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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03309475
Other study ID # AGES-Mind
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2018
Est. completion date January 31, 2023

Study information

Verified date October 2023
Source Instituto de Investigación Hospital Universitario La Paz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The current investigation aims to compare two group intervention in patients with a first episode of psychosis, that is, people who have suffered their first psychotic episode within 5 years prior to their inclusion in the study. The experimental arm is a mindfulness-based social cognition training (SocialMind) designed by professionals with both formal training and clinical experience in the field of mindfulness and third generation cognitive-behavioral therapies. The active comparator arm is a psychoeducation program specifically designed for individuals with recent onset psychosis by members of the team with great experience in delivering such interventions. The main outcome is social functioning, as measured by the Personal and Social Performance Scale (PSP), an instrument developed for psychotic patients. The main hypothesis is that the improvement in social functioning will be larger among the participants on the experimental arm, because there is enough evidence suggesting that deficits in social cognition are present even in the first stages of psychotic syndrome and related to social functioning and general disability. Moreover, mindfulness-based interventions have proven themselves effective in other severe mental disorders.


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. Investigators' main hypothesis is that a mindfulness-based social cognition group training (SocialMind) will improve social and general functioning, and that this improvement will be higher in the SocialMind than in the psychoeducation group. Given the association between oxidative stress and cognitive functioning, a relationship between oxidative stress biomarkers and intervention-related variables is also expected. A research team with more than ten mental health professionals and many collaborators will carry and oversee the assessment sessions. A Pharmacology Department will analyse the biological samples. Regulated-trained, well-experienced clinicians will design and administer both interventions. The whole team will take part in the process of scientific publication and results dissemination.


Recruitment information / eligibility

Status Completed
Enrollment 59
Est. completion date January 31, 2023
Est. primary completion date January 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - 18-45 years old - First hospitalization, first visit to mental health services with positive symptoms, onset of antipsychotic treatment, or first appearance of positive symptoms confirmed by an informant within the period of five years prior to the enrolment in the study; - Informed consent given Exclusion Criteria: - Clinical Global Impression (CGI) higher than 5 ("markedly ill") - Other Axis I diagnoses, except for substance use if psychotic symptoms remain at least 14 days after negative urine test. - Intellectual disability plus impaired global functioning prior to disorder onset - Generalized development disorder - Pregnancy - Attendance to either mindfulness programs or structured psychoeducational interventions at the time of the enrolment

Study Design


Related Conditions & MeSH terms


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.
Psychoeducational multicomponent intervention
The psychoeducational multicomponent intervention addresses and discuss several aspects of great importance for persons who suffer a first episode of psychosis, such as biased perception and thinking, delusions-related anxiety or the nature of hallucinations. Its aim is to encourage patients to reflect upon their experiences from a critic perspective.
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 (3)

Lead Sponsor Collaborator
Instituto de Investigación Hospital Universitario La Paz Carlos III Health Institute, European Regional Development Fund

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Brune M. "Theory of mind" in schizophrenia: a review of the literature. Schizophr Bull. 2005 Jan;31(1):21-42. doi: 10.1093/schbul/sbi002. Epub 2005 Feb 16. — View Citation

Fond G, d'Albis MA, Jamain S, Tamouza R, Arango C, Fleischhacker WW, Glenthoj B, Leweke M, Lewis S, McGuire P, Meyer-Lindenberg A, Sommer IE, Winter-van Rossum I, Kapur S, Kahn RS, Rujescu D, Leboyer M. The promise of biological markers for treatment response in first-episode psychosis: a systematic review. Schizophr Bull. 2015 May;41(3):559-73. doi: 10.1093/schbul/sbv002. Epub 2015 Mar 10. — View Citation

Lecomte T, Corbiere M, Ehmann T, Addington J, Abdel-Baki A, Macewan B. Development and preliminary validation of the First Episode Social Functioning Scale for early psychosis. Psychiatry Res. 2014 May 30;216(3):412-7. doi: 10.1016/j.psychres.2014.01.044. Epub 2014 Feb 5. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in social functioning Personal and Social Performance Scale (PSP) measures patient's functioning on different social areas, such as self-care, relationships, social activities and aggressive behavior. 8, 16, 36 and 48 weeks
Secondary Change in global functioning Global Assessment of Functioning Scale (GAF) measures patient's general functioning using a single 0-100 scale. 8, 16, 36 and 48 weeks
Secondary Change in quality of life WHOQOL-BREF measures patient's quality of life according to World Health Organization parameters. 8, 16, 36 and 48 weeks
Secondary Change in clinical global impression Clinical Global Impression Scale for Schizophrenia (CGI-SCH) measures patients' clinical state and clinical change over time 8, 16, 36 and 48 weeks
Secondary Change in psychotic symptoms Positive and Negative Symptoms Scale for Schizophrenia (PANSS) measures psychotic syndrome through a detailed clinical interview. 8, 16, 36 and 48 weeks
Secondary Change in depressive symptoms Calgary Depression Scale for Schizophrenia (CDSS) measures depressive symptoms in psychotic patients through a personal interview 8, 16, 36 and 48 weeks
Secondary Change in anxiety symptoms Beck Anxiety Inventory (BAI) measures clinical anxiety through 21 items. 8, 16, 36 and 48 weeks
Secondary Change in social cognition Hinting task, Reading the Mind in the Eyes Test (RMET), Emotion Recognition task (ER-40) and Ambiguous Intentions and Attribution Questionnaire (AIHQ) measure main domains of social cognition. 8, 16, 36 and 48 weeks
Secondary Change in reflective functioning Reflective Functioning Questionnaire (RFQ-8) measures mentalization ability through a set of 8 questions 8, 16, 36 and 48 weeks
Secondary Change in emotional intelligence Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT v2.0) measures emotional intelligence through a set of questions referred to different situations. 8, 16, 36 and 48 weeks
Secondary Change in mindful attention and awareness Mindfulness Attention Awareness Scale (MAAS) measures processes thought to be related to clinical outcomes in mindfulness-based interventions. 8, 16, 36 and 48 weeks
Secondary Change in cognitive insight Beck Cognitive Insight Scale (BCIS) explores self-reflection and self-certainty, as parts of the cognitive insight construct 8, 16, 36 and 48 weeks
Secondary Change in neurocognition Four tasks of the Matrics Consensus Cognitive Battery (MCCB) measure different domains of neurocognition (symbol coding, letter number span, spatial span and CPT-IP) 8, 16, 36 and 48 weeks
Secondary Change in oxidative stress and anti-inflammatory response Total antioxidant status, enzymatic activity and cytokines 8 and 48 weeks
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