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

NCT03309475 | Completed

• 1 other identifier: AGES-Mind
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia and Disorders With Psychotic Features; Psychotic Episode

Keywords

first episode psychosis; early psychosis; schizophrenia; mindfulness; social cognition; social functioning; AGES-Mind; SocialMind

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Change in global functioning

  8, 16, 36 and 48 weeks

• Change in quality of life

  8, 16, 36 and 48 weeks

• Change in clinical global impression

  8, 16, 36 and 48 weeks

• Change in psychotic symptoms

  8, 16, 36 and 48 weeks

• Change in depressive symptoms

  8, 16, 36 and 48 weeks

Study Arms (2)

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.

Behavioral: SocialMIND; Behavioral: Psychosocial treatment; Drug: Psychotropic treatment

Psychoeducational Multicomponent Intervention

ACTIVE COMPARATOR

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: Psychoeducational multicomponent intervention; Behavioral: Psychosocial treatment; Drug: Psychotropic treatment

Interventions

SocialMIND BEHAVIORAL

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.

Also known as: Mindfulness-based social cognition training, Mindfulness-based social cognition group training, MB-SCT

SocialMIND

Psychoeducational multicomponent intervention BEHAVIORAL

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.

Also known as: PMI, Structured psychoeducational group, Psychoeducational group, Psychoeducation group

Psychoeducational Multicomponent Intervention

Psychosocial treatment BEHAVIORAL

Treatment as usual delivered by patient's practitioner

Psychoeducational Multicomponent Intervention; SocialMIND

Psychotropic treatment DRUG

Treatment as usual delivered by patient's practitioner

Also known as: Drug treatment

Psychoeducational Multicomponent Intervention; SocialMIND

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto de Investigación Hospital Universitario La Paz: lead
• Carlos III Health Institute: collaborator
• European Regional Development Fund: collaborator

Study Sites (1)

La Paz University Hospital

Madrid, 28046, Spain

Location

Related Publications (4)

• 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.

  PMID: 25759473 BACKGROUND

• 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.

  PMID: 15888423 BACKGROUND

• 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.

  PMID: 24613006 BACKGROUND

• 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.

  PMID: 31357965 DERIVED

Related Links

• AGES-CM Consortium

MeSH Terms

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Schizophrenia; Social Adjustment

Condition Hierarchy (Ancestors)

Mental Disorders; Social Behavior; Behavior

Study Officials

• Maria Fe Bravo, MD, PhD

  Instituto para la Investigación Biomédica del Hospital universitario La Paz (IdiPAZ)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The evaluators will not know the patients' assigned treatment arm until the end of the follow-up period. This information will only be delivered to investigators in charge of intervention groups, but not to those in charge of statistical analyses.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot, multi-center, rater-blinded, prospective (48-weeks follow-up), randomized, controlled (versus active comparator \[psychoeducation\]), clinical trial. The experimental arm will receive treatment as usual (both drug and psychosocial therapy) and mindfulness-based social cognition group training, specifically designed for patients with first episode psychosis by the research team. The active comparator arm will receive treatment as usual (both drug and psychosocial therapy) and psychoeducation group training for psychosis.

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: October 13, 2017
• Study Start: September 1, 2018
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: January 9, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be available after the final results are published and for ever
• Access Criteria: Researchers that are interested should contact the Principal Investigator

Locations

ES (1)