Not_yet_recruitingNANCT07545239

Digital Lifestyle Intervention to Improve Mental Health Among Migrants: A Randomized Controlled Trial With a Nested Pilot Study

Sponsor: Karolinska Institutet

Trial Details

Condition	Mental Health Disorder, Depression, Anxiety, Psychological Distress
Intervention	Digital Lifestyle Intervention
Phase	NA
Status	Not_yet_recruiting
Participants	240
Est. Completion	1 Apr 2028
Last Updated	22 Apr 2026

Primary Outcome

Kessler Psychological Distress Scale (K10)

Eligibility Criteria

Inclusion Criteria

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

View Registry Entry

Related Analysis

Phase III Digital Mental Health Trial for Migrants Opens in Sweden — Culturally Adapted Lifestyle Intervention Shows Promise

A groundbreaking randomised controlled trial in Sweden will test a culturally adapted digital lifestyle intervention for migrants experiencing psychological distress. The 8-week program targets physical activity, sleep, diet, and social engagement to improve mental health outcomes in this vulnerable population.

Read full article →

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