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Набор скоро начнётся NCT06980441

Culturally Adapted Psychological Support for Conflict-Affected Afghans: Study Protocol on Mental Health & Violence

Без фазы С лечением Depression and Suicide Ideation Anxiety PTSD

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: Problem Management Plus with Emotional Processing module.
Кому может быть актуально
Состояния в реестре: Depression and Suicide Ideation, Anxiety, PTSD. Базовые параметры: 16 лет — 30 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Afghanistan
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Feasibility and Acceptability of Culturally Adapted, Evidence-Informed Psychological Support on Mental Health Symptoms and Violence for Conflict-Affected Populations in Afghanistan: A Study Protocol

Обзор

This pilot study examines the feasibility and acceptability of a culturally adapted psychological intervention-Problem Management Plus with Emotional Processing (PM+ EP)-for young Afghans aged 16-30 experiencing high psychological distress. Through a pilot randomized control trial and qualitative interviews, the study explores whether PM+ EP can reduce symptoms of anxiety, depression, PTSD, and aggression, and improve daily functioning. Findings will inform the potential for a larger trial and address critical mental health and violence prevention needs in conflict-affected Afghan communities.

Подробное описание

Background: A large portion of Afghanistan's population, particularly children, has endured prolonged conflict, poverty, and displacement, leading to significant psychological distress. As children grow into adolescence and adulthood, this distress often manifests in mental health symptoms and an increased likelihood of violent behaviours. With limited mental health professionals and strong stigma around mental health in Afghanistan, culturally adapted, evidence-based interventions are needed.

Objective: The study aims to explore the feasibility and acceptability of culturally adapted mental health intervention Problem Management Plus with an additional Emotional Processing module (PM+ EP), in reducing psychological distress in young Afghans. The primary objective is to assess the feasibility of delivering this intervention in Afghanistan and its acceptability by the target communities, and the secondary objective is to assess symptom reduction and behavioural change.

Methods: This is a pilot Randomized Control Trial (RCT) with participants aged 16 to 30 in Afghanistan. Eligible participants, young Afghans with high levels of distress and impaired functioning - measured by the Kessler Psychological Distress Scale (K10) -, will be randomized to PM+ EP (n=30) or the waiting group (n=30). The participants will be evaluated through self-report questionnaires at three time points; baseline (T1), four weeks later immediately post-intervention (T2), and 3 months post-intervention (T3), and through a qualitative interview (Process Evaluation) at the end of the study. Outcomes will include measures of anxiety and depression (HSCL-25), aggressive behaviours (AGQ), PTSD symptoms (PCL-5), and daily functioning (WHODAS 2.0).

Analysis: This study will assess the feasibility and acceptability of culturally adapted PM+ EP in Afghanistan and explore the relationship between mental health symptoms and violence among young Afghans. It will be the first to evaluate the feasibility of PM+ EP with this population and could pave the way for a large define RCT examining the effectiveness this approach, should the results show promise.

Вмешательства

  • Поведенческое Problem Management Plus with Emotional Processing module
    PM+ EP comprises of Problem Management Plus, an evidence-based low intensity psychological intervention developed by the World Health Organization (WHO), with an additional Emotional Processing module specifically to address psychological distress related to trauma exposure. The core of the intervention is designed for adults impaired by distress in communities exposed to conflict and adversity; it consists of CBT techniques that have been adapted for communities that do not have good availabili

Первичные конечные точки

  • Reduction in psychological distress symptoms among participants, as measured by scientific scale HSCL-25. [Срок оценки: Pre-intervention until 3 months post-intervention]
  • Reduction in psychological distress symptoms among participants, as measured by scientific scale DSM-5 (PCL-5). [Срок оценки: Pre-intervention until 3 months post-intervention]
  • Reduction in psychological distress symptoms among participants, as measured by scientific scale WHODAS 2.0. [Срок оценки: Pre-intervention until 3 months post-intervention]
Вторичные конечные точки (2)
  • Participant-Reported Changes in Attitudes Toward Violence and Perceived Impact of PM+ EP on Mental Health and Behavior. [Срок оценки: 3 months post-intervention]
  • Analysis of relationship between mental health and violence, as measured by scientific scale AGQ. [Срок оценки: Pre-intervention until 3 months post-intervention]

Критерии участия

Критерии включения

  • Psychological Distress, measured at >15 on the Kessler Psychological Distress Scale (K10)
  • Afghan nationality
  • Age between 16 and 30
  • Ability to read and write in Dari

Критерии исключения

  • Imminent suicide risk
  • Experiencing psychosis
  • Neurological or cognitive disabilities

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Другое

Центры проведения

Afghanistan · 1 центр
  • Peace of Mind Association (PoMA) — Kabul

Идентификаторы

NCT: NCT06980441 · 1378139

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