Digital Lifestyle Intervention for Mental Health Among Migrants: Randomized Controlled Trial (LIFT-RCT)

April 16, 2026 updated by: Josefin Särnholm, Karolinska Institutet

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Digital Lifestyle Intervention
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.
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.
Other Names:
  • LIFT Lifestyle Intervention
No Intervention: Wait-list Control
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline to post-treatment (8 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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-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
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)
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)
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
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)
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)
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
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)
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)
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Josefin Särnholm, Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LIFT-RCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be publicly shared due to privacy regulations and ethical restrictions under Swedish law.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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