Digital Lifestyle Intervention for Mental Health Among Migrants: Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Digital Lifestyle Intervention.
- Who it may be relevant to
- Registry conditions: Mental Health Disorder, Depression, Anxiety, Psychological Distress. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Digital Lifestyle Intervention to Improve Mental Health Among Migrants: A Randomized Controlled Trial With a Nested Pilot Study
Overview
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.
Detailed description
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.
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.
Primary outcome measures
- Kessler Psychological Distress Scale (K10) [Time frame: Baseline to post-treatment (8 weeks)]
Secondary outcome measures (8)
- Kessler Psychological Distress Scale (K10) [Time frame: 2-month follow-up, and 6-month follow-up]
- Generalized Anxiety Disorder-7 (GAD-7) [Time frame: Baseline, post-treatment (8 weeks), 2-month follow-up, and 6-month follow-up]
- Perceived Stress Scale-4 (PSS-4) [Time frame: Baseline, post-treatment (8 weeks), 2-month follow-up, and 6-month follow-up]
- 12-Item Short-Form Health Survey (SF-12) [Time frame: Baseline, post-treatment (8 weeks), 2-month follow-up, and 6-month follow-up]
- Insomnia Severity Index (ISI) [Time frame: Baseline, post-treatment (8 weeks), 2-month follow-up, and 6-month follow-up]
- Godin Leisure-Time Exercise Questionnaire [Time frame: Baseline, post-treatment (8 weeks), 2-month follow-up, and 6-month follow-up]
- UCLA Loneliness Scale (3-item version) [Time frame: Baseline, post-treatment (8 weeks), 2-month follow-up, and 6-month follow-up]
- Barriers to Access to Care Evaluation (BACE-3). [Time frame: Baseline, post-treatment (8 weeks), and 2-month follow-up, and 6-month follow-up.]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07545239 · LIFT-RCT