Social Cognition in Longstanding Psychosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Arizona
Sponsor:
Information provided by (Responsible Party):
Nicholas Breitborde, University of Arizona
ClinicalTrials.gov Identifier:
NCT01624831
First received: November 7, 2011
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

In the current study, the investigators propose to measure the five domains of social cognition identified by the National Institute of Mental Health (NIMH) as relevant to individuals with psychosis (i.e., theory of mind, attribution style, emotion recognition, social perception, and social knowledge). The investigators will also explore the association between different domains of social cognition and outcomes relevant to psychotic disorder (e.g., symptomatology, social functioning, and vocational functioning).


Condition
Schizophrenia
Schizoaffective Disorder
Bipolar Disorder With Psychotic Features
Major Depression With Psychotic Features
Psychosis Not Otherwise Specified (NOS)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Social Cognition in Longstanding Psychosis

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • Emotion Recognition [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Change from baseline to 6 month assessment in ability to recognize emotions displayed by others assessed using the Facial Emotion Identification Test

  • Attribution Style [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Change from baseline to 6 month assessment in tendency to attribute events that occur to situational, personal, or internal factors assessed using the Internal, Personal, and Situational Attributions Questionnaire

  • Social Perception [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Change from baseline to 6 month assessment in ability to understand concrete and abstract components of everyday social interactions assessed using the Social Cues Recognition Test

  • Social Knowledge [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Change from baseline to 6 month assessment in knowledge of goals and actions associated with familiar and unfamiliar social activities assessed using the Situational Features Recognition Test

  • Theory of Mind [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Change from baseline to 6 month assessment in ability to identify the mental states of other individuals assessed using the Hinting Test


Secondary Outcome Measures:
  • Anxiety [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Change from baseline to 6 month assessment in anxiety assessed using the Beck Anxiety Inventory

  • Depression [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Change from baseline to 6 month assessment in depression assessed using the Beck Depression Inventory

  • Psychosis [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Change from baseline to 6 month assessment in severity of positive and negative psychotic symptoms assessed using the Positive and Negative Syndrome Scale

  • Social Functioning [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Change from baseline to 6 month assessment in level of social functioning assessed using the Social Functioning Scale

  • Service Utilization [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Change from baseline to 6 month assessment in utilization of medical services assessed using the Service Utilization Record Form

  • Self-Determination Needs Satisfaction [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Change from baseline to 6 month assessment in ability to fulfill basic needs for autonomy, competence, and relatedness assessed using the Basic Psychological Needs Scale

  • Locus of Control [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Change from baseline to 6 month assessment in perception of one's ability to control events in the environment assessed using the Multidimensional Locus of Control Scale

  • Cognitive representation of illness [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Change from baseline to 6 month assessment in understanding of nature of psychotic illness assessed using the Illness Perception Questionnaire

  • Emotional Awareness [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Change from baseline to 6 month assessment in awareness of one's own emotions as well as emotions of others assessed using the Levels of Emotional Awareness Scale

  • Mindfulness [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Change from baseline to 6 month assessment in awareness and acceptance of feelings and events assessed using the Philadelphia Mindfulness Scale

  • Medication adherence [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Change from baseline to 6 month assessment in adherence to psychiatric medication assessed using the Medication Adherence Rating Scale

  • Neuropsychological functioning [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Change from baseline to 6 month assessment in neuropsychological functioning assessed using the MATRICS Consensus Cognitive Battery

  • Social Support [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Change from baseline to 6 month assessment in level of social support assessed using the Measure of Perceived Support

  • Illness Uncertainty [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Change from baseline to 6 month assessment in uncertainty with regard to cause, course, and treatment of illness assessed using the Mischel Uncertainty in Illness Scale

  • Relationship with familial caregivers [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Change from baseline to 6 month assessment in relationship with familial caregivers assessed using the Perception of Parents Scale

  • Self-efficacy [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Change from baseline to 6 month assessment in confidence with regard to control of psychotic symptoms assessed using the Self-Efficacy Scale for Schizophrenia

  • Experience of Stigma [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Change from baseline to 6 month assessment in experience of stigma with regard to mental illness assessed using the Stigma Questionnaire

  • quality of life [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Change from baseline to 6 month assessment in quality of life assessed using the WHO Quality of Life Scale-Brief

  • stage of recovery [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Change from baseline to 6 month assessment in stage of recovery with regard to mental illness assessed using the Stages of Recovery Instrument

  • Coping skills [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Change from baseline to 6 month assessment in level of coping skills assessed using the Ways of Coping Questionnaire

  • Time perspective [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Change from baseline to 6 month assessment in time orientation assessed using the Zimbardo Time Perspective Instrument


Estimated Enrollment: 110
Study Start Date: November 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Individuals with Longstanding Psychosis
Individuals with symptoms of psychosis that have been present for 5 or more years

Detailed Description:

There is growing evidence that individuals with longstanding psychotic disorders suffer from deficits in social cognition (i.e., the cognitive skills needed to successfully navigate social interactions). However, to date, there have been few attempts to measure multiple components of social cognition within the same population of individuals with psychosis. Thus, the interrelationships between various aspects of social cognition remain unclear. In the current study, the investigators propose to measure the five domains of social cognition identified by NIMH as relevant to individuals with psychosis (i.e., theory of mind, attribution style, emotion recognition, social perception, and social knowledge). The investigators will also explore the association between different domains of social cognition and outcomes relevant to psychotic disorder (e.g., symptomatology, social functioning, and vocational functioning).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Individuals with longstanding psychotic disorder (i.e., 5 years or longer in duration)

Criteria

Inclusion Criteria:

  • Diagnosis of a schizophrenia spectrum disorder or an affective disorder with psychotic features per the Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revised (DSM-IV-TR) criteria using the Structured Clinical Interview for the DSM-IV.
  • Duration of psychotic symptoms greater than or equal to 5 years determined using the Symptom Onset in Schizophrenia Inventory
  • Age 18-75
  • No evidence of mental retardation.
  • Able to provide informed consent as evidenced by passing the informed consent quiz with a score of 80% or greater.
  • Fluent in English as assessed per self-report from participant

Exclusion Criteria:

  • Unwilling or unable to complete study assessments (e.g., unable to read self-report questionnaires)
  • Subject is currently pregnant per subject's report
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01624831

Locations
United States, Arizona
University of Arizona Department of Psychiatry Recruiting
Tucson, Arizona, United States, 85724
Contact: Nicholas Breitborde, Ph.D.    520-874-7531      
Principal Investigator: Nicholas Breitborde, Ph.D.         
Sponsors and Collaborators
University of Arizona
Investigators
Principal Investigator: Nicholas Breitborde, Ph.D. University of Arizona
  More Information

No publications provided

Responsible Party: Nicholas Breitborde, Assistant Professor, Department of Psychiatry, University of Arizona
ClinicalTrials.gov Identifier: NCT01624831     History of Changes
Other Study ID Numbers: U. Az IRB 11-0567-02
Study First Received: November 7, 2011
Last Updated: February 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arizona:
Psychosis
schizophrenia
schizoaffective disorder
Bipolar disorder with psychotic features
Major depression with psychotic features
Psychosis NOS
Social Cognition

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Affective Disorders, Psychotic
Schizophrenia and Disorders with Psychotic Features
Bipolar Disorder
Depressive Disorder, Major
Depression
Depressive Disorder
Schizophrenia
Disease
Mood Disorders
Behavioral Symptoms
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014