Using Speech to Monitor Symptom Severity in Arabic Speaking Patients With Schizophrenia

Monitoring Symptoms Severity in Arabic Speaking Schizophrenic Patients Using Mobile Phone Speech Analysis: A Proof-of-Concept Study

Brief Summary:

Definition: A short description of the clinical study, including a brief statement of the clinical study's hypothesis, written in language intended for the lay public.

Limit: 5000 characters. The purpose of this study is to investigate the relationship between speech features and severity of positive and negative clinical symptoms in Arabic speaking patients with schizophrenia. Individuals will be invited to participate in this study because (1) they have a confirmed clinical diagnosis of schizophrenia; (2) they plan to receive routine clinical care for schizophrenia at one of the four participating sites; (3) they speak Arabic as a first language.

Participants must be between the ages of 18-65 years. Participation will involve seven visits consisting of one baseline visit and six monthly follow-up visits. All participants will continue to receive routine clinical care.

Participation in this research will involve providing speech samples using standardized tasks collected using an electronic device. Additionally, study team members will assess positive and negative symptoms of schizophrenia using validated questionnaires.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Other: WinterLight Mobile Phone Speech Analysis

Detailed Description

Speech disorganization is a key feature of schizophrenia. The development of computerized tools to assess speech disorganization is rapidly growing in schizophrenia research. Several early studies showed that changes in speech distinguish schizophrenia patients from healthy controls and assist in differential diagnostics and relapse prevention (1). The Winterlight app can be used for speech collection and assessment and uses speech-based artificial intelligence to identify vocal biomarkers capable of detecting changes in cognitive/clinical symptoms.

Symptom rating scales remain the primary mode of assessing the nature and severity of schizophrenia and the magnitude of any change over time. The Positive and Negative Symptom Scale (PANSS) is a 30-item rating scale that was developed to measure the symptom severity of patients with schizophrenia and assess their dimensions (2). It has been widely used in clinical trials of schizophrenia and is considered as the "gold standard" for the assessment of antipsychotic treatment efficacy.

The goal of this study is to test the hypothesis that quantitative measures derived from speech samples acquired using the Winterlight application will be associated with positive and negative symptom subscores as assessed by the PANSS.

The investigators will use speech-based artificial intelligence methods to identify aspects of voice and language that are related to schizophrenia symptoms in Arabic-speaking patients.

Data collected may be used to evaluate:

1. The relationship between speech measures and PANSS subscores at baseline.
2. The relationship between changes in speech measures and changes in positive symptoms over time.
3. The relationship between changes in speech measures and changes in negative symptoms over time.
4. The ability for speech measures to be used to predict psychotic relapse in individuals with schizophrenia.
5. The feasibility of predicting relapse based on speech and sociodemographic variables.

• Study Type: Observational
• Enrollment (Actual): 57

Contacts and Locations

• Study Contact: Name: Ruba Jaber; Phone Number: 11663 009625805430; Email: rjaber@hikma.com
• Study Contact Backup: Name: Amal Al-Tabba; Phone Number: 11661 009625805430; Email: aaltabba@hikma.com

Study Locations

• Algeria
  • Algiers, Algeria
    • Mustapha University Hospital
• Egypt
  • Cairo, Egypt
    • Ain Shams Hospital
• Jordan
  • Amman, Jordan
    • Mental Health Hub
• Saudi Arabia
  • Jeddah, Saudi Arabia
    • Jeddah Psychiatry Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from four medical sites in the Middle East North Africa (MENA) region, which are located in Jordan, Saudi Arabia, Egypt, and Algeria.

Description

Inclusion Criteria:

1. Aged 18 - 65 years
2. Confirmed clinical diagnosis of schizophrenia as per the DSM-5 criteria, at any stage of disease.
3. Planned to receive routine clinical care for schizophrenia in the study site for the next 6 months.
4. Arabic is first language

Exclusion Criteria:

1. Illiterate.
2. Catatonic schizophrenia subtype.
3. Neurological disorder or major health problem.
4. Severe substance use disorder using DSM-5 criteria.
5. Risk to self or others.
6. Patient with any speech disorder or treated/planned to be treated with any medication known to impact speech (e.g. first-generation antipsychotics)
7. Patient or family member is unable to provide consent to participate in the study.
8. Participation in another clinical study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Arabic-speaking individuals with schizophrenia; Approximately 56-60 Arabic-speaking individuals with a DSM-5 diagnosis of schizophrenia	Other: WinterLight Mobile Phone Speech Analysis; N/A- observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech features derived from the Winterlight Assessment (WLA).	Acoustic and linguistic measures of speech acquired using the Winterlight Application	up to month 6
Positive and Negative Syndrome Scale (PANSS) including total score, positive subscore, negative subscore and psychopathology subscore.	30-item clinical scale to assess positive and negative symptoms severity in people with schizophrenia.	up to month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in speech features derived from the Winterlight Assessment (WLA).	Baseline to endpoint (6 month) change on acoustic and linguistic measures of speech computed based on the WLA.	Change from baseline to month 6
Change in Positive and Negative Syndrome Scale (PANSS) including total score, positive subscore, negative subscore and psychopathology subscore. score measured by the PANSS positive sub-score	Baseline to endpoint (6 month) change on 30-item clinical scale to assess positive and negative symptoms severity in people with schizophrenia	Change from baseline to month 6
Incidence of psychotic relapse	Psychotic relapse is defined as: hospitalization, suicidal/homicidal ideation, violent behavior, a 25% increase in the PANSS total score, or a significant increase in at least one of several pre-specified PANSS items.	Change from baseline to month 6

Collaborators and Investigators

• Sponsor: Hikma Pharmaceuticals LLC
• Collaborators: Winterlight Labs

Publications and helpful links

General Publications

• Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261.
• de Boer JN, Brederoo SG, Voppel AE, Sommer IEC. Anomalies in language as a biomarker for schizophrenia. Curr Opin Psychiatry. 2020 May;33(3):212-218. doi: 10.1097/YCO.0000000000000595.

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2021
• Primary Completion (Actual): December 20, 2022
• Study Completion (Actual): December 20, 2022

Study Registration Dates

• First Submitted: March 8, 2022
• First Submitted That Met QC Criteria: September 28, 2022
• First Posted (Actual): October 3, 2022

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Schizophrenia; Language; Mental Disorders; Speech; Natural Language Processing; Behavioral Symptoms; Schizophrenic Disorders; Voice
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: HIK-WL-SCZ-2021-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No