Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07545239

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Mental Health Disorder Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Psychological Distress

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: LIFT Lifestyle Intervention

Primary outcomes

  1. Kessler Psychological Distress Scale (K10)

    Time frame: 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 outcomes

  1. Kessler Psychological Distress Scale (K10)

    Time frame: 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.

  2. Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: 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).

  3. Perceived Stress Scale-4 (PSS-4)

    Time frame: 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)

  4. 12-Item Short-Form Health Survey (SF-12)

    Time frame: 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).

  5. Insomnia Severity Index (ISI)

    Time frame: Baseline, post-treatment (8 weeks), 2-month follow-up, and 6-month follow-up

    Sleep problems measured with the Insomnia Severity Index (ISI)

  6. Godin Leisure-Time Exercise Questionnaire

    Time frame: Baseline, post-treatment (8 weeks), 2-month follow-up, and 6-month follow-up

    Physical activity measured with the Godin Leisure-Time Exercise Questionnaire.

  7. UCLA Loneliness Scale (3-item version)

    Time frame: Baseline, post-treatment (8 weeks), 2-month follow-up, and 6-month follow-up

    Loneliness measured with the UCLA Loneliness Scale (3-item version)

  8. 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.

    Perceived barriers to care measured with the Barriers to Access to Care Evaluation (BACE-3).

Study contacts

Contact information is provided by the study sponsor or research team.

Josefin Särnholm, PhD

CONTACT

[email protected]

+46(0) 8 123 400 00

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Digital Lifestyle Intervention to Improve Mental Health Among Migrants: A Randomized Controlled Trial With a Nested Pilot Study

Acronym: LIFT-RCT

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.