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Trial record 4 of 43 for:    psychoeducation | Not yet recruiting Studies

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

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ClinicalTrials.gov Identifier: NCT03309475
Recruitment Status : Not yet recruiting
First Posted : October 13, 2017
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Instituto de Investigación Hospital Universitario La Paz

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.

Condition or disease Intervention/treatment Phase
Schizophrenia and Disorders With Psychotic Features Psychotic Episode Behavioral: SocialMind Behavioral: Structured psychoeducation Behavioral: Psychosocial treatment Drug: Psychotropic treatment Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The evaluators will not know the patients' asigned 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.
Primary Purpose: Treatment
Official Title: Mindfulness-based Social Cognition Group Training (SocialMind) Versus Group Psychoeducation in Patients With a First Episode of Psychosis (AGES-Mind Study): A Randomized Controlled Trial
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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: 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

Behavioral: Psychosocial treatment
Treatment as usual delivered by patient's practitioner

Drug: Psychotropic treatment
Treatment as usual delivered by patient's practitioner
Other Name: Drug treatment

Active Comparator: Structured psychoeducation
The active comparator arm will receive treatment as usual (both psychotropic treatment and psychosocial treatment) and psychoeducation group training 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: Structured psychoeducation
Structured psychoeducation 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:
  • Psychoeducation
  • Structured psychoeducational group
  • Psychoeducational group
  • Psychoeducation group

Behavioral: Psychosocial treatment
Treatment as usual delivered by patient's practitioner

Drug: Psychotropic treatment
Treatment as usual delivered by patient's practitioner
Other Name: Drug treatment




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-40 years old
  • No longer than a 5-year history of psychotic symptoms
  • Informed consent given

Exclusion Criteria:

  • 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
  • History of cerebral concussion with traumatic unconsciousness
  • Pregnancy
  • Patients who (a) are currently receiving either psychotherapy or structured psychoeducation for psychosis, (b) have gone to structured psychoeducation programs for psychosis in the past five years or (c) have ever participated in mindfulness programs
  • non-stabilized patients (according to Andreasen's criteria)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309475


Contacts
Contact: Maria Fe Bravo, MD, PhD (+34) 91 727 75 49 mfe.bravo@salud.madrid.org
Contact: Ainoa Munoz, MD, PhD (+34) 91 727 75 49 ainoa.munoz@salud.madrid.org

Locations
Spain
Hospital Universitario La Paz [La Paz University Hospital] Not yet recruiting
Madrid, Spain, 28046
Contact: Maria Fe Bravo, Doctor    (+34) 91 727 75 49    mfe.bravo@salud.madrid.org   
Contact: Ainoa Munoz, Doctor    (+34) 91 727 75 49    ainoa.munoz@salud.madrid.org   
Principal Investigator: Maria Fe Bravo, Doctor         
Sub-Investigator: Ainoa Munoz, Doctor         
Sponsors and Collaborators
Instituto de Investigación Hospital Universitario La Paz
Investigators
Principal Investigator: Maria Fe Bravo, MD, PhD Instituto para la Investigación Biomédica del Hospital Universitario La Paz [La Paz University Hospital Biomedical Research Institute]

Additional Information:
Publications:
Responsible Party: Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT03309475     History of Changes
Other Study ID Numbers: AGES-Mind
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Instituto de Investigación Hospital Universitario La Paz:
first episode psychosis
early psychosis
schizophrenia
mindfulness
social cognition
social functioning
AGES-Mind
SocialMind

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Psychotropic Drugs