PsychosisBASISNCT06042712
Belief-updating, Speech and Psychosis
An observational study of Psychosis, run by King's College London.
Trial summary
Psychotic illnesses are characterised by hallucinations, delusions, and disturbed thoughts; symptoms associated with high personal and societal costs. Despite the efficacy of antipsychotic medication, approximately 84% of patients experience at least one relapse within 36 months of their first episode. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Psychosis
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 30 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 40 years
- All sexes
- Adult
Study population: People with a first episode of psychosis and matched controls
Who may be able to join
- Participants will be recruited from two routes:
- Participants who are part of Urban Mind study will be invited to the present study;
- Patients who are referred to the following early psychosis teams will also be invited to the study: Lambeth Early Psychosis (LEO), Southwark Team for Early Psychosis (STEP), Lewisham Early Intervention Service (LEIS), Croydon Outreach Assessment Support Team (COAST), Central and North West London NHS Foundation Trust (NWLFT).
- Participants from both routes will need to meet the following criteria:
- all participants are 18 to 40 years old
- all participants have an adequate command of the English language to complete the assessment
- all participants need access to laptop, smartphone or computer to complete the tasks
- all participants met FEP as defined by a DSM-IV diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, or delusional disorder based on the Structured Clinical Interview for DSM-IV (SCID-I) (First et al., 2002).
Who cannot join
- Experienced more than one previous episode of psychosis
- Any other neurological disorders that could potentially interfere with study process or patients' safety
- Refusing to complete the belief-updating or speech tasks
- Participants' answers are identified as fake answers or participants complete the tasks for multiple times (identified by their unique participants code).
- Participants are unable to fully comprehend the purpose of the study or make a rational decision whether or not to participate
About this study
Official title: Belief-updating and Speech: Potential Markers of Psychosis Relapse
Psychotic illnesses are characterised by hallucinations, delusions, and disturbed thoughts; symptoms associated with high personal and societal costs. Despite the efficacy of antipsychotic medication, approximately 84% of patients experience at least one relapse within 36 months of their first episode. Thus, identifying patients who will relapse and who will not, and then providing specific treatment to patients who are more likely to relapse is clinically meaningful. Belief-updating and speech are promising markers to predict first episode psychosis (FEP) patients future relapse outcome, as there has been evidence linking these two markers with the onset and progression of psychotic symptoms.
The present study will collect cognitive measures relating to belief-updating and speech in patients with FEP at baseline, and build models to predict relapse based on these measures. Belief updating tasks include simple video games (escaping from a planet in the Space Task and a reversal learning task). To collect speech, participants will be asked to describe ambiguous pictures. The study uses a naturalistic follow-up design; data will be collected from 140 FEP patients recruited from local clinical teams and 100 healthy controls recruited from advertisements. Cognitive tasks will be conducted via an online platform Gorilla using participants' own device (e.g. computer, laptop, smartphone and tablet). Clinical interviews can take place either online or face-to-face. Participants will attend three assessments in total, at baseline and at 6-month and 12-month follow-up. Each visit will comprise two components 1) cognitive tasks (45-60 minutes) and basic demographics, 2) clinical interviews.
- Conditions
- Psychosis
- Medical subject headings
- Psychotic Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse
Change in score on the Positive and Negative Syndrome Scale
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start1 May 2024 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by King's College LondonThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042712
- Sponsor's protocol ID
- IRAS 323994
- Acronym
- BASIS
- Status last verified
- Mar 2024
- First submitted
- 8 Sep 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Belief-updating and Speech: Potential Markers of Psychosis Relapse
- ClinicalTrials.gov ID
- NCT06042712
- Acronym / sponsor ID
- BASIS / IRAS 323994
- Conditions
- Psychosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 18 Sep 2023 (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.
Psychotic illnesses are characterised by hallucinations, delusions, and disturbed thoughts; symptoms associated with high personal and societal costs. Despite the efficacy of antipsychotic medication, approximately 84% of patients experience at least one relapse within 36 months of their first episode. Thus, identifying patients who will relapse and who will not, and then providing specific treatment to patients who are more likely to relapse is clinically meaningful. Belief-updating and speech are promising markers to predict first episode psychosis (FEP) patients future relapse outcome, as there has been evidence linking these two markers with the onset and progression of psychotic symptoms.
The present study will collect cognitive measures relating to belief-updating and speech in patients with FEP at baseline, and build models to predict relapse based on these measures. Belief updating tasks include simple video games (escaping from a planet in the Space Task and a reversal learning task). To collect speech, participants will be asked to describe ambiguous pictures. The study uses a naturalistic follow-up design; data will be collected from 140 FEP patients recruited from local clinical teams and 100 healthy controls recruited from advertisements. Cognitive tasks will be conducted via an online platform Gorilla using participants' own device (e.g. computer, laptop, smartphone and tablet). Clinical interviews can take place either online or face-to-face. Participants will attend three assessments in total, at baseline and at 6-month and 12-month follow-up. Each visit will comprise two components 1) cognitive tasks (45-60 minutes) and basic demographics, 2) clinical interviews.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Age groups
- Adult
- Study population
- People with a first episode of psychosis and matched controls
Key inclusion criteria (8 listed)
- Participants who are part of Urban Mind study will be invited to the present study;
- Patients who are referred to the following early psychosis teams will also be invited to the study: Lambeth Early Psychosis (LEO), Southwark Team for Early Psychosis (STEP), Lewisham Early Intervention Service (LEIS), Croydon Outreach Assessment Support Team (COAST), Central and North West London NHS Foundation Trust (NWLFT).
- all participants are 18 to 40 years old
- all participants have an adequate command of the English language to complete the assessment
- all participants need access to laptop, smartphone or computer to complete the tasks
Key exclusion criteria (5 listed)
- Experienced more than one previous episode of psychosis
- Any other neurological disorders that could potentially interfere with study process or patients' safety
- Refusing to complete the belief-updating or speech tasks
- Participants' answers are identified as fake answers or participants complete the tasks for multiple times (identified by their unique participants code).
- Participants are unable to fully comprehend the purpose of the study or make a rational decision whether or not to participate
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
Relapse
Time frame: One year
Change in score on the Positive and Negative Syndrome Scale
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychosis, run by King's College London.
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 8 inclusion and 5 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: opening soon, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Relapse (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2024.