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NCT Number: NCT04444180

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

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.

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Key information

Conditions

Clinical High Risk for Psychosis

Age range

11 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Behavioral indicators

    Time frame: Baseline

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

  2. Predictive indicators

    Time frame: One-year follow-up node

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

Secondary outcomes

  1. 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

  2. Event-related potential technique

    Time frame: Baseline

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

  3. Neurocognitive function

    Time frame: Baseline

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

  4. 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

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 23, 2020
Registry last updated
Jan 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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