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Completed

NCT Number: NCT03309475

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

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.

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Key information

Conditions

Schizophrenia and Disorders With Psychotic Features Behavior Mental Disorders Psychotic Disorders Psychotic Episode Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Social Adjustment Social Behavior

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

La Paz University Hospital

Madrid, 28046, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Mindfulness-based social cognition training, Mindfulness-based social cognition group training, MB-SCT

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.

Other names: PMI, Structured psychoeducational group, Psychoeducational group, Psychoeducation group

Psychosocial treatment

Behavioral

Treatment as usual delivered by patient's practitioner

Psychotropic treatment

Drug

Treatment as usual delivered by patient's practitioner

Other names: Drug treatment

Primary outcomes

  1. Change in social functioning

    Time frame: 8, 16, 36 and 48 weeks

    Personal and Social Performance Scale (PSP) measures patient's functioning on different social areas, such as self-care, relationships, social activities and aggressive behavior.

Secondary outcomes

  1. Change in global functioning

    Time frame: 8, 16, 36 and 48 weeks

    Global Assessment of Functioning Scale (GAF) measures patient's general functioning using a single 0-100 scale.

  2. Change in quality of life

    Time frame: 8, 16, 36 and 48 weeks

    WHOQOL-BREF measures patient's quality of life according to World Health Organization parameters.

  3. Change in clinical global impression

    Time frame: 8, 16, 36 and 48 weeks

    Clinical Global Impression Scale for Schizophrenia (CGI-SCH) measures patients' clinical state and clinical change over time

  4. Change in psychotic symptoms

    Time frame: 8, 16, 36 and 48 weeks

    Positive and Negative Symptoms Scale for Schizophrenia (PANSS) measures psychotic syndrome through a detailed clinical interview.

  5. Change in depressive symptoms

    Time frame: 8, 16, 36 and 48 weeks

    Calgary Depression Scale for Schizophrenia (CDSS) measures depressive symptoms in psychotic patients through a personal interview

  6. Change in anxiety symptoms

    Time frame: 8, 16, 36 and 48 weeks

    Beck Anxiety Inventory (BAI) measures clinical anxiety through 21 items.

  7. Change in social cognition

    Time frame: 8, 16, 36 and 48 weeks

    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. Change in reflective functioning

    Time frame: 8, 16, 36 and 48 weeks

    Reflective Functioning Questionnaire (RFQ-8) measures mentalization ability through a set of 8 questions

  9. Change in emotional intelligence

    Time frame: 8, 16, 36 and 48 weeks

    Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT v2.0) measures emotional intelligence through a set of questions referred to different situations.

  10. Change in mindful attention and awareness

    Time frame: 8, 16, 36 and 48 weeks

    Mindfulness Attention Awareness Scale (MAAS) measures processes thought to be related to clinical outcomes in mindfulness-based interventions.

  11. Change in cognitive insight

    Time frame: 8, 16, 36 and 48 weeks

    Beck Cognitive Insight Scale (BCIS) explores self-reflection and self-certainty, as parts of the cognitive insight construct

  12. Change in neurocognition

    Time frame: 8, 16, 36 and 48 weeks

    Four tasks of the Matrics Consensus Cognitive Battery (MCCB) measure different domains of neurocognition (symbol coding, letter number span, spatial span and CPT-IP)

  13. Change in oxidative stress and anti-inflammatory response

    Time frame: 8 and 48 weeks

    Total antioxidant status, enzymatic activity and cytokines

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Hospital Universitario La Paz

Other

Collaborators

  • Carlos III Health Institute
  • European Regional Development Fund

Registry information

Official study 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

Acronym: AGES-Mind

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Oct 13, 2017
Registry last updated
Jan 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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