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

NCT ID: NCT04444180

Last Updated: 2023-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-06

Study Completion Date

2021-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Clinical High Risk for Psychosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Virtual hand illusion (VHI)

Intervention Type DIAGNOSTIC_TEST

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.

Virtual hand illusion (VHI)

Intervention Type DIAGNOSTIC_TEST

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.

Virtual hand illusion (VHI)

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

11 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai Mental Health Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jijun Wang, Doctoral

Role: STUDY_CHAIR

Shanghai Mental Health Center

Tianhong Zhang, Doctoral

Role: STUDY_DIRECTOR

Shanghai Mental Health Center

Locations

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Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 29804931 (View on PubMed)

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.

Reference Type RESULT
PMID: 27374147 (View on PubMed)

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.

Reference Type RESULT
PMID: 14656496 (View on PubMed)

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.

Reference Type RESULT
PMID: 18411059 (View on PubMed)

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.

Reference Type RESULT
PMID: 29036731 (View on PubMed)

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.

Reference Type RESULT
PMID: 23273611 (View on PubMed)

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.

Reference Type RESULT
PMID: 26719911 (View on PubMed)

Other Identifiers

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CRC2018YB01

Identifier Type: -

Identifier Source: org_study_id

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