ClinicalTrials.gov
ClinicalTrials.gov Menu

Mindfulness-based Social Cognition Training for Psychosis (SocialMind): A Feasibility Study

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.
ClinicalTrials.gov Identifier: NCT03434405
Recruitment Status : Not yet recruiting
First Posted : February 15, 2018
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
Instituto de Investigación Hospital Universitario La Paz

Brief Summary:
The current investigation has been designed to test the feasibility of a mindfulness-based social cognition training (SocialMind) for people with a first episode of psychosis (AGES-Mind Study, NCT03309475). The intervention has been designed by professionals with both formal training and clinical experience in the field of mindfulness and third generation cognitive-behavioral therapies. Main outcomes are recruitment rate, adverse events and treatment adherence, although therapy effects and adjustment to intervention manual are also explored.

Condition or disease Intervention/treatment Phase
Schizophrenia and Disorders With Psychotic Feature Psychotic Episode Behavioral: SocialMind 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. This research team developed a mindfulness-based social cognition group training (SocialMind) designed for persons who have suffered a first episode of psychosis within five years prior to their enrollment in the study (AGES-Mind Study, NCT03309475). Although there is enough evidence to support the lack of adverse events derived for mindfulness-based interventions specifically designed for psychotic patients (Cramer et al., 2016), many clinicians express their concerns about the beneficial effects of these approaches. Therefore, and in keeping with international health organisms such as United Kingdom's National Health Service (NHS), this team have proposed a feasibility study. The main hypothesis is that the AGES-Mind study can be carried out in terms of achievement of recruitment rate, lack of adverse events and levels of treatment adherence. Secondary hypothesis states that clinicians will adhere to SocialMind manual. Finally, a positive effect of the intervention is expected, both in participants' satisfaction and in some relevant variables, such as functional outcomes, clinical global impression and social cognition.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multi-center, rater-blinded, prospective (48 weeks follow-up), non-randomized, controlled (versus treatment as usual [TAU]), clinical trial. The experimental arm will receive TAU (both drug and psychosocial therapy) and mindfulness-based social cognition group training (SocialMind), specifically designed for patients with first episode psychosis by the research team. The control arm will receive TAU (both drug and psychosocial therapy). Participants will be assigned to either experimental arm or control arm according to their preferences.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mindfulness-based Social Cognition Group Training for Persons With Diagnoses of Psychotic Disorders (SocialMind): A Feasibility, Non-randomized Controlled Trial
Estimated Study Start Date : March 25, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

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

TAU
The control arm will receive treatment as usual (TAU), consisting on both psychotropic and psychosocial treatment delivered by patients' practitioner(s)
Behavioral: Psychosocial treatment
Treatment as usual delivered by patient's practitioner

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




Primary Outcome Measures :
  1. Recruitment rate [ Time Frame: 0 weeks ]
    At least 25 participants meeting inclusion criteria


Secondary Outcome Measures :
  1. Attrition rate [ Time Frame: 16 weeks ]
    Attrition rate lower than 30% on the experimental arm

  2. Change in Psychiatric Symptoms [ Time Frame: 8, 16, 36 and 48 weeks ]
    Psychiatric symptoms are measured by the 90 Symptoms Check List Revised (SCL-90-R) that explores 9 domains of psychopathology and provides 3 general scales. Higher values indicate higher symptomatology within each scale.

  3. Change in dissociative Symptoms [ Time Frame: 8, 16, 36 and 48 weeks ]
    Dissociative symptoms are measured by Dissociative Experiences Scale (DES-II), a scale that explores the frequency of several dissociative experiences. There is only one scale. Higher values indicate more dissociative experiences

  4. State anxiety [ Time Frame: 8, 16, 36 and 48 weeks ]
    State anxiety within sessions (before and after the training) are measured by the State scale of the State-Trait Anxiety Inventory (STAI-S). Higher values indicate higher anxiety symptoms in one general scale.

