- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01624831
Social Cognition in Longstanding Psychosis
May 19, 2020 updated by: Nicholas Breitborde, University of Arizona
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).
Study Overview
Status
Terminated
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 Type
Observational
Enrollment (Actual)
9
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Tucson, Arizona, United States, 85724
- University of Arizona Department of Psychiatry
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Individuals with longstanding psychotic disorder (i.e., 5 years or longer in duration)
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Individuals with Longstanding Psychosis
Individuals with symptoms of psychosis that have been present for 5 or more years
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline and 6 months
|
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
|
Baseline and 6 months
|
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
|
Baseline and 6 months
|
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
|
Baseline and 6 months
|
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
|
Baseline and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety
Time Frame: Baseline and 6 months
|
Change from baseline to 6 month assessment in anxiety assessed using the Beck Anxiety Inventory
|
Baseline and 6 months
|
Depression
Time Frame: Baseline and 6 months
|
Change from baseline to 6 month assessment in depression assessed using the Beck Depression Inventory
|
Baseline and 6 months
|
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
|
Baseline and 6 months
|
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
|
Baseline and 6 months
|
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
|
Baseline and 6 months
|
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
|
Baseline and 6 months
|
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
|
Baseline and 6 months
|
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
|
Baseline and 6 months
|
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
|
Baseline and 6 months
|
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
|
Baseline and 6 months
|
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
|
Baseline and 6 months
|
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
|
Baseline and 6 months
|
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
|
Baseline and 6 months
|
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
|
Baseline and 6 months
|
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
|
Baseline and 6 months
|
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
|
Baseline and 6 months
|
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
|
Baseline and 6 months
|
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
|
Baseline and 6 months
|
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
|
Baseline and 6 months
|
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
|
Baseline and 6 months
|
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
|
Baseline and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Actual)
November 1, 2015
Study Completion (Actual)
November 1, 2015
Study Registration Dates
First Submitted
November 7, 2011
First Submitted That Met QC Criteria
June 18, 2012
First Posted (Estimate)
June 21, 2012
Study Record Updates
Last Update Posted (Actual)
May 21, 2020
Last Update Submitted That Met QC Criteria
May 19, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- U. Az IRB 11-0567-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Schizophrenia
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Bradley LegaRecruiting
-
All India Institute of Medical Sciences, BhubaneswarRecruitingTreatment Resistant SchizophreniaIndia
-
King's College LondonSouth London and Maudsley NHS Foundation TrustRecruitingTreatment-resistant Schizophrenia | Healthy Controls | Treatment-responsive SchizophreniaUnited Kingdom
-
University of Sao PauloUnknownRefractory Schizophrenia | Super Refractory SchizophreniaBrazil
-
Ohio State UniversityRecruitingTreatment-resistant SchizophreniaUnited States
-
University Hospital, BrestRecruitingSchizophrenia | Schizophrenia Prodromal | Schizophrenia, ChildhoodFrance
-
NYU Langone HealthNot yet recruitingTreatment-resistant SchizophreniaUnited States
-
Johns Hopkins UniversityNational Institute of Mental Health (NIMH)RecruitingTreatment-resistant SchizophreniaUnited States