Clinical High Risk for PsychosisNCT04444180
The Predictive Role of Self-representation in Transition of Individuals at Clinical High Risk for Psychosis
An observational study of Clinical High Risk for Psychosis, run by Shanghai Mental Health Center at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 11 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Clinical High Risk for Psychosis
- What is being tested?
- Virtual hand illusion (VHI)
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 6 Jul 2019to 30 Nov 2021
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- Traumatic brain injury score is 7 or more.
- With serious or unstable physical diseases.
- With perceptual developmental disorders.
- IQ<70.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
About this study
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
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.
Read the 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.
- Conditions
- Clinical High Risk for Psychosis
- Being tested
- Virtual hand illusion (VHI)
- Keywords
- sense of ownership, sense of agency, virtual hand illusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: Virtual hand illusion (VHI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral indicators
To compare the behavioral performance in VHI experimental paradigm among the three groups of CHR, FES, and HC
Measured: Baseline
Predictive indicators
To analyze the predictive role of self-representation in transition of CHR into psychosis
Measured: One-year follow-up node
Secondary outcomes (4)
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
Measured: Baseline
Event-related potential technique
To observe the relationship of the behavioral performance in VHI experimental paradigm with the error-related negativity
Measured: Baseline
Neurocognitive function
To observe the relationship of the behavioral performance in VHI experimental paradigm with the neurocognitive functions
Measured: Baseline
Other predictive indicators
To analyze the predictive role of FC and neurocognitive functions related to self-representation in transition of CHR into psychosis
Measured: One-year follow-up node
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start6 Jul 2019
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Clinical High Risk for PsychosisStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jijun Wang, Doctoral, Study chair, Shanghai Mental Health CenterTianhong Zhang, Doctoral, Study director, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04444180
- Sponsor's protocol ID
- CRC2018YB01
- Status last verified
- Jan 2023
- First submitted
- 20 Jun 2020
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29804931Ebisch 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.
PubMed 27374147Newen 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.
PubMed 14656496Synofzik 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.
PubMed 18411059Shaqiri 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.
PubMed 29036731Germine 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.
PubMed 23273611Fusar-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.
PubMed 26719911
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04444180
- Acronym / sponsor ID
- CRC2018YB01
- Conditions
- Clinical High Risk for Psychosis
- Keywords
- sense of ownership, sense of agency, virtual hand illusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 6 Jul 2019 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 23 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clinical high risk for psychosis (CHR) | – | Diagnostic Test: Virtual hand illusion (VHI)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. |
| First episode of schizophrenia (FES) | – | Diagnostic Test: Virtual hand illusion (VHI)In contrast to FES, it is anticipated to observe CHR individuals with similar behavioral performance to FES may presented higher risk of transition. |
| Healthy control (HC) | – | Diagnostic Test: Virtual hand illusion (VHI)In contrast to HC, it is anticipated to observe CHR individuals with similar behavioral performance to HC may presented lower risk of transition. |
Who may qualify
- Ages
- 11 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Clinical high risk for psychosis (CHR), First episode of schizophrenia (FES), Healthy control (HC) |
Primary outcome
Behavioral indicators
Time frame: Baseline
To compare the behavioral performance in VHI experimental paradigm among the three groups of CHR, FES, and HC
Predictive indicators
Time frame: One-year follow-up node
To analyze the predictive role of self-representation in transition of CHR into psychosis
4 secondary outcomes
Resting-state brain functional connectivity (FC)
Time frame: Baseline
Event-related potential technique
Time frame: Baseline
Neurocognitive function
Time frame: Baseline
Other predictive indicators
Time frame: One-year follow-up node
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Results publication: PubMed 29804931Raballo 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.
- Results publication: PubMed 27374147Ebisch 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.
- Results publication: PubMed 14656496Newen 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.
- Results publication: PubMed 18411059Synofzik 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.
- Results publication: PubMed 29036731Shaqiri 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.
- Results publication: PubMed 23273611Germine 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.
- Results publication: PubMed 26719911Fusar-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.
- Individual participant dataSharing planned: Undecided
Related trials for Clinical High Risk for Psychosis
Recruiting
Developing a Recovery-Oriented Suicide Prevention Program for Young People at Clinical High Risk for Psychosis
Clinical High Risk for Psychosis (CHR), Suicidal Ideation
Enrolling by invitationObservational study
Evaluation of Step-Based Care for Individuals at Clinical High Risk for Psychosis
Prodromal Schizophrenia
Not yet recruiting
Mobile Thinking Intervention: A Inital Test
Schizophrenia, Clinical High Risk for Psychosis (CHR)
Not yet recruitingPhase 3
Stratification and Treatment in Early Psychosis Study - PROMOTE
Clinical High Risk for Psychosis (CHR), Clinical High Risk for Psychosis
Recruiting
Reducing the Duration of Untreated Psychosis in the United States: The Impact of Screening and Systematic Communication
First Episode Psychosis (FEP), Clinical High Risk for Psychosis (CHR)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jijun Wang, Doctoral study chair
Shanghai Mental Health Center
Tianhong Zhang, Doctoral study director
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clinical High Risk for Psychosis, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral indicators (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04444180, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023.