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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01624831
Other study ID # U. Az IRB 11-0567-02
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date November 2011
Est. completion date November 2015

Study information

Verified date May 2020
Source University of Arizona
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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).


Recruitment information / eligibility

Status Terminated
Enrollment 9
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Arizona Department of Psychiatry Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Emotion Recognition Change from baseline to 6 month assessment in ability to recognize emotions displayed by others assessed using the Facial Emotion Identification Test Baseline and 6 months
Primary Attribution Style 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 Baseline and 6 months
Primary Social Perception 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 Baseline and 6 months
Primary Social Knowledge 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 Baseline and 6 months
Primary Theory of Mind Change from baseline to 6 month assessment in ability to identify the mental states of other individuals assessed using the Hinting Test Baseline and 6 months
Secondary Anxiety Change from baseline to 6 month assessment in anxiety assessed using the Beck Anxiety Inventory Baseline and 6 months
Secondary Depression Change from baseline to 6 month assessment in depression assessed using the Beck Depression Inventory Baseline and 6 months
Secondary Psychosis Change from baseline to 6 month assessment in severity of positive and negative psychotic symptoms assessed using the Positive and Negative Syndrome Scale Baseline and 6 months
Secondary Social Functioning Change from baseline to 6 month assessment in level of social functioning assessed using the Social Functioning Scale Baseline and 6 months
Secondary Service Utilization Change from baseline to 6 month assessment in utilization of medical services assessed using the Service Utilization Record Form Baseline and 6 months
Secondary Self-Determination Needs Satisfaction 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 Baseline and 6 months
Secondary Locus of Control 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 Baseline and 6 months
Secondary Cognitive representation of illness Change from baseline to 6 month assessment in understanding of nature of psychotic illness assessed using the Illness Perception Questionnaire Baseline and 6 months
Secondary Emotional Awareness 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 Baseline and 6 months
Secondary Mindfulness Change from baseline to 6 month assessment in awareness and acceptance of feelings and events assessed using the Philadelphia Mindfulness Scale Baseline and 6 months
Secondary Medication adherence Change from baseline to 6 month assessment in adherence to psychiatric medication assessed using the Medication Adherence Rating Scale Baseline and 6 months
Secondary Neuropsychological functioning Change from baseline to 6 month assessment in neuropsychological functioning assessed using the MATRICS Consensus Cognitive Battery Baseline and 6 months
Secondary Social Support Change from baseline to 6 month assessment in level of social support assessed using the Measure of Perceived Support Baseline and 6 months
Secondary Illness Uncertainty 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 Baseline and 6 months
Secondary Relationship with familial caregivers Change from baseline to 6 month assessment in relationship with familial caregivers assessed using the Perception of Parents Scale Baseline and 6 months
Secondary Self-efficacy Change from baseline to 6 month assessment in confidence with regard to control of psychotic symptoms assessed using the Self-Efficacy Scale for Schizophrenia Baseline and 6 months
Secondary Experience of Stigma Change from baseline to 6 month assessment in experience of stigma with regard to mental illness assessed using the Stigma Questionnaire Baseline and 6 months
Secondary quality of life Change from baseline to 6 month assessment in quality of life assessed using the WHO Quality of Life Scale-Brief Baseline and 6 months
Secondary stage of recovery Change from baseline to 6 month assessment in stage of recovery with regard to mental illness assessed using the Stages of Recovery Instrument Baseline and 6 months
Secondary Coping skills Change from baseline to 6 month assessment in level of coping skills assessed using the Ways of Coping Questionnaire Baseline and 6 months
Secondary Time perspective Change from baseline to 6 month assessment in time orientation assessed using the Zimbardo Time Perspective Instrument Baseline and 6 months
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