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

NCT07545239 | Not Yet Recruiting

• 1 other identifier: LIFT-RCT
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mental Health Disorder; Depression; Anxiety; Psychological Distress

Keywords

Migrant mental health; Lifestyle intervention; Digital intervention; Prevention; Randomized controlled trial; CBT; Public health

Outcome Measures

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.

  Baseline to post-treatment (8 weeks)

Secondary Outcomes (8)

• Kessler Psychological Distress Scale (K10)

  2-month follow-up, and 6-month follow-up

• 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)

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

• 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)

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

Study Arms (2)

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.

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.

Interventions

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.

Also known as: LIFT Lifestyle Intervention

Digital Lifestyle Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Severe psychiatric disorder
• Severe depression or suicide risk
• Severe medical illness
• Alcohol dependency
• Initiation or adjustment of psychotropic medication within the last 8 weeks

Sponsors & Collaborators

• Karolinska Institutet: lead

MeSH Terms

Conditions

Mental Disorders; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Josefin Särnholm

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Josefin Särnholm, PhD

CONTACT

+46(0) 8 123 400 00; josefin.sarnholm@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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.

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 22, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share