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

Sponsor
Shanghai Mental Health Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04444180
Collaborator
(none)
160
1
28.8
5.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Virtual hand illusion (VHI)

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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
160 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
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
Actual Study Start Date :
Jul 6, 2019
Anticipated Primary Completion Date :
Nov 30, 2021
Anticipated Study Completion Date :
Nov 30, 2021

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Behavioral indicators [Baseline]

    To compare the behavioral performance in VHI experimental paradigm among the three groups of CHR, FES, and HC

  2. Predictive indicators [One-year follow-up node]

    To analyze the predictive role of self-representation in transition of CHR into psychosis

Secondary Outcome Measures

  1. Resting-state brain functional connectivity (FC) [Baseline]

    To observe the relationship of the behavioral performance in VHI experimental paradigm with the Resting-state brain functional connectivity

  2. Event-related potential technique [Baseline]

    To observe the relationship of the behavioral performance in VHI experimental paradigm with the error-related negativity

  3. Neurocognitive function [Baseline]

    To observe the relationship of the behavioral performance in VHI experimental paradigm with the neurocognitive functions

  4. Other predictive indicators [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
11 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai Mental Health Center Shanghai Shanghai China 200030

Sponsors and Collaborators

  • Shanghai Mental Health Center

Investigators

  • Study Chair: Jijun Wang, Doctoral, Shanghai Mental Health Center
  • Study Director: Tianhong Zhang, Doctoral, Shanghai Mental Health Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai Mental Health Center
ClinicalTrials.gov Identifier:
NCT04444180
Other Study ID Numbers:
  • CRC2018YB01
First Posted:
Jun 23, 2020
Last Update Posted:
Sep 20, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shanghai Mental Health Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 20, 2021