Пилотное исследование Self-Help Plus, Колумбия: Train2Care (T2C)
Пилотное исследование "Self-Help Plus", Колумбия: Обучение заботе: Глобальное психическое здоровье с территориальным подходом
This project will strengthen local capacity for mental health care in high-need settings in Colombia by culturally and linguistically adapting the Self-Help+ intervention and delivering participatory, supervised training. Local community leaders will be trained to implement Self Help+ for their own well-being and to train others in their communities. The project will deliver a structured program with hands-on practice, ongoing technical support, and participatory evaluation of psychosocial outcomes and sustainability.
Обзор исследования
Подробное описание
The main goal of the project is to strengthen the mental health capacity of individuals living in low-income settings and community-based, public, and private organizations in Eastern Antioquia, Colombia, by culturally adapting the Self-Help+ intervention and piloting a participatory training program with key community actors, laying the groundwork for future scale-up and sustainability. The following are the objectives of the study:
- Culturally and linguistically adapt Self-Help+ to the local context of communities in Eastern Antioquia, Colombia
- Co-design a pilot training program on Self-Help+ delivery with key community actors using participatory methods
- Implement the pilot training program on Self-Help+ with the selected community actors using participatory approaches
- Conduct a preliminary mixed-methods evaluation of acceptability, feasibility, and early psychosocial outcome indicators
- Systematize implementation data to support knowledge sharing and ongoing technical monitoring of the strategies in critical contexts.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
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Antioquia
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Rionegro, Antioquia, Колумбия
- Universidad Catolica del Oriente
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- 18 years old and living in the study area
Exclusion Criteria:
- Current risk of self-harm or suicide that requires a higher level of care
- Significant cognitive impairment that would interfere with the ability to participate in the intervention or provide informed consent
- Severe mental health conditions requiring specialized care (for example, psychosis)
- Severe substance use or substance use disorders that would interfere with participation or require specialized treatment
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: Self Help Plus intervention
The Self Help Plus intervention is a five-session mental health support delivered to groups of up to 30 people. The Self-Help Plus supports the well-being of individuals facing adversity. This intervention is based on acceptance and commitment therapy and includes developing practical skills in grounding and present moment attention, mindful awareness, cognitive defusion, and valueclarification. |
Self-Help Plus is the World Health Organization's 5-session stress management course for large groups of up to 30 people. It is delivered by supervised, non-specialist facilitators who complete a short training course and use pre-recorded audio and an illustrated guide to teach stress management skills. The course is suitable for adults who experiences stress, wherever they live and whatever their circumstances. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Wellbeing - patient-defined mental health problems and functioning
Временное ограничение: Baseline
|
Psychological Outcome Profiles (PSYCHLOPS) is a patient-generated outcome measure designed to assess problems, functioning, and well-being from the participant's perspective. Total scores typically range from 0 to 20, with higher scores indicating worse psychological distress or poorer outcomes. |
Baseline
|
|
Wellbeing - patient-defined mental health problems and functioning
Временное ограничение: Immediately after the intervention
|
Psychological Outcome Profiles (PSYCHLOPS) is a patient-generated outcome measure designed to assess problems, functioning, and well-being from the participant's perspective. Total scores typically range from 0 to 20, with higher scores indicating worse psychological distress or poorer outcomes. |
Immediately after the intervention
|
|
Wellbeing - patient-defined mental health problems and functioning
Временное ограничение: 3 months follow-up
|
Psychological Outcome Profiles (PSYCHLOPS) is a patient-generated outcome measure designed to assess problems, functioning, and well-being from the participant's perspective. Total scores typically range from 0 to 20, with higher scores indicating worse psychological distress or poorer outcomes. |
