Clinical trial NCT03309475: Effectiveness of a Mindfulness-based Group Training Addressing Social Cognition in First Episode Psychosis (AGES-Mind)
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia and Disorders With Psychotic Features
Psychotic Episode
Keywords: first episode psychosis
early psychosis
schizophrenia
mindfulness
social cognition
social functioning
AGES-Mind
SocialMind
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
Collaborators: name: Carlos III Health Institute
name: European Regional Development Fund
First posted: 2017-10-13
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in social functioning
timeFrame: 8, 16, 36 and 48 weeks
Secondary outcomes:
measure: Change in global functioning
timeFrame: 8, 16, 36 and 48 weeks
measure: Change in quality of life
timeFrame: 8, 16, 36 and 48 weeks
measure: Change in clinical global impression
timeFrame: 8, 16, 36 and 48 weeks
measure: Change in psychotic symptoms
timeFrame: 8, 16, 36 and 48 weeks
measure: Change in depressive symptoms
timeFrame: 8, 16, 36 and 48 weeks
measure: Change in anxiety symptoms
timeFrame: 8, 16, 36 and 48 weeks
measure: Change in social cognition
timeFrame: 8, 16, 36 and 48 weeks
measure: Change in reflective functioning
timeFrame: 8, 16, 36 and 48 weeks
measure: Change in emotional intelligence
timeFrame: 8, 16, 36 and 48 weeks
measure: Change in mindful attention and awareness
timeFrame: 8, 16, 36 and 48 weeks
measure: Change in cognitive insight
timeFrame: 8, 16, 36 and 48 weeks
measure: Change in neurocognition
timeFrame: 8, 16, 36 and 48 weeks
measure: Change in oxidative stress and anti-inflammatory response
timeFrame: 8 and 48 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: La Paz University Hospital
Study officials:
affiliation: Instituto para la Investigación Biomédica del Hospital universitario La Paz (IdiPAZ)
name: Maria Fe Bravo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
citation: 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.