Anxiety, Depression, Mental Health Disorder, Psychological Distress
Conditions
Keywords
Migrant mental health, Lifestyle intervention, Digital intervention, Prevention, Randomized controlled trial, CBT, Public health
Brief 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.
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
BEHAVIORALDigital 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
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Kessler Psychological Distress Scale (K10) | Baseline to post-treatment (8 weeks) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Kessler Psychological Distress Scale (K10) | 2-month follow-up, and 6-month follow-up | 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. |
| Generalized Anxiety Disorder-7 (GAD-7) | Baseline, post-treatment (8 weeks), 2-month follow-up, and 6-month follow-up | Severity of anxiety symptoms measured with the Generalized Anxiety Disorder-7 (GAD-7). |
| Perceived Stress Scale-4 (PSS-4) | Baseline, post-treatment (8 weeks), 2-month follow-up, and 6-month follow-up | Perceived stress measured with the Perceived Stress Scale-4 (PSS-4) |
| 12-Item Short-Form Health Survey (SF-12) | Baseline, post-treatment (8 weeks), 2-month follow-up, and 6-month follow-up | Health-related quality of life measured with the 12-Item Short-Form Health Survey (SF-12). |
| Insomnia Severity Index (ISI) | Baseline, post-treatment (8 weeks), 2-month follow-up, and 6-month follow-up | Sleep problems measured with the Insomnia Severity Index (ISI) |
| Godin Leisure-Time Exercise Questionnaire | Baseline, post-treatment (8 weeks), 2-month follow-up, and 6-month follow-up | Physical activity measured with the Godin Leisure-Time Exercise Questionnaire. |
| UCLA Loneliness Scale (3-item version) | Baseline, post-treatment (8 weeks), 2-month follow-up, and 6-month follow-up | Loneliness measured with the UCLA Loneliness Scale (3-item version) |
| Barriers to Access to Care Evaluation (BACE-3). | Baseline, post-treatment (8 weeks), and 2-month follow-up, and 6-month follow-up. | Perceived barriers to care measured with the Barriers to Access to Care Evaluation (BACE-3). |
Contacts
CONTACTJosefin Särnholm, PhD
PRINCIPAL_INVESTIGATORJosefin Särnholm
Karolinska Institutet
Outcome results
None listed