  5. Participants' satisfaction [ Time Frame: 36 weeks ]
    Client Satisfaction Questionnaire (CSQ-8) is a self-reported measure of therapy satisfaction. It provides one unique dimension, with higher values indicating more satisfaction with the intervention.

  6. 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. There are four scales (positive, negative, cognitive and depressive symptoms) and one general scale. Higher values indicate a worst clinical impression.

  7. Change in social functioning [ Time Frame: 8, 16, 36 and 48 weeks ]
    Personal and Social Performance Scale (PSP) explores four domains of social functioning (self-care, social relationships, social activities and disruptive and aggressive behavior. There are four specific scales from each domain (range 1-7) and one general scale (range 1-100). Higher values indicate worst functioning within each of the four specific areas, but better general functioning in the general scale.

  8. Change in time use [ Time Frame: 8, 16, 36 and 48 weeks ]
    Time Use Survey (TUS) register the amount of time spent in work, education, voluntary work, leisure, sports, housework and children's care. Higher values indicate more time spent on each area.

  9. Change quality of life [ Time Frame: 8, 16, 36 and 48 weeks ]
    Quality of life is measured by the instrument designed by the World Health Organization WHOQOL-BREF. There is only one dimension, with higher values indicating worst quality of life.

  10. Change in theory of mind [ Time Frame: 8, 16, 36 and 48 weeks ]
    Reduced version of the hinting task measures theory of mind ability through five different stories. The test provides one scale (from 0 to 10 points). Higher values indicate better performance.

  11. Change in emotion recognition [ Time Frame: 8, 16, 36 and 48 weeks ]
    The Reading the Mind in the Eyes Test (RMET) measures the ability to recognize different complex emotions on several faces. There is only one dimension. Higher values indicate more emotions correctly recognized (from 0 to 40).

  12. Change in social attribution [ Time Frame: 8, 16, 36 and 48 weeks ]
    The Attribution Intentions Hostility Questionnaire (AIHQ) measures people's disposition to interpret different ambiguous situations as hostile or neutral. Two main domains are hostility bias and aggression bias. Higher values indicate stronger biases.

  13. 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. There is only one dimension (from 0 to 56), with higher values indicating a stronger ability to mentalize.

  14. Change in mindful attention and awareness [ Time Frame: 8, 16, 36 and 48 weeks ]
    Mindful Attention and Awareness Scale (MAAS) measures this key aspect of mindful disposition. There is only one dimension (from 0 to 90), with higher values indicating better attention and awareness

  15. Change in neurocognitive status [ Time Frame: 8 and 16 weeks ]
    Screening of Cognitive Impairment in Psychiatry for Schizophrenia (SCIP-S) explores five major cognitive domains: immediate verbal learning, delayed verbal learning, working memory, verbal fluency and processing speed. There are five specific domains (each of them provides a different cut-off point) and a general scale (less than 67 points suggests cognitive impairment).


Other Outcome Measures:
  1. Clinician's adjustment to treatment protocol [ Time Frame: 36 weeks ]
    Independent raters assess practitioner's adherence to treatment manual after analyzing recorded sessions



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:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-60 years old
  • Diagnosis of psychotic disorder according to DSM-5
  • CGI-SCH equal or lower than four points ("moderately ill")
  • Informed consent given

Exclusion Criteria:

  • Less than a five year history of psychotic symptoms
  • Intellectual disability plus impaired global functioning prior to disorder onset
  • Generalized development disorder
  • History of cerebral concussion with traumatic unconsciousness
  • Pregnancy
  • Have ever participated in mindfulness programs
  • Substance related disorders (except for nicotine) according to DSM-5

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): NCT03434405


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

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: NCT03434405     History of Changes
Other Study ID Numbers: AGES-Mind Feasibility Study
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: January 2018
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:
schizophrenia
mindfulness
social cognition
SocialMind
AGES-Mind

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