SchizophreniaNCT04399096
Sound and Vision: A Collaboration Between Service-users, Artists and the Public to Explore the Lived Experience of Hallucinations
An observational study of Schizophrenia and Parkinson Disease, run by University of Cambridge at 2 sites in United Kingdom.
Trial summary
Sound and Vision: A collaboration between service-users, artists and the public to explore the lived experience of hallucinations Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Parkinson Disease, Hallucinations
- How many people
- 500 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Dec 2020to Dec 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The general publication attending an exhibition of artworks depicting the experience of hallucinations.
No particular inclusion or exclusion criteria
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Cambridge and Peterborough NHS Trust
Cambridge, Cambs
Emilio Fernandez-Egea, PhD, Emilio.Fernandez@cpft.nhs.uk
- Recruiting
Cambridge University Hospital
Cambridge, Cambs
James Rowe, PhD, James.Rowe@mrc-cbu.cam.ac.uk
About this study
Sound and Vision: A collaboration between service-users, artists and the public to explore the lived experience of hallucinations
Read the detailed description
Sound and Vision will pair local artists with patients who have had hallucinations to create art pieces that represent their hallucinatory experiences. Patients with diagnoses of schizophrenia and Parkinson's disease will be invited to take part in participating National Health Service (NHS) clinics, to capture and compare a wide range of hallucinatory experiences. Patients will meet with artists on several occasions who will then develop the piece, which may be a painting, drawing, or other media that the artist and service-user jointly select.
Completed artworks will be the centrepiece for an exhibition at United Kingdom (UK) science festivals and a digital (on-line) presentation. The exhibition will be accompanied by researchers explaining the brain science of hallucinations, recordings of patients and artists describing their experience with hallucinations and the process of developing the artworks, booklets cataloguing the exhibition, and art materials available for artistic expression of their own experiences. A digital compendium of the artworks and supporting material will be publicly available alongside the opportunity to complete an online survey exploring the themes of the artworks and collecting information on personal experiences. The objectives are to engage the public in an appreciation of the experience of hallucinations and their prevalence across many common mental health and neurodegenerative disorders, as well as an experience many people will share without ever being diagnosed. The exhibition will also encourage the public to share their own experiences through the online questionnaires creating a platform to begin to improve the understanding of the diversity of hallucination-like experiences in the general population.
- Conditions
- Schizophrenia, Parkinson Disease, Hallucinations
- Keywords
- hallucination
- Medical subject headings
- Schizophrenia, Parkinson Disease, Hallucinations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| General population | The general public attending exhibitions of the artworks who wish to complete the on-line questionnaire and feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
University of Miami Parkinson's disease Hallucinations Questionnaire (UM-PDHQ)
The University of Miami Parkinson's disease Hallucinations Questionnaire (UM-PDHQ) is composed of 6 quantitative and 14 qualitative items to define the key characteristics of hallucinations in Parkinson's Disease. The first 6 questions score the severity of hallucinations with a minimum score is zero and a maximum of 14, with greater score indicating greater severity. The remaining 14 questions have qualitative answers.
Measured: Through study completion, an average of 1 year
The Multi-Modality Unusual Sensory Experiences Questionnaire (MUSEQ)
The Multi-Modality Unusual Sensory Experiences Questionnaire (MUSEQ) is a 43-item self-report measure with each item rated on a five-point Likert scale, and assesses unusual sensory experiences in six modalities: auditory, visual, olfactory, gustatory, bodily sensations, and sensed presence. The minimum score is zero, the maximum score is 173 with a greater score indicating a higher frequency of unusual sensory experiences.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start1 Dec 2020
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust, Cambridgeshire and Peterborough NHS Foundation Trust
- Responsible party
- Principal investigator, John Suckling, University of Cambridge
- Investigators
- John Suckling, Principal investigator, University of CambridgeEmilio Fernandez-Egea, Principal investigator, Cambridgeshire and Peterborough NHS Foundation TrustJames Rowe, Principal investigator, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04399096
- Sponsor's protocol ID
- 269849
- Status last verified
- Apr 2021
- First submitted
- 13 May 2020
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rollins CPE, Garrison JR, Simons JS, Rowe JB, O'Callaghan C, Murray GK, Suckling J. Meta-analytic Evidence for the Plurality of Mechanisms in Transdiagnostic Structural MRI Studies of Hallucination Status. EClinicalMedicine. 2019 Feb 21;8:57-71. doi: 10.1016/j.eclinm.2019.01.012. eCollection 2019 Feb.
