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SchizophreniaNCT01624831

Social Cognition in Longstanding Psychosis

An observational study of Schizophrenia and Schizoaffective Disorder, run by University of Arizona at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 75 years
How many people
9 participants
Where
1 siteUnited States
Study dates
Nov 2011to Nov 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Arizona Department of Psychiatry

    Tucson, Arizona, 85724

Other trials in United States

About this study

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).

Read the 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).

Keywords
Psychosis, schizophrenia, schizoaffective disorder, Bipolar disorder with psychotic features, Major depression with psychotic features, Psychosis NOS, Social Cognition
Medical subject headings
Schizophrenia, Psychotic Disorders, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01624831
Study groupRoleWhat they receive
Individuals with Longstanding PsychosisIndividuals with symptoms of psychosis that have been present for 5 or more years

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Emotion Recognition

    Change from baseline to 6 month assessment in ability to recognize emotions displayed by others assessed using the Facial Emotion Identification Test

    Measured: Baseline and 6 months

  2. 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

    Measured: Baseline and 6 months

  3. 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

    Measured: Baseline and 6 months

  4. 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

    Measured: Baseline and 6 months

  5. 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

    Measured: Baseline and 6 months

Secondary outcomes (21)

  1. Anxiety

    Change from baseline to 6 month assessment in anxiety assessed using the Beck Anxiety Inventory

    Measured: Baseline and 6 months

  2. Depression

    Change from baseline to 6 month assessment in depression assessed using the Beck Depression Inventory

    Measured: Baseline and 6 months

  3. Psychosis

    Change from baseline to 6 month assessment in severity of positive and negative psychotic symptoms assessed using the Positive and Negative Syndrome Scale

    Measured: Baseline and 6 months

  4. Social Functioning

    Change from baseline to 6 month assessment in level of social functioning assessed using the Social Functioning Scale

    Measured: Baseline and 6 months

  5. Service Utilization

    Change from baseline to 6 month assessment in utilization of medical services assessed using the Service Utilization Record Form

    Measured: Baseline and 6 months

  6. 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

    Measured: Baseline and 6 months

  7. 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

    Measured: Baseline and 6 months

  8. Cognitive representation of illness

    Change from baseline to 6 month assessment in understanding of nature of psychotic illness assessed using the Illness Perception Questionnaire

    Measured: Baseline and 6 months

  9. 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

    Measured: Baseline and 6 months

  10. Mindfulness

    Change from baseline to 6 month assessment in awareness and acceptance of feelings and events assessed using the Philadelphia Mindfulness Scale

    Measured: Baseline and 6 months

  11. Medication adherence

    Change from baseline to 6 month assessment in adherence to psychiatric medication assessed using the Medication Adherence Rating Scale

    Measured: Baseline and 6 months

  12. Neuropsychological functioning

    Change from baseline to 6 month assessment in neuropsychological functioning assessed using the MATRICS Consensus Cognitive Battery

    Measured: Baseline and 6 months

  13. Social Support

    Change from baseline to 6 month assessment in level of social support assessed using the Measure of Perceived Support

    Measured: Baseline and 6 months

  14. 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

    Measured: Baseline and 6 months

  15. Relationship with familial caregivers

    Change from baseline to 6 month assessment in relationship with familial caregivers assessed using the Perception of Parents Scale

    Measured: Baseline and 6 months

  16. 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

    Measured: Baseline and 6 months

  17. Experience of Stigma

    Change from baseline to 6 month assessment in experience of stigma with regard to mental illness assessed using the Stigma Questionnaire

    Measured: Baseline and 6 months

  18. quality of life

    Change from baseline to 6 month assessment in quality of life assessed using the WHO Quality of Life Scale-Brief

    Measured: Baseline and 6 months

  19. 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

    Measured: Baseline and 6 months

  20. Coping skills

    Change from baseline to 6 month assessment in level of coping skills assessed using the Ways of Coping Questionnaire

    Measured: Baseline and 6 months

  21. Time perspective

    Change from baseline to 6 month assessment in time orientation assessed using the Zimbardo Time Perspective Instrument

    Measured: Baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2012 (estimated)
  2. Study startNov 2011
  3. Primary completionNov 2015
  4. Study completionNov 2015

Why it stopped: Lack of funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01624831
Sponsor's protocol ID
U. Az IRB 11-0567-02
Status last verified
May 2020
First submitted
7 Nov 2011
Last updated
21 May 2020
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Schizophrenia and Schizoaffective Disorder, run by University of Arizona at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Lack of funding). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Emotion Recognition (time frame: Baseline and 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01624831.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2020.

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