We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Social Cognition in Longstanding Psychosis

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01624831
Recruitment Status : Terminated (Lack of funding)
First Posted : June 21, 2012
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Schizophrenia Schizoaffective Disorder Bipolar Disorder With Psychotic Features Major Depression With Psychotic Features Psychosis Not Otherwise Specified (NOS)

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).

Study Design

Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Social Cognition in Longstanding Psychosis
Study Start Date : November 2011
Primary Completion Date : November 2015
Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Individuals with Longstanding Psychosis
Individuals with symptoms of psychosis that have been present for 5 or more years


Outcome Measures

Primary Outcome Measures :
  1. Emotion Recognition [ Time Frame: Baseline and 6 months ]
    Change from baseline to 6 month assessment in ability to recognize emotions displayed by others assessed using the Facial Emotion Identification Test

  2. Attribution Style [ Time Frame: Baseline and 6 months ]
    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

  3. Social Perception [ Time Frame: Baseline and 6 months ]
    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

  4. Social Knowledge [ Time Frame: Baseline and 6 months ]
    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

  5. Theory of Mind [ Time Frame: Baseline and 6 months ]
    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 :
  1. Anxiety [ Time Frame: Baseline and 6 months ]
    Change from baseline to 6 month assessment in anxiety assessed using the Beck Anxiety Inventory

  2. Depression [ Time Frame: Baseline and 6 months ]
    Change from baseline to 6 month assessment in depression assessed using the Beck Depression Inventory

  3. Psychosis [ Time Frame: Baseline and 6 months ]
    Change from baseline to 6 month assessment in severity of positive and negative psychotic symptoms assessed using the Positive and Negative Syndrome Scale

  4. Social Functioning [ Time Frame: Baseline and 6 months ]
    Change from baseline to 6 month assessment in level of social functioning assessed using the Social Functioning Scale

  5. Service Utilization [ Time Frame: Baseline and 6 months ]
    Change from baseline to 6 month assessment in utilization of medical services assessed using the Service Utilization Record Form

  6. Self-Determination Needs Satisfaction [ Time Frame: Baseline and 6 months ]
    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

  7. Locus of Control [ Time Frame: Baseline and 6 months ]
    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

  8. Cognitive representation of illness [ Time Frame: Baseline and 6 months ]
    Change from baseline to 6 month assessment in understanding of nature of psychotic illness assessed using the Illness Perception Questionnaire

  9. Emotional Awareness [ Time Frame: Baseline and 6 months ]
    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

  10. Mindfulness [ Time Frame: Baseline and 6 months ]
    Change from baseline to 6 month assessment in awareness and acceptance of feelings and events assessed using the Philadelphia Mindfulness Scale

  11. Medication adherence [ Time Frame: Baseline and 6 months ]
    Change from baseline to 6 month assessment in adherence to psychiatric medication assessed using the Medication Adherence Rating Scale

  12. Neuropsychological functioning [ Time Frame: Baseline and 6 months ]
    Change from baseline to 6 month assessment in neuropsychological functioning assessed using the MATRICS Consensus Cognitive Battery

  13. Social Support [ Time Frame: Baseline and 6 months ]
    Change from baseline to 6 month assessment in level of social support assessed using the Measure of Perceived Support

  14. Illness Uncertainty [ Time Frame: Baseline and 6 months ]
    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

  15. Relationship with familial caregivers [ Time Frame: Baseline and 6 months ]
    Change from baseline to 6 month assessment in relationship with familial caregivers assessed using the Perception of Parents Scale

  16. Self-efficacy [ Time Frame: Baseline and 6 months ]
    Change from baseline to 6 month assessment in confidence with regard to control of psychotic symptoms assessed using the Self-Efficacy Scale for Schizophrenia

  17. Experience of Stigma [ Time Frame: Baseline and 6 months ]
    Change from baseline to 6 month assessment in experience of stigma with regard to mental illness assessed using the Stigma Questionnaire

  18. quality of life [ Time Frame: Baseline and 6 months ]
    Change from baseline to 6 month assessment in quality of life assessed using the WHO Quality of Life Scale-Brief

  19. stage of recovery [ Time Frame: Baseline and 6 months ]
    Change from baseline to 6 month assessment in stage of recovery with regard to mental illness assessed using the Stages of Recovery Instrument

  20. Coping skills [ Time Frame: Baseline and 6 months ]
    Change from baseline to 6 month assessment in level of coping skills assessed using the Ways of Coping Questionnaire

  21. Time perspective [ Time Frame: Baseline and 6 months ]
    Change from baseline to 6 month assessment in time orientation assessed using the Zimbardo Time Perspective Instrument


Eligibility Criteria

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 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT01624831


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

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
First Posted: June 21, 2012    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017

Keywords provided by Nicholas Breitborde, 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:
Disease
Depression
Schizophrenia
Bipolar Disorder
Psychotic Disorders
Mental Disorders
Depressive Disorder, Major
Pathologic Processes
Behavioral Symptoms
Schizophrenia Spectrum and Other Psychotic Disorders
Bipolar and Related Disorders
Depressive Disorder
Mood Disorders