Effectiveness of a Mindfulness-based Group Training Addressing Social Cognition in First Episode Psychosis (AGES-Mind) (AGES-Mind)

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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia and Disorders With Psychotic Features; Psychotic Episode
• Intervention / Treatment: Behavioral: Psychosocial treatment; Drug: Psychotropic treatment; Behavioral: SocialMIND; Behavioral: Psychoeducational multicomponent intervention

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. 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.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28046
    • La Paz University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

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.	Behavioral: Psychosocial treatment; Treatment as usual delivered by patient's practitioner; Drug: Psychotropic treatment; Treatment as usual delivered by patient's practitioner; Other Names: Drug treatment; 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
Active Comparator: Psychoeducational Multicomponent Intervention; The active comparator arm will receive treatment as usual (both psychotropic treatment and psychosocial treatment) and a psychoeducational multicomponent intervention for psychosis.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 7 monthly sessions.	Behavioral: Psychosocial treatment; Treatment as usual delivered by patient's practitioner; Drug: Psychotropic treatment; Treatment as usual delivered by patient's practitioner; Other Names: Drug treatment; Behavioral: 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.; Other Names: PMI; Structured psychoeducational group; Psychoeducational group; Psychoeducation group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Change in anxiety symptoms	Beck Anxiety Inventory (BAI) measures clinical anxiety through 21 items.	8, 16, 36 and 48 weeks
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
Change in reflective functioning	Reflective Functioning Questionnaire (RFQ-8) measures mentalization ability through a set of 8 questions	8, 16, 36 and 48 weeks
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
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
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
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
Change in oxidative stress and anti-inflammatory response	Total antioxidant status, enzymatic activity and cytokines	8 and 48 weeks

Collaborators and Investigators

• Sponsor: Instituto de Investigación Hospital Universitario La Paz
• Collaborators: Carlos III Health Institute; European Regional Development Fund
• Investigators: Principal Investigator: Maria Fe Bravo, MD, PhD, Instituto para la Investigación Biomédica del Hospital universitario La Paz (IdiPAZ)

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• Mediavilla R, Munoz-Sanjose A, Rodriguez-Vega B, Bayon C, Palao A, Lahera G, Sanchez-Castro P, Roman E, Cebolla S, de Diego A, Pastor JM, Bravo-Ortiz MF. Mindfulness-based social cognition training (SocialMIND) versus psychoeducational multicomponent intervention for people with a first episode of psychosis: a study protocol for a randomised controlled trial. BMC Psychiatry. 2019 Jul 29;19(1):233. doi: 10.1186/s12888-019-2206-4.

Helpful Links

• Research team in IdiPAZ
• La Paz University Hospital
• AGES-CM Consortium

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: September 27, 2017
• First Submitted That Met QC Criteria: October 12, 2017
• First Posted (Actual): October 13, 2017

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: schizophrenia; social cognition; social functioning; mindfulness; early psychosis; first episode psychosis; SocialMind; AGES-Mind
• Additional Relevant MeSH Terms: Schizophrenia; Psychotic Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Psychotropic Drugs
• Other Study ID Numbers: AGES-Mind

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data will be available on request.
• IPD Sharing Time Frame: The data will be available after the final results are published and for ever
• IPD Sharing Access Criteria: Researchers that are interested should contact the Principal Investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No