INTREPID - Deepening and Broadening knowledge of Psychoses Globally
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Medical Research Council
- Enrollment
- 1,441
- Locations
- 1
- Primary Endpoint
- Predictors of medium term course and outcome of psychoses; psychopathology; living situations; physical health; interpersonal relationships
Study Overview
Brief Summary
INTREPID is a programme on the epidemiology of Psychoses in three sites in the Global South (India, Nigeria, Trinidad). With INTREPID, our ultimate, ambitious goal is to transform our knowledge of and responses to psychotic disorders globally. We plan to achieve this by (1) delivering novel research programmes on medium-term course and outcomes, homeless populations, and putative mechanisms of risk and relapse, and (2) implementing a structured set of activities in each setting to ensure findings inform the development, and ultimately testing, of bespoke interventions. Our programme will be guided by our lived experience teams in each setting. We wish to examine the underlying mechanisms and processes involved in varying presentations, higher rates, poorer outcomes, and patterns of physical health and mortality. Three putative mechanisms are of particular interest that may mediate and constitute the pathways between risks and the onset and outcome of psychoses: (1) stress sensitivity; (2) cognitive function; and (3) accelerated aging. We have fixed the cohort sample size in each site to be between 200 and 220. And an additional 20 cases and 20 controls experiencing homelessness will be recruited to help us identify the pathways to homelessness. Quantitative research method is used to understand how the course of psychoses and other outcomes differ between the sites. Qualitative research method is used to examine the profiles and needs of individuals with a psychotic disorder who are homeless and to examine pathways into homelessness in each setting. Appropriate statistical analysis methods will be used to analyse the collected data. The overall outcomes are the predictors of course of psychoses and how it affects living situations, interpersonal relationships, physical health, cognitive functioning, etc. with this study we expect to deepen and broaden our understandings of psychotic disorders and to inform the development of locally relevant humane, accessible, and effective services.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 64.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Inclusion criteria for people with psychosis (“casesâ€):
- •Age 18 to 64 years at the start of the case-finding period
- •Currently resident in catchment area (primary residence)
- •Presence of ICD-11 psychotic disorder, including substance-induced psychoses.
- •Not treated with antipsychotic medication for more than one continuous month prior to the start of initial case identification Inclusion criteria for relatives:
- •Age 18 and above
- •Relative of an individual with a psychotic disorder who has consented to participate in the current study (either first-degree relative or other family member involved in care of the participating individual) Inclusion criteria for controls:
- •Age 18 to 64 years
- •Resident in catchment area (primary residence).
Exclusion Criteria
- •Exclusion criteria for people with psychosis (“casesâ€):
- •Transient psychotic symptoms resulting from acute intoxication as defined by ICD- 11
- •Moderate or severe learning disability, as defined by ICD-11
- •Clinically manifest organic cerebral disorder (e.g. infections, parasitic, toxic, cerebrovascular, epilepsy, brain injury), as defined by ICD-11 Exclusion criteria for relatives:
- •Insufficient contact with case to provide information on family burden or psychiatric history Exclusion criteria for controls:
- •Past or current ICD-10 psychotic disorder
- •Transient psychotic symptoms due to acute intoxication as defined by ICD-11
- •Clinically manifest organic cerebral disorder (e.g. infections, parasitic, toxic, cerebrovascular, epilepsy, brain injury), as defined by ICD-11
- •Related to the matched case.
Outcomes
Primary Outcomes
Predictors of medium term course and outcome of psychoses; psychopathology; living situations; physical health; interpersonal relationships
Time Frame: 2 year
Stress Sensitivity; Mood and Behaviour
Time Frame: 2 year
Cognitive Functioning
Time Frame: 2 year
Accelerated Aging
Time Frame: 2 year
Secondary Outcomes
- Pathways to homelessness; Help-seeking behaviour(2 year)
Investigators
Dr Thara Rangaswamy
Schizophrenia Research Foundation, India