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Предстои набиране Не е приложимо NCT07545239

Digital Lifestyle Intervention for Mental Health Among Migrants: Randomized Controlled Trial

Не е приложима фаза (напр. обсервационно)
Заболявания: Mental Health Disorder Depression Anxiety Psychological Distress

Спонсор: Karolinska Institutet

Налично на: БГ
Обобщение
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.
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.
Кой може да участва
Inclusion Criteria: * 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 Exclusion Criteria: * Severe psychiatric disorder * Severe depression or suicide risk * Severe medical illness * Alcohol dependency * Initiation or adjustment of psychotropic medication within the last 8 weeks
Интервенции
Digital Lifestyle Intervention
BEHAVIORAL
Места на провеждане

Информация за локации не е налична.

Технически детайли
Статус
Предстои набиране
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
01.04.2026
Крайна дата
01.10.2028
Регистрационен номер
NCT07545239
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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