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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Spain
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
Other Names:
  • Mindfulness-based social cognition training
  • Mindfulness-based social cognition group training
  • MB-SCT
Behavioral: Psychosocial treatment
Treatment as usual delivered by patient's practitioner
Drug: Psychotropic treatment
Treatment as usual delivered by patient's practitioner

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: 0 weeks
At least 25 participants meeting inclusion criteria
0 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Instituto de Investigación Hospital Universitario La Paz

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 25, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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Conditions

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