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Trial record 4 of 51 for:    psychoeducation | Not yet recruiting Studies

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

This study is not yet open for participant recruitment.
Verified September 2017 by Instituto de Investigación Hospital Universitario La Paz
Sponsor:
ClinicalTrials.gov Identifier:
NCT03309475
First Posted: October 13, 2017
Last Update Posted: December 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Instituto de Investigación Hospital Universitario La Paz
  Purpose
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 24 months prior to their inclusion in the study. The experimental arm is a mindfulness-based social cognition training 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 Social Functioning Scale, 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 Intervention
Schizophrenia and Disorders With Psychotic Features Behavioral: MB-SCT Behavioral: Structured psychoeducation Behavioral: Psychosocial treatment Drug: Psychotropic treatment

Study Type: Interventional
Study Design: 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 Versus Group Psychoeducation in Patients With a First Episode of Psychosis (AGES-Mind Study): A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Instituto de Investigación Hospital Universitario La Paz:

Primary Outcome Measures:
  • Change in social functioning after intensive intervention [ Time Frame: 8 weeks ]
    Social Functioning Scale (SFS) measures patient's functioning on different social areas, such as work, family, couple or leisure


Secondary Outcome Measures:
  • Change in global functioning [ Time Frame: 8 weeks ]
    Global Assessment of Functioning Scale (GAF) measures patient's general functioning using a single 0-100 scale.

  • Change in emotional intelligence [ Time Frame: 8 weeks ]
    Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT v2.0) measures emotional intelligence through a set of questions referred to different situations.

  • Change in mindful attention and awareness [ Time Frame: 8 weeks ]
    Mindfulness Attention Awareness Scale (MAAS) measures processes thought to be related to clinical outcomes in mindfulness-based interventions.

  • Change in sustained attention [ Time Frame: 8 weeks ]
    Continous Performance Tes (CPT-III) measures individuals' capacity to keep their attention focused on a task for a 15-minutes period

  • Change in psychotic symptoms [ Time Frame: 8 weeks ]
    Positive and Negative Symptoms Scale for Schizophrenia (PANSS) measures psychotic syndrome through a detailed clinical interview.

  • Change in depressive symptoms [ Time Frame: 8 weeks ]
    Hamilton Depression Rating Scale (HDRS) is a 17-item scale that measures depression symptoms.

  • Change in anxiety symptoms [ Time Frame: 8 weeks ]
    Beck Anxiety Inventory (BAI) measures clinical anxiety through 21 items.

  • Change in cognitive insight [ Time Frame: 8 weeks ]
    Beck Cognitive Insight Scale (BCIS) explores self-reflection and self-certainty, as parts of the cognitive insight construct

  • Change in total antioxidant activity [ Time Frame: 8 weeks ]
    Plasma total antioxidant activity (mM)


Estimated Enrollment: 108
Anticipated Study Start Date: February 2018
Estimated Study Completion Date: December 31, 2020
Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MB-SCT
The experimental arm will receive treatment as usual (both psychotropic treatment and psychosocial treatment) and mindfulness-based social cognition group training (MB-SCT), specifically designed for patients with first episode psychosis by the research team. There will be a first phase (intensive group intervention) consisting of 8 weekly sessions and a second phase (follow-up group sessions) consisting of 7 monthly sessions.
Behavioral: MB-SCT
MB-SCT is a cognitive-behavioral intervention that incorporates mindfulness 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
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 group intervention) consisting of 8 weekly sessions and a second phase (follow-up group sessions) consisting of 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

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 (MB-SCT) will improve social and general functioning, and that this improvement will be higher in the MB-SCT 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 16-40 years old
  • No longer than a 2-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)
  Contacts and Locations
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]
  More Information

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 Submitted: September 27, 2017
First Posted: October 13, 2017
Last Update Posted: December 13, 2017
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

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