Mental Health DisorderLIFT-RCTNCT07545239
Digital Lifestyle Intervention for Mental Health Among Migrants: Randomized Controlled Trial
A study testing Digital Lifestyle Intervention in people with Mental Health Disorder and Depression, run by Karolinska Institutet.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health Disorder, Depression, Anxiety
- What is being tested?
- Digital Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Severe psychiatric disorder
- Severe depression or suicide risk
- Severe medical illness
- Alcohol dependency
- Initiation or adjustment of psychotropic medication within the last 8 weeks
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Mental Health Disorder, Depression, Anxiety, Psychological Distress
- Being tested
- Digital Lifestyle Intervention
- Keywords
- Migrant mental health, Lifestyle intervention, Digital intervention, Prevention, Randomized controlled trial, CBT, Public health
- Medical subject headings
- Mental Disorders, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Lifestyle InterventionBehavioural
Also called LIFT 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Digital Lifestyle Intervention |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to post-treatment (8 weeks)
Secondary outcomes (8)
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.
Measured: 2-month follow-up, and 6-month follow-up
Generalized Anxiety Disorder-7 (GAD-7)
Severity of anxiety symptoms measured with the Generalized Anxiety Disorder-7 (GAD-7).
Measured: 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)
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 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).
Measured: Baseline, post-treatment (8 weeks), and 2-month follow-up, and 6-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health DisorderStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josefin Särnholm, Karolinska Institutet
- Investigators
- Josefin Särnholm, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545239
- Sponsor's protocol ID
- LIFT-RCT
- Acronym
- LIFT-RCT
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared due to privacy regulations and ethical restrictions under Swedish law.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Lifestyle Intervention to Improve Mental Health Among Migrants: A Randomized Controlled Trial With a Nested Pilot Study
- ClinicalTrials.gov ID
- NCT07545239
- Acronym / sponsor ID
- LIFT-RCT / LIFT-RCT
- Conditions
- Mental Health Disorder, Depression, Anxiety, Psychological Distress
- Keywords
- Migrant mental health, Lifestyle intervention, Digital intervention, Prevention, Randomized controlled trial, CBT, Public health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Digital Lifestyle Intervention | Experimental | Behavioral: Digital Lifestyle InterventionParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- Severe psychiatric disorder
- Severe depression or suicide risk
- Severe medical illness
- Alcohol dependency
- Initiation or adjustment of psychotropic medication within the last 8 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Lifestyle InterventionAlso: LIFT Lifestyle InterventionAn 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. | Behavioural | Digital Lifestyle Intervention |
Primary outcome
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.
8 secondary outcomes
Kessler Psychological Distress Scale (K10)
Time frame: 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
Perceived Stress Scale-4 (PSS-4)
Time frame: 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
Insomnia Severity Index (ISI)
Time frame: 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
UCLA Loneliness Scale (3-item version)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared due to privacy regulations and ethical restrictions under Swedish law.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Josefin Särnholm principal investigator
Karolinska Institutet
Questions about this trial
What is this clinical trial studying?
A study testing Digital Lifestyle Intervention in people with Mental Health Disorder and Depression, run by Karolinska Institutet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Josefin Särnholm, PhD (+46(0) 8 123 400 00, josefin.sarnholm@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kessler Psychological Distress Scale (K10) (time frame: Baseline to post-treatment (8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.