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

NCT04444180 | Completed DMC

• 1 other identifier: CRC2018YB01
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Clinical High Risk for Psychosis

Keywords

sense of ownership; sense of agency; virtual hand illusion

Outcome Measures

Primary Outcomes (2)

• Behavioral indicators

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

  Baseline

• Predictive indicators

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

  One-year follow-up node

Secondary Outcomes (4)

• Resting-state brain functional connectivity (FC)

  Baseline

• Event-related potential technique

  Baseline

• Neurocognitive function

  Baseline

• Other predictive indicators

  One-year follow-up node

Study Arms (3)

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)

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)

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)

Interventions

Virtual hand illusion (VHI) DIAGNOSTIC_TEST

Using VHI, the two basic self-representation of sense of ownership and sense of agency of the subjects will be observed.

Clinical high risk for psychosis (CHR); First episode of schizophrenia (FES); Healthy control (HC)

Eligibility Criteria

• Age: 11 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

Related Publications (7)

• Raballo A, Monducci E, Ferrara M, Fiori Nastro P, Dario C; RODIN group. Developmental vulnerability to psychosis: Selective aggregation of basic self-disturbance in early onset schizophrenia. Schizophr Res. 2018 Nov;201:367-372. doi: 10.1016/j.schres.2018.05.012. Epub 2018 May 25.

  PMID: 29804931 RESULT

• Ebisch SJH, Aleman A. The fragmented self: imbalance between intrinsic and extrinsic self-networks in psychotic disorders. Lancet Psychiatry. 2016 Aug;3(8):784-790. doi: 10.1016/S2215-0366(16)00045-6. Epub 2016 Jun 30.

  PMID: 27374147 RESULT

• Newen A, Vogeley K. Self-representation: searching for a neural signature of self-consciousness. Conscious Cogn. 2003 Dec;12(4):529-43. doi: 10.1016/s1053-8100(03)00080-1.

  PMID: 14656496 RESULT

• Synofzik M, Vosgerau G, Newen A. I move, therefore I am: a new theoretical framework to investigate agency and ownership. Conscious Cogn. 2008 Jun;17(2):411-24. doi: 10.1016/j.concog.2008.03.008. Epub 2008 Apr 14.

  PMID: 18411059 RESULT

• Shaqiri A, Roinishvili M, Kaliuzhna M, Favrod O, Chkonia E, Herzog MH, Blanke O, Salomon R. Rethinking Body Ownership in Schizophrenia: Experimental and Meta-analytical Approaches Show no Evidence for Deficits. Schizophr Bull. 2018 Apr 6;44(3):643-652. doi: 10.1093/schbul/sbx098.

  PMID: 29036731 RESULT

• Germine L, Benson TL, Cohen F, Hooker CI. Psychosis-proneness and the rubber hand illusion of body ownership. Psychiatry Res. 2013 May 15;207(1-2):45-52. doi: 10.1016/j.psychres.2012.11.022. Epub 2012 Dec 28.

  PMID: 23273611 RESULT

• Fusar-Poli P, Cappucciati M, Borgwardt S, Woods SW, Addington J, Nelson B, Nieman DH, Stahl DR, Rutigliano G, Riecher-Rossler A, Simon AE, Mizuno M, Lee TY, Kwon JS, Lam MM, Perez J, Keri S, Amminger P, Metzler S, Kawohl W, Rossler W, Lee J, Labad J, Ziermans T, An SK, Liu CC, Woodberry KA, Braham A, Corcoran C, McGorry P, Yung AR, McGuire PK. Heterogeneity of Psychosis Risk Within Individuals at Clinical High Risk: A Meta-analytical Stratification. JAMA Psychiatry. 2016 Feb;73(2):113-20. doi: 10.1001/jamapsychiatry.2015.2324.

  PMID: 26719911 RESULT

Study Officials

• Jijun Wang, Doctoral

  Shanghai Mental Health Center

  STUDY CHAIR

• Tianhong Zhang, Doctoral

  Shanghai Mental Health Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2020
• First Posted: June 23, 2020
• Study Start: July 6, 2019
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: January 23, 2023

Record last verified: 2023-01

Locations

CN (1)