NCT01624831

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2011

Completed
8 months until next milestone

First Posted

Study publicly available on registry

June 21, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

May 21, 2020

Status Verified

May 1, 2020

Enrollment Period

4 years

First QC Date

November 7, 2011

Last Update Submit

May 19, 2020

Conditions

SchizophreniaSchizoaffective DisorderBipolar Disorder With Psychotic FeaturesMajor Depression With Psychotic FeaturesPsychosis Not Otherwise Specified (NOS)

Keywords

Psychosisschizophreniaschizoaffective disorderBipolar disorder with psychotic featuresMajor depression with psychotic featuresPsychosis NOSSocial Cognition

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (21)

  • Anxiety

    Baseline and 6 months

  • Depression

    Baseline and 6 months

  • Psychosis

    Baseline and 6 months

  • Social Functioning

    Baseline and 6 months

  • Service Utilization

    Baseline and 6 months

  • +16 more secondary outcomes

Study Arms (1)

Individuals with Longstanding Psychosis

Individuals with symptoms of psychosis that have been present for 5 or more years

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Unwilling or unable to complete study assessments (e.g., unable to read self-report questionnaires)
  • Subject is currently pregnant per subject's report

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arizona Department of Psychiatry

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersMental Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

  • Nicholas Breitborde, Ph.D.

    The Ohio State Univerity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Psychiatry

Study Record Dates

First Submitted

November 7, 2011

First Posted

June 21, 2012

Study Start

November 1, 2011

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

May 21, 2020

Record last verified: 2020-05

Locations

US(1)