PubMed 31193632
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sound and Vision: A Collaboration Between Service-users, Artists and the Public to Explore the Lived Experience of Hallucinations
- ClinicalTrials.gov ID
- NCT04399096
- Acronym / sponsor ID
- 269849
- Conditions
- Schizophrenia, Parkinson Disease, Hallucinations
- Keywords
- hallucination
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust, Cambridgeshire and Peterborough NHS Foundation Trust
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 22 May 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.
Sound and Vision: A collaboration between service-users, artists and the public to explore the lived experience of hallucinations
Detailed description
Sound and Vision will pair local artists with patients who have had hallucinations to create art pieces that represent their hallucinatory experiences. Patients with diagnoses of schizophrenia and Parkinson's disease will be invited to take part in participating National Health Service (NHS) clinics, to capture and compare a wide range of hallucinatory experiences. Patients will meet with artists on several occasions who will then develop the piece, which may be a painting, drawing, or other media that the artist and service-user jointly select.
Completed artworks will be the centrepiece for an exhibition at United Kingdom (UK) science festivals and a digital (on-line) presentation. The exhibition will be accompanied by researchers explaining the brain science of hallucinations, recordings of patients and artists describing their experience with hallucinations and the process of developing the artworks, booklets cataloguing the exhibition, and art materials available for artistic expression of their own experiences. A digital compendium of the artworks and supporting material will be publicly available alongside the opportunity to complete an online survey exploring the themes of the artworks and collecting information on personal experiences. The objectives are to engage the public in an appreciation of the experience of hallucinations and their prevalence across many common mental health and neurodegenerative disorders, as well as an experience many people will share without ever being diagnosed. The exhibition will also encourage the public to share their own experiences through the online questionnaires creating a platform to begin to improve the understanding of the diversity of hallucination-like experiences in the general population.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General population | – | –The general public attending exhibitions of the artworks who wish to complete the on-line questionnaire and feedback |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The general publication attending an exhibition of artworks depicting the experience of hallucinations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
University of Miami Parkinson's disease Hallucinations Questionnaire (UM-PDHQ)
Time frame: Through study completion, an average of 1 year
The University of Miami Parkinson's disease Hallucinations Questionnaire (UM-PDHQ) is composed of 6 quantitative and 14 qualitative items to define the key characteristics of hallucinations in Parkinson's Disease. The first 6 questions score the severity of hallucinations with a minimum score is zero and a maximum of 14, with greater score indicating greater severity. The remaining 14 questions have qualitative answers.
The Multi-Modality Unusual Sensory Experiences Questionnaire (MUSEQ)
Time frame: Through study completion, an average of 1 year
The Multi-Modality Unusual Sensory Experiences Questionnaire (MUSEQ) is a 43-item self-report measure with each item rated on a five-point Likert scale, and assesses unusual sensory experiences in six modalities: auditory, visual, olfactory, gustatory, bodily sensations, and sensed presence. The minimum score is zero, the maximum score is 173 with a greater score indicating a higher frequency of unusual sensory experiences.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Background: PubMed 31193632Rollins CPE, Garrison JR, Simons JS, Rowe JB, O'Callaghan C, Murray GK, Suckling J. Meta-analytic Evidence for the Plurality of Mechanisms in Transdiagnostic Structural MRI Studies of Hallucination Status. EClinicalMedicine. 2019 Feb 21;8:57-71. doi: 10.1016/j.eclinm.2019.01.012. eCollection 2019 Feb.
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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.
John Suckling principal investigator
University of Cambridge
Emilio Fernandez-Egea principal investigator
Cambridgeshire and Peterborough NHS Foundation Trust
James Rowe principal investigator
Cambridge University Hospitals NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Parkinson Disease, run by University of Cambridge at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John Suckling (01223 336063, js369@cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
University of Miami Parkinson's disease Hallucinations Questionnaire (UM-PDHQ) (time frame: Through study completion, an average of 1 year). 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 NCT04399096, which also lists 1 linked publication.
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 28 Apr 2021.