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Идёт набор NCT05852314

A Problem-Solving Intervention for Women With Suicidal Ideation During Postnatal Period in Pakistan

Без фазы С лечением Postnatal Depression

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: Culturally Adapted Manual Assisted Therapy (CMAP-SI).
Кому может быть актуально
Состояния в реестре: Postnatal Depression. Базовые параметры: 16 лет — 44 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
Пакистан
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Culturally Adapted Manual-Assisted Problem-Solving Intervention for Women With Suicidal Ideation in Postnatal Period in Pakistan: A Feasibility Trial

Обзор

The aim of this study is to determine the feasibility and acceptability of culturally adapted CMAP for suicidal Ideation for women in postnatal period. Objectives 1. To adapt existing CMAP Intervention for suicidal ideation (CMAP-SI) in postnatal period. 2. To investigate whether CMAP-SI is feasible and acceptable among women presenting suicidal Ideations in postnatal period; and 3. To test whether there is an indication for the effects of the CMAP in reducing suicidal thoughts among women in postnatal period. 4. To explore participants experiences with CMAP-SI Intervention.

Подробное описание

Suicide is a major public health concern globally, affecting not only the individuals but also family members and society through increased resource costs and productivity loss. Although suicides and suicide attempts occur at a lower rate during pregnancy and the postpartum period than in general population, the prevalence of suicidal thoughts during these periods ranges from 5-14% worldwide and this may result in suicide attempts and completions. There is a growing evidence suggesting that suicidal thoughts and behaviour among women in postnatal period in Low-and Middle-Income Countries (LMICs) are comparable to postnatal women in high resource settings. For instance, in observational studies based on hospital samples of women in postnatal period, 11% women had suicidal behaviour (i.e., thoughts and attempts) in Pakistan, 14% in Ethiopia and 13.6% in Nepal. The causes of these high prevalence rates point to the underlying maternal health issues such as antenatal depression and common mental disorders such as anxiety and depression. Evidence based interventions exists in prevention, care and treatment of suicidal thoughts such as Cognitive Behavioural Therapy (CBT). To deliver a CBT based intervention in Pakistani context, Husain and colleagues tailored a treatment manual: "Life after Self-Harm" to the general population in Pakistan. This Culturally Adapted Manual Assisted Problem solving (CMAP) aims at suicide prevention by reducing the probability of self-harm. Pakistan being a low resource setting faces a huge challenge to provide health care to its population. Therefore, it is important to screen women in postnatal period for risk for suicidal thoughts and behaviour, as well as, the maternal health problems. It is equally important to deliver culturally sensitive interventions which are addressing the psycho-social context wherein suicidal behaviour occurs. Thus, the main aim of this study is to determine the feasibility and acceptability of culturally adapted CMAP for suicidal Ideation for women in postnatal period.

Вмешательства

  • Поведенческое Culturally Adapted Manual Assisted Therapy (CMAP-SI)
    C-MAP has been adapted from a self-help guide called Life After Self-Harm based on the principles of CBT. It is a brief problem-solving therapy comprising have 4 sessions weekly and then 4 fortnightly and last about 50 minutes each. The manual has been translated to Urdu giving special consideration to cultural adaptation of phrases and concepts to reflect Pakistani culture. Additionally, culturally appropriate case scenarios were incorporated and a consensual view to addressing cultural factors

Первичные конечные точки

  • Feasibility and Acceptability [Срок оценки: At 3 months after baseline]
Вторичные конечные точки (7)
  • Beck Scale for Suicidal Ideation (BSS) (Beck et al., 1988) [Срок оценки: Baseline and 3 months]
  • Suicide Attempt and Self-Harm (SASH) (Eylem, 2011) [Срок оценки: Baseline and 3 months]
  • Edinburgh postnatal depression scale (EPDS) (Cox et al., 1987) [Срок оценки: Baseline and 3 months]
  • Beck Depression Inventory (BDI) (Beck et al., 1961) [Срок оценки: Baseline and 3 months]
  • Life Events Checklist (Husain et al., 2000) [Срок оценки: Baseline and 3 months]
  • Oslo- 3 Social Support Scale (O3SSS) (Dalgard, 2009) [Срок оценки: Baseline and 3 months]
  • Euro Quol (EQ-5D) (Rabin & Charro, 2001) [Срок оценки: Baseline and 3 months]

Критерии участия

Критерии включения

  • 16 to 44-year-old mothers with children 0 - 30 months old
  • Residents of the trial site catchments area
  • Able to provide informed consent
  • Presenting with suicidal ideation as measured by the Beck Suicidal Ideation Scale (BSSI) (must score 1 or 2 on item 4 and 5)
  • Not requiring in-patient psychiatric treatment.

Критерии исключения

We will exclude mothers with any physical or psychiatric condition severe enough to prevent study participation.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Другое

Центры проведения

Пакистан · 1 центр
  • Benazir Bhutto Hospital — Rawalpindi

Идентификаторы

NCT: NCT05852314 · CMAP- PNSI

Первоисточники (государственные реестры)

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