8 weeks
|
Independent raters assess practitioner's adherence to treatment manual after analyzing recorded sessions
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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]
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 25, 2018
Primary Completion (Actual)
June 30, 2018
Study Completion (Actual)
June 30, 2018
Study Registration Dates
First Submitted
February 2, 2018
First Submitted That Met QC Criteria
February 8, 2018
First Posted (Actual)
February 15, 2018
Study Record Updates
Last Update Posted (Actual)
February 15, 2019
Last Update Submitted That Met QC Criteria
February 12, 2019
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AGES-Mind Feasibility Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Schizophrenia and Disorders With Psychotic Feature
-
University of MinnesotaUniversity of California, San FranciscoCompletedSchizophrenia | Schizoaffective Disorder | Psychosis | Psychosis NOS | Schizophreniform Disorders | Unspecified Psychosis | Bipolar Disorder With Psychotic Features | Depression Psychotic FeatureUnited States
-
Instituto de Investigación Hospital Universitario...Carlos III Health Institute; European Regional Development FundCompletedSchizophrenia and Disorders With Psychotic Features | Psychotic EpisodeSpain
-
The Hong Kong Polytechnic UniversityUniversity of Turku; University of Helsinki; Kowloon Hospital, Hong Kong; Pamela... and other collaboratorsCompletedCognitive Function | Schizophrenia and Disorders With Psychotic FeaturesHong Kong
-
Fundación Pública Andaluza para la gestión de la...RecruitingNegative Symptoms With Primary Psychotic Disorder | Cognitive Impairment With Primary Psychotic DisorderSpain
-
Yale UniversityCompletedSchizophrenia and Disorders With Psychotic FeaturesUnited States
-
MaineHealthColumbia University; University of California, Irvine; Harvard UniversityCompletedPsychotic Disorders | Prodromal Schizophrenia | Severe Major Depression With Psychotic Features | Severe Bipolar Disorder With Psychotic FeaturesUnited States
-
University of ManchesterKing's College London; Northern Care Alliance NHS Foundation Trust; University... and other collaboratorsCompletedSchizophrenia and Disorders With Psychotic Features
-
University of Sao PauloUnknownSchizophrenia and Disorders With Psychotic FeaturesBrazil
-
Federal Neuro-Psychiatric Hospital, YabaUnknownSchizophrenia and Disorders With Psychotic FeaturesNigeria
-
University of RegensburgUniversity Hospital Ostrava; Brno University Hospital; University Hospital, AachenRecruitingSchizophrenia | Negative Symptoms With Primary Psychotic DisorderCzechia, Germany
Clinical Trials on SocialMind
-
Instituto de Investigación Hospital Universitario...Carlos III Health Institute; European Regional Development FundCompletedSchizophrenia and Disorders With Psychotic Features | Psychotic EpisodeSpain