Belief-updating, Speech and Psychosis (BASIS)

March 4, 2024 updated by: King's College London

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

240

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

People with a first episode of psychosis and matched controls

Description

Inclusion Criteria:

Inclusion criteria (FEP)

Participants will be recruited from two routes:

  1. Participants who are part of Urban Mind study will be invited to the present study;
  2. 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).

Exclusion Criteria:

Exclusion criteria (FEP)

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relapse
Time Frame: One year
Change in score on the Positive and Negative Syndrome Scale
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

April 30, 2028

Study Registration Dates

First Submitted

September 8, 2023

First Submitted That Met QC Criteria

September 15, 2023

First Posted (Actual)

September 18, 2023

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRAS 323994

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe