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临床试验/CTRI/2024/03/064449
CTRI/2024/03/064449尚未招募不适用

INTREPID - Deepening and Broadening knowledge of Psychoses Globally

Medical Research Council1 个研究点 分布在 1 个国家目标入组 1,441 人开始时间: 2024年6月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,441
试验地点
1
主要终点
Predictors of medium term course and outcome of psychoses; psychopathology; living situations; physical health; interpersonal relationships

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 64.00 Year(s)(—)
性别
All

入选标准

  • Inclusion criteria for people with psychosis (“cases”):
  • 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).

排除标准

  • Exclusion criteria for people with psychosis (“cases”):
  • 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.

结局指标

主要结局

Predictors of medium term course and outcome of psychoses; psychopathology; living situations; physical health; interpersonal relationships

时间窗: 2 year

Stress Sensitivity; Mood and Behaviour

时间窗: 2 year

Cognitive Functioning

时间窗: 2 year

Accelerated Aging

时间窗: 2 year

次要结局

  • Pathways to homelessness; Help-seeking behaviour(2 year)

研究者

申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Thara Rangaswamy

Schizophrenia Research Foundation, India

研究点 (1)

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