Digital Lifestyle Intervention to Improve Mental Health Among Migrants: A Randomized Controlled Trial With a Nested Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 240
- 主要终点
- Kessler Psychological Distress Scale (K10)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Severe psychiatric disorder
- •Severe depression or suicide risk
- •Severe medical illness
- •Alcohol dependency
- •Initiation or adjustment of psychotropic medication within the last 8 weeks
研究组 & 干预措施
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.
干预措施: Digital Lifestyle Intervention (Behavioral)
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.
结局指标
主要结局
Kessler Psychological Distress Scale (K10)
时间窗: 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.
次要结局
- 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)
- 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)(Baseline, post-treatment (8 weeks), 2-month follow-up, and 6-month follow-up)
- Barriers to Access to Care Evaluation (BACE-3).(Baseline, post-treatment (8 weeks), and 2-month follow-up, and 6-month follow-up.)
研究者
Josefin Särnholm
PhD
Karolinska Institutet