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Идёт набор NCT05485701

Perinatal Mental Health Study (PMHS) India

— Наблюдательное Depression Anxiety Suicidal Ideation Somatization

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Screening tools for common mental disorders.
Кому может быть актуально
Состояния в реестре: Depression, Anxiety, Suicidal Ideation, Somatization. Базовые параметры: 18 лет — 45 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Индия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Perinatal Mental Health Study (PMHS): a Cohort and Validation Study in Two Low-income Settings in India

Обзор

The purpose of this observational study is to improve understanding of mental disorders among perinatal women in India.

Подробное описание

The purpose of this observational study is to assess the mental health of perinatal women living in two low-income settings in India. The first phase will explore women's awareness of mental illness and acceptability of screening for mental disorders. The second phase will be a validation study, during which the psychometric properties of screening tools will be assessed against a gold standard. The third stage will comprise a cohort study, during which the prevalence of and risk factors for mental disorders among perinatal and non-perinatal women will be established.

Вмешательства

  • Диагностический тест Screening tools for common mental disorders
    A number of screening tools will be administered which will establish the likelihood of depression, anxiety, PTSD, somatisation and suicidality.

Первичные конечные точки

  • Phase 1: Codes and themes relating to acceptability of screening for perinatal mental disorders [Срок оценки: To be completed by August 2022]
  • Phase 2: Psychometric properties of screening tools for common mental disorders [Срок оценки: September 2022 - August 2023]
  • Phase 3: Point prevalence, period prevalence and incidence (with 95% confidence intervals) of common mental disorders among perinatal and non-perinatal women [Срок оценки: September 2023 - August 2024]
  • Phase 3: Odds ratios (with 95% confidence intervals) for factors associated with common mental disorders among perinatal and non-perinatal women [Срок оценки: September 2023 - August 2024]

Критерии участия

Критерии включения

For Phase 1 (qualitative study) and Phase 2 (validation study):

Pregnant women:

  • Aged 18 to 45 years
  • Currently pregnant (any trimester)
  • Willing and able to give informed consent

Post-partum women:

  • Aged 18 to 45 years
  • Currently post-partum (between 1-12 months postpartum)
  • Willing and able to give informed consent

Non-perinatal women:

  • Aged 18 to 45 years
  • Not currently pregnant and not given birth in the past 12 months
  • Willing and able to give informed consent

For Phase 3 (prospective cohort study):

Perinatal women:

  • Aged 18 to 45 years
  • In early pregnancy (estimated gestational age <20 weeks) at recruitment
  • Not planning to relocate for the duration of the study period
  • Willing and able to give informed consent
  • Expressed a willingness to continue to participate for the four planned visits

Non-perinatal women:

  • Aged 18 to 45 years
  • Not currently pregnant and not given birth in the last 12 months
  • Not planning to relocate for the duration of the study period
  • Willing and able to give informed consent
  • Expressed a willingness to continue to participate for the four planned visits

Критерии исключения

The participant may not enter the study if:

  • They have an acutely severe psychiatric illness which impairs their ability to take part in the study
  • They are not willing or able to provide informed consent

Other than for current severe psychiatric illness which affects ability to participate in the study, we will not exclude any participant on the basis of current or prior physical, psychological or psychiatric co-morbidities so long as she is willing to participate, her ability to take part is not compromised and her ability to give informed consent is not impaired by these conditions.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Индия · 2 центра
  • Dr Rajendra Prasad Government Medical College — Kangra
  • National Institute of Mental Health and Neuro Sciences — Bengaluru

Публикации

  • Fellmeth G, Kishore MT, Verma A, Desai G, Bharti O, Kanwar P, Singh S, Thippeswamy H, Chandra PS, Kurinczuk JJ, Nair M, Alderdice F. Perinatal mental health in India: protocol for a validation and cohort study. J Public Health (Oxf). 2021 Oct 8;43(Suppl 2):ii35-ii42. doi: 10.1093/pubmed/fdab162. PMID 34622290
  • Fellmeth G, Sharma D, Kanwar P, Chawla K, Gupta V, Thakur A, Harrison S, Quigley MA, Bharti O, Chandra PS, Desai G, Thippeswamy H, Singh S, Nair M, Kishore MT, Alderdice F, Verma A; Perinatal Mental Health Study (PMHS) Group. Identifying common mental disorders among perinatal and non-perinatal women in northern India: a cross-sectional validation study of the diagnostic accuracy of six self-repor PMID 41857859

Идентификаторы

NCT: NCT05485701 · 10-20

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