Schizophrenia and Disorders With Psychotic FeatureNCT03434405
Mindfulness-based Social Cognition Training for Psychosis (SocialMind): A Feasibility Study
A study testing SocialMind, Psychosocial treatment and Psychotropic treatment in people with Schizophrenia and Disorders With Psychotic Feature and Psychotic Episode, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia and Disorders With Psychotic Feature, Psychotic Episode
- What is being tested?
- SocialMind, Psychosocial treatment and Psychotropic treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSpain
- Study dates
- 25 Feb 2018to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Intellectual disability plus impaired global functioning prior to disorder onset
- Generalized development disorder
- Substance related disorders (except for nicotine) according to DSM-5
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- SocialMind, Psychosocial treatment, Psychotropic treatment
- Keywords
- schizophrenia, mindfulness, social cognition, SocialMind, AGES-Mind
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SocialMindBehavioural
Also called Mindfulness-based social cognition training, Mindfulness-based social cognition group training, MB-SCT
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 treatmentBehavioural
Treatment as usual delivered by patient's practitioner
Psychotropic treatmentDrug
Treatment as usual delivered by patient's practitioner
| Study group | Role | What they receive |
|---|---|---|
| SocialMind | Experimental | 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. Receives: Behavioral: SocialMind; Behavioral: Psychosocial treatment; Drug: Psychotropic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
At least 25 participants meeting inclusion criteria
Measured: 0 weeks
Secondary outcomes (14)
Attrition rate
Attrition rate lower than 30% on the experimental arm
Measured: 8 weeks
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.
Measured: 8 weeks
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
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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).
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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
Measured: 8 weeks
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).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start25 Feb 2018
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia and Disorders With Psychotic FeatureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Fe Bravo, MD, PhD, Principal investigator, Instituto para la Investigación Biomédica del Hospital Universitario La Paz [La Paz University Hospital Biomedical Research Institute]
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03434405
- Sponsor's protocol ID
- AGES-Mind Feasibility Study
- Status last verified
- Jan 2018
- First submitted
- 2 Feb 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 26937312Mediavilla 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.
PubMed 31118909
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-based Social Cognition Group Training for Persons With Diagnoses of Psychotic Disorders (SocialMind): A Feasibility, Non-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03434405
- Acronym / sponsor ID
- AGES-Mind Feasibility Study
- Keywords
- schizophrenia, mindfulness, social cognition, SocialMind, AGES-Mind
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Study start
- 25 Feb 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 15 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| SocialMind | Experimental | Behavioral: SocialMind, Behavioral: Psychosocial treatment, Drug: Psychotropic treatmentThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Intellectual disability plus impaired global functioning prior to disorder onset
- Generalized development disorder
- Substance related disorders (except for nicotine) according to DSM-5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SocialMindAlso: Mindfulness-based social cognition training, Mindfulness-based social cognition group training, MB-SCTSocialMind 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. | Behavioural | SocialMind |
| Psychosocial treatmentTreatment as usual delivered by patient's practitioner | Behavioural | SocialMind |
| Psychotropic treatmentTreatment as usual delivered by patient's practitioner | Drug | SocialMind |
Primary outcome
Recruitment rate
Time frame: 0 weeks
At least 25 participants meeting inclusion criteria
14 secondary outcomes
Attrition rate
Time frame: 8 weeks
Change in Psychiatric Symptoms
Time frame: 8 weeks
Change in dissociative Symptoms
Time frame: 8 weeks
State anxiety
Time frame: 8 weeks
Participants' satisfaction
Time frame: 8 weeks
Change in clinical global impression
Time frame: 8 weeks
Change in social functioning
Time frame: 8 weeks
Change quality of life
Time frame: 8 weeks
Change in theory of mind
Time frame: 8 weeks
Change in emotion recognition
Time frame: 8 weeks
Change in social attribution
Time frame: 8 weeks
Change in reflective functioning
Time frame: 8 weeks
Change in mindful attention and awareness
Time frame: 8 weeks
Change in neurocognitive status
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Background: PubMed 26937312Cramer 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.
- Derived from this study: PubMed 31118909Mediavilla 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.
- AGES-Mind in ClinicalTrials.govLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Fe Bravo, MD, PhD principal investigator
Instituto para la Investigación Biomédica del Hospital Universitario La Paz [La Paz University Hospital Biomedical Research Institute]
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SocialMind, Psychosocial treatment and Psychotropic treatment in people with Schizophrenia and Disorders With Psychotic Feature and Psychotic Episode, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 0 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03434405, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.