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

NCT07545239 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-04-22

No results posted yet for this study

Summary

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.

Conditions

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

Principal Investigators

  • Josefin Särnholm · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2028-04-30
Completion
2028-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07545239 on ClinicalTrials.gov