The Predictive Role of Self-representation in Transition of Individuals at Clinical High Risk for Psychosis

January 19, 2023 updated by: Shanghai Mental Health Center

The Predictive Role of Self Representation in Transition of Individuals at Clinical High Risk for Psychosis -- a Study on the Clinical Application of Virtual Hand Illusion

Schizophrenia is one of the most consumptive diseases, which brings great loss to patients and their families, and even to the society. Clinical High Risk for Psychosis (CHR) is a concept put forward on the basis of the prodromal stage of schizophrenia. Over the past 20 years, the identification and intervention of CHR has become the focus of psychiatric research, with the primary goal of early identification of biomarkers of susceptibility to schizophrenia and the development of individualized interventions to prevent or delay progression. Longitudinal studies have shown that CHR converted to schizophrenia mainly within two years, with a risk of about 30 percent. Self-disorder is one of the core characteristics of schizophrenia. The two most basic experiences of self-representation are sense of ownership and sense of agency. Sense of ownership refers to the sense that "I" perceives "my" body, while sense of agency refers to the sense that "I" experiences "my" actions and their consequences are initiated by "me". Some studies have shown that patients with schizophrenia show defects in the sense of ownership and agency. The most commonly used paradigm for observing "sense of ownership" and "sense of agency" is the rubber hand illusion (RHI) or the virtual hand illusion (VHI). In this study, the VHI experimental paradigm will be used to detect the self-representation of the individuals at high risk for psychosis, and the clinical outcome will be observed for one year.The hypothesis is that the subjects who exhibit abnormal illusion experience in VHI experiment are more likely to transition into psychotic disorders.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is conducted according to the tenets of the Declaration of Helsinki. All participants are recruited at the Shanghai Mental Health Center (SMHC) or its affiliate, the Shanghai Psychotherapy and Psychological Counseling Center (SPCC) with written informed consent, approved by the Research Ethics Committee of SMHC. For those younger than 18 years, both the adolescents and their next of kin or legal guardians are provided informed consents. The outpatients are recommended by doctors to participate in our CHR screening. After being screened and interviewed, those who meet the inclusion criteria are informed and signed written informed consent. Once the subjects are recruited, clinical evaluation, VHI and MCCB test will be conducted. In addition, CHR individuals will be followed up at one-year node.

Study Type

Observational

Enrollment (Actual)

160

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

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Shanghai Mental Health Center

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

11 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study mainly observe the behavioral representation and its predictive role in transition outcome of CHR individuals, who meeting the criteria of psychosis-risk syndromes (COPS) for the existence of one or more of psychosis high risk syndromes, such as brief intermittent psychotic syndrome (BIPS), attenuated positive symptom syndrome (APSS), and genetic risk and deterioration syndrome (DRDS).

Description

Inclusion Criteria:

  • For CHR individuals, meet the criteria of psychosis-risk syndromes after rating by structured interview for psychosis high risk syndrome.
  • For FES patients, meet diagnostic criteria for schizophrenia in the DSM-IV.
  • For HC individuals, gender composition, age range, educational level are matched with CHR individuals.
  • Understand and sign written informed consent.

Exclusion Criteria:

  • For CHR individuals, exclude individuals with other axis I or II mental disorders, which can explain the abnormal experience.
  • For CHR and FES patients, exclude those patients taking antipsychotics for more than two weeks.
  • For HC individuals, exclude those with family history of mental disorders
  • With a history of substance dependence.
  • Use of medications that may affect mental and cognitive functions.
  • With central nervous system disorder, that cuase symptoms or interfere with judgment.
  • Traumatic brain injury score is 7 or more.
  • With serious or unstable physical diseases.
  • With perceptual developmental disorders.
  • IQ<70.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Clinical high risk for psychosis (CHR)
No intervention. Just use virtual hand illusion (VHI) paradigm to observe the outcome of individuals with CHR at one-year follow-up node and analyze the predictive role of self-representation in transition into psychosis.
Diagnostic test: Virtual hand illusion (VHI)
Using VHI, the two basic self-representation of sense of ownership and sense of agency of the subjects will be observed.
First episode of schizophrenia (FES)
In contrast to FES, it is anticipated to observe CHR individuals with similar behavioral performance to FES may presented higher risk of transition.
Diagnostic test: Virtual hand illusion (VHI)
Using VHI, the two basic self-representation of sense of ownership and sense of agency of the subjects will be observed.
Healthy control (HC)
In contrast to HC, it is anticipated to observe CHR individuals with similar behavioral performance to HC may presented lower risk of transition.
Diagnostic test: Virtual hand illusion (VHI)
Using VHI, the two basic self-representation of sense of ownership and sense of agency of the subjects will be observed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behavioral indicators
Time Frame: Baseline
To compare the behavioral performance in VHI experimental paradigm among the three groups of CHR, FES, and HC
Baseline
Predictive indicators
Time Frame: One-year follow-up node
To analyze the predictive role of self-representation in transition of CHR into psychosis
One-year follow-up node

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resting-state brain functional connectivity (FC)
Time Frame: Baseline
To observe the relationship of the behavioral performance in VHI experimental paradigm with the Resting-state brain functional connectivity
Baseline
Event-related potential technique
Time Frame: Baseline
To observe the relationship of the behavioral performance in VHI experimental paradigm with the error-related negativity
Baseline
Neurocognitive function
Time Frame: Baseline
To observe the relationship of the behavioral performance in VHI experimental paradigm with the neurocognitive functions
Baseline
Other predictive indicators
Time Frame: One-year follow-up node
To analyze the predictive role of FC and neurocognitive functions related to self-representation in transition of CHR into psychosis
One-year follow-up node

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Mental Health Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

July 6, 2019

Primary Completion (Actual)

November 30, 2021

Study Completion (Actual)

November 30, 2021

Study Registration Dates

First Submitted

June 20, 2020

First Submitted That Met QC Criteria

June 20, 2020

First Posted (Actual)

June 23, 2020

Study Record Updates

Last Update Posted (Actual)

January 23, 2023

Last Update Submitted That Met QC Criteria

January 19, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRC2018YB01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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