Smartphone Screen Time Reduction Improves Mental Health: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 2
- 主要终点
- Depressive Symptoms
研究概览
简要总结
The aim of the present RCT is to investigate the effect of smartphone screen time reduction on mental health indicators in healthy, 18-29 yo Austrian students.
After inclusion and randomization to intervention- and control group, normal screen time behavior will be assessed for 10-days. After that, the mental health parameters will be carried out in both groups as a baseline survey (T0). After that, intervention group should limit smartphone screen time to less than 2 hours per day for three consecutive weeks. Control group should use smartphones as usual. After that, mental health parameters will be assessed again in both groups (post-intervention, T1). After T1, there are no further requirements regarding screen time. Mental health parameters will be assessed again in both groups at follow-up (T2).
Main outcome parameters are 1) Well-Being (WHO-5), depressive symptoms (PHQ-9), stress (PSQ-20), and sleep quality (ISI).
The primary hypothesis (stated at Open Science Framework before Enrollment: https://osf.io/a9k76) is that mental health indicators, particularly stress, depressive symptoms, and sleep quality will improve throughout the intervention compared to the control group as well as to baseline.
详细描述
According to the power-analysis (small to medium effect size of d=.45, power .8, significance level < .05, icc = .05), a sample of N > 100 should be recruited through newsletter, notices and social media. The inclusion criteria are more than 3 hours of screen time per day, no mental disorder, no ongoing psychotherapy or use of psychotropic drugs.
After signing the informed consent, participants have to download an App (ESMira®), which processes the whole study. The first step is to fill out sociodemographic data, smartphone use and mental health questionnaires. After controlling for inclusion- and exclusion criteria, ESMira will randomize into intervention- (IG) and control group (CG). Participants in the control group (CG) should continue their smartphone behavior unchanged throughout the entire study period. Participants in the intervention group (IG) should continue their smartphone usage unchanged for the first 10 days (Baseline.) After that, the mental health parameters will be carried out in both groups as a baseline survey (T0). After that, participants of the intervention group should limit their smartphone screen time under two hours per day for three weeks. To comply with that, participants should use the limiter function of their smartphone or download an additional app. A screen shot of the screen time has to be uploaded weekly on Monday for the previous week (Monday to Sunday). At the end of the intervention (t1), the mental health questionnaires will be collected again in both groups. After T1, there are no further requirements regarding screen time. Mental health parameters will be assessed again in both groups at follow-up (T2).
During the study period participants will be asked to additionally wear a fitness tracker to measure daily movement as well as objective stress parameters.
Data collection and randomization The whole data collection procedure will be carried out through the ESMira App. ESMira is a tool for running longitudinal studies (ESM, AA, EMA, ...) with completely anonymized communication with participants and data collection.
Smartphone screen time Weekly screen time will be documented in both groups using the smartphones' built-in screen time measurements.
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 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-29 years old
- •male/female
- •daily screen time > 3 h/d
- •no mental disorder
- •no ongoing psychotherapy
- •no psychotropic drugs
排除标准
- •< 18 yo or > 29 yo
- •daily screen time < 3 h/d
- •mental disorder (self-statement)
- •in ongoing psychