Schizophrenia and Disorders With Psychotic Features Clinical Trial
— AGES-MindOfficial title:
Mindfulness-based Social Cognition Group Training (SocialMIND) Versus Psychoeducational Multicomponent Intervention in Patients With a First Episode of Psychosis (AGES-Mind Study): A Randomized Controlled Trial
Verified date | October 2023 |
Source | Instituto de Investigación Hospital Universitario La Paz |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Spain | La Paz University Hospital | Madrid |
Lead Sponsor | Collaborator |
---|---|
Instituto de Investigación Hospital Universitario La Paz | Carlos III Health Institute, European Regional Development Fund |
Spain,
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
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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