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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Arizona

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 21, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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