Digital Lifestyle Intervention for Mental Health Among Migrants: Randomized Controlled Trial
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: Digital Lifestyle Intervention.
- Кому может быть актуально
- Состояния в реестре: Mental Health Disorder, Depression, Anxiety, Psychological Distress. Базовые параметры: от 18 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
- Список центров уточняется — проверьте первичный протокол.
- 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
Digital Lifestyle Intervention to Improve Mental Health Among Migrants: A Randomized Controlled Trial With a Nested Pilot Study
Обзор
Migrant populations experience elevated levels of psychological distress while facing barriers to accessing mental health care. Lifestyle factors such as physical activity, sleep, diet, and social engagement are closely linked to mental health and represent promising targets for preventive interventions. Digital delivery may increase accessibility and reduce structural barriers to care. The aim of this study is to evaluate the feasibility, acceptability, and efficacy of a culturally and linguistically adapted digital lifestyle intervention for migrants experiencing moderate psychological distress in Sweden. Participants (N = 240) will be randomized to an 8-week digital lifestyle intervention or to a wait-list control receiving a general lifestyle module. A nested pilot study (N = 30) will first assess feasibility and acceptability. Outcomes include general psychological health, quality of life, depression, anxiety, stress, and lifestyle behaviors. Assessments will be conducted at baseline, post-treatment (8 weeks), 2-month follow-up, and 6-month follow-up.
Подробное описание
Mental health disorders such as depression and anxiety are major contributors to the global burden of disease and are closely linked to lifestyle factors including physical inactivity, poor sleep, unhealthy diet, and substance use. Migrant populations report higher levels of psychological distress than the general population while simultaneously being less likely to seek mental health care due to structural and cultural barriers. This treatment gap highlights the need for accessible preventive interventions adapted to the needs of migrant populations.
Lifestyle interventions targeting physical activity, sleep, diet, and social engagement have shown promising effects in reducing symptoms of depression, anxiety, and stress. Delivering such interventions digitally offers advantages including scalability, cost-efficiency, and improved accessibility for populations facing barriers to traditional healthcare.
The present study will evaluate a culturally and linguistically adapted digital lifestyle intervention for migrants living in Sweden who experience moderate psychological distress. The intervention is delivered over eight weeks through a secure internet platform and includes psychoeducation and behavioral strategies based on cognitive behavioral therapy principles. Participants receive text-based guidance from trained psychologists.
The study will begin with a nested pilot study (N=30) to evaluate feasibility and acceptability, followed by a randomized controlled trial including approximately 240 participants randomized to either the lifestyle intervention or a wait-list control group. Outcomes will be measured at baseline, post-treatment, 2-month follow-up, and 6-month follow-up.
Вмешательства
- Поведенческое Digital Lifestyle Intervention
An 8-week culturally and linguistically adapted digital lifestyle intervention delivered via an online platform. The program includes psychoeducation and behavioral strategies targeting physical activity, sleep, diet, tobacco and alcohol use, and social engagement. Participants receive weekly guidance and feedback from a licensed psychologist or supervised psychology trainee.
Первичные конечные точки
- Kessler Psychological Distress Scale (K10) [Срок оценки: Baseline to post-treatment (8 weeks)]
Вторичные конечные точки (8)
- Kessler Psychological Distress Scale (K10) [Срок оценки: 2-month follow-up, and 6-month follow-up]
- Generalized Anxiety Disorder-7 (GAD-7) [Срок оценки: Baseline, post-treatment (8 weeks), 2-month follow-up, and 6-month follow-up]
- Perceived Stress Scale-4 (PSS-4) [Срок оценки: Baseline, post-treatment (8 weeks), 2-month follow-up, and 6-month follow-up]
- 12-Item Short-Form Health Survey (SF-12) [Срок оценки: Baseline, post-treatment (8 weeks), 2-month follow-up, and 6-month follow-up]
- Insomnia Severity Index (ISI) [Срок оценки: Baseline, post-treatment (8 weeks), 2-month follow-up, and 6-month follow-up]
- Godin Leisure-Time Exercise Questionnaire [Срок оценки: Baseline, post-treatment (8 weeks), 2-month follow-up, and 6-month follow-up]
- UCLA Loneliness Scale (3-item version) [Срок оценки: Baseline, post-treatment (8 weeks), 2-month follow-up, and 6-month follow-up]
- Barriers to Access to Care Evaluation (BACE-3). [Срок оценки: Baseline, post-treatment (8 weeks), and 2-month follow-up, and 6-month follow-up.]
Критерии участия
Критерии включения
- Migrant living in Sweden
- Age 18 years or older
- Moderate psychological distress (PHQ-9 ≥10, GAD-7 ≥10, or PSS-4 ≥8)
- Ability to read and write in easy Swedish or English
- Access to a computer or device with internet connection
- Motivation to engage in lifestyle change
- Ability to provide digital informed consent
Критерии исключения
- Severe psychiatric disorder
- Severe depression or suicide risk
- Severe medical illness
- Alcohol dependency
- Initiation or adjustment of psychotropic medication within the last 8 weeks
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
- Открытое
- Основная цель
- Профилактика
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07545239 · LIFT-RCT