Digital Lifestyle Intervention for Mental Health Among Migrants: Randomized Controlled Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarolinska Institutet
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Severe psychiatric disorder
Severe depression or suicide risk
Severe medical illness
Alcohol dependency
Trial design
Design model
Parallel
Treatments tested in this trial
Digital Lifestyle Intervention
BehavioralAn 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.
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: Digital Lifestyle InterventionExperimental treatment 1 intervention
Group B: Wait-list ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline to post-treatment (8 weeks)Secondary outcomes
1
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.
Time frame
2-month follow-up, and 6-month follow-up2
Generalized Anxiety Disorder-7 (GAD-7)
Severity of anxiety symptoms measured with the Generalized Anxiety Disorder-7 (GAD-7).
Time frame
Baseline, post-treatment (8 weeks), 2-month follow-up, and 6-month follow-up3
Perceived Stress Scale-4 (PSS-4)
Perceived stress measured with the Perceived Stress Scale-4 (PSS-4)
Time frame
Baseline, post-treatment (8 weeks), 2-month follow-up, and 6-month follow-up4
12-Item Short-Form Health Survey (SF-12)
Health-related quality of life measured with the 12-Item Short-Form Health Survey (SF-12).
Time frame
Baseline, post-treatment (8 weeks), 2-month follow-up, and 6-month follow-upLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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