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

Clinical High Risk for Psychosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04444180
• Other study ID #: CRC2018YB01
• Status: Completed
• Start date: July 6, 2019
• Est. completion date: November 30, 2021

Study information

• Verified date: January 2023
• Source: Shanghai Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Clinical High Risk for Psychosis
• Mental Disorders
• Psychotic Disorders

Intervention

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.

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View Citation

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, Zier — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. do — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavioral indicators	To compare the behavioral performance in VHI experimental paradigm among the three groups of CHR, FES, and HC	Baseline
Primary	Predictive indicators	To analyze the predictive role of self-representation in transition of CHR into psychosis	One-year follow-up node
Secondary	Resting-state brain functional connectivity (FC)	To observe the relationship of the behavioral performance in VHI experimental paradigm with the Resting-state brain functional connectivity	Baseline
Secondary	Event-related potential technique	To observe the relationship of the behavioral performance in VHI experimental paradigm with the error-related negativity	Baseline
Secondary	Neurocognitive function	To observe the relationship of the behavioral performance in VHI experimental paradigm with the neurocognitive functions	Baseline
Secondary	Other predictive indicators	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