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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital Lifestyle Intervention | Experimental | Participants receive an 8-week culturally and linguistically adapted digital lifestyle intervention targeting physical activity, sleep, diet, and social engagement. The intervention includes psychoeducation, behavioral strategies, and guidance from a psychologist via an online platform. |
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| Wait-list Control | No Intervention | Participants assigned to the wait-list control group receive access to a general lifestyle information module and are offered the digital lifestyle intervention after the 2-month follow-up assessment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Lifestyle Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Kessler Psychological Distress Scale (K10) | The Kessler Psychological Distress Scale (K10) is a 10-item self-report measure assessing psychological distress (anxiety and depressive symptoms) during the past 4 weeks. Each item is rated on a 5-point scale, and total scores range from 10 to 50, with higher scores indicating greater psychological distress. | Baseline to post-treatment (8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Kessler Psychological Distress Scale (K10) | The Kessler Psychological Distress Scale (K10) is a 10-item self-report measure assessing psychological distress (anxiety and depressive symptoms) during the past 4 weeks. Each item is rated on a 5-point scale, and total scores range from 10 to 50, with higher scores indicating greater psychological distress. | 2-month follow-up, and 6-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Josefin Särnholm, PhD | Contact | +46(0) 8 123 400 00 | josefin.sarnholm@ki.se |
| Name | Affiliation | Role |
|---|---|---|
| Josefin Särnholm | Karolinska Institutet | Principal Investigator |
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Individual participant data will not be publicly shared due to privacy regulations and ethical restrictions under Swedish law.
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| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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Participants will be randomized to either an 8-week culturally and linguistically adapted digital lifestyle intervention or a wait-list control group receiving a general lifestyle module. Following the 2-month follow-up, participants in the control group will be offered the intervention. The study includes a nested pilot phase to assess feasibility and acceptability prior to the main randomized controlled trial.
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| Generalized Anxiety Disorder-7 (GAD-7) | Severity of anxiety symptoms measured with the Generalized Anxiety Disorder-7 (GAD-7). | Baseline, post-treatment (8 weeks), 2-month follow-up, and 6-month follow-up |
| Perceived Stress Scale-4 (PSS-4) | Perceived stress measured with the Perceived Stress Scale-4 (PSS-4) | Baseline, post-treatment (8 weeks), 2-month follow-up, and 6-month follow-up |
| 12-Item Short-Form Health Survey (SF-12) | Health-related quality of life measured with the 12-Item Short-Form Health Survey (SF-12). | Baseline, post-treatment (8 weeks), 2-month follow-up, and 6-month follow-up |
| Insomnia Severity Index (ISI) | Sleep problems measured with the Insomnia Severity Index (ISI) | Baseline, post-treatment (8 weeks), 2-month follow-up, and 6-month follow-up |
| Godin Leisure-Time Exercise Questionnaire | Physical activity measured with the Godin Leisure-Time Exercise Questionnaire. | Baseline, post-treatment (8 weeks), 2-month follow-up, and 6-month follow-up |
| UCLA Loneliness Scale (3-item version) | Loneliness measured with the UCLA Loneliness Scale (3-item version) | Baseline, post-treatment (8 weeks), 2-month follow-up, and 6-month follow-up |
| Barriers to Access to Care Evaluation (BACE-3). | Perceived barriers to care measured with the Barriers to Access to Care Evaluation (BACE-3). | Baseline, post-treatment (8 weeks), and 2-month follow-up, and 6-month follow-up. |