3 months follow-up
|
|
WHO-5 Well-being Index
Временное ограничение: Baseline
|
The World Health Organization-Five Well-Being Index (WHO-5) is a 5-item measure of subjective psychological well-being. Raw total scores range from 0 to 25, with higher scores indicating better well-being. |
Baseline
|
|
WHO-5 Well-being Index
Временное ограничение: Immediately after the intervention
|
The World Health Organization-Five Well-Being Index (WHO-5) is a 5-item measure of subjective psychological well-being. Raw total scores range from 0 to 25, with higher scores indicating better well-being. |
Immediately after the intervention
|
|
WHO-5 Well-being Index
Временное ограничение: 3 months follow-up
|
The World Health Organization-Five Well-Being Index (WHO-5) is a 5-item measure of subjective psychological well-being. Raw total scores range from 0 to 25, with higher scores indicating better well-being. |
3 months follow-up
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Depression symptom severity
Временное ограничение: Baseline
|
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item measure of depressive symptom severity. Total scores range from 0 to 27, with higher scores indicating worse depressive symptoms. |
Baseline
|
|
Depression symptom severity
Временное ограничение: Immediately after the intervention
|
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item measure of depressive symptom severity. Total scores range from 0 to 27, with higher scores indicating worse depressive symptoms. |
Immediately after the intervention
|
|
Depression symptom severity
Временное ограничение: 3 months follow-up
|
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item measure of depressive symptom severity. Total scores range from 0 to 27, with higher scores indicating worse depressive symptoms. |
3 months follow-up
|
|
Generalized anxiety symptom severity
Временное ограничение: Baseline
|
The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item measure of anxiety symptom severity. Total scores range from 0 to 21, with higher scores indicating worse anxiety symptoms. |
Baseline
|
|
Generalized anxiety symptom severity
Временное ограничение: Immediately after the intervention
|
The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item measure of anxiety symptom severity. Total scores range from 0 to 21, with higher scores indicating worse anxiety symptoms. |
Immediately after the intervention
|
|
Generalized anxiety symptom severity
Временное ограничение: 3 months follow-up
|
The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item measure of anxiety symptom severity. Total scores range from 0 to 21, with higher scores indicating worse anxiety symptoms. |
3 months follow-up
|
Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Nathalia Rey Gómez, Universidad Catolica de Colombia
Публикации и полезные ссылки
Общие публикации
- Singla DR, Lawson A, Kohrt BA, Jung JW, Meng Z, Ratjen C, Zahedi N, Dennis CL, Patel V. Implementation and Effectiveness of Nonspecialist-Delivered Interventions for Perinatal Mental Health in High-Income Countries: A Systematic Review and Meta-analysis. JAMA Psychiatry. 2021 May 1;78(5):498-509. doi: 10.1001/jamapsychiatry.2020.4556.
- Patel V, Saxena S, Lund C, Thornicroft G, Baingana F, Bolton P, Chisholm D, Collins PY, Cooper JL, Eaton J, Herrman H, Herzallah MM, Huang Y, Jordans MJD, Kleinman A, Medina-Mora ME, Morgan E, Niaz U, Omigbodun O, Prince M, Rahman A, Saraceno B, Sarkar BK, De Silva M, Singh I, Stein DJ, Sunkel C, UnUtzer J. The Lancet Commission on global mental health and sustainable development. Lancet. 2018 Oct 27;392(10157):1553-1598. doi: 10.1016/S0140-6736(18)31612-X. Epub 2018 Oct 9. No abstract available.
- Self Help Plus (SH+): a group-based stress management course for adults. Generic field-trial version 1.0, 2021. Geneva: World Health Organization; 2021 (Series on low-intensity psychological interventions, No. 5). Licence: CC BY-NC-SA 3.0 IGO.
- The Self-Help Plus (SH+) training manual: for training facilitators to deliver the SH+ course. Geneva: World Health Organization; 2024. Licence: CC BY-NC-SA 3.0 IGO.
- Chisholm D, Sweeny K, Sheehan P, Rasmussen B, Smit F, Cuijpers P, Saxena S. Scaling-up of treatment of depression and anxiety - Authors' reply. Lancet Psychiatry. 2016 Jul;3(7):603-4. doi: 10.1016/S2215-0366(16)30131-6. No abstract available.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- NCR267175
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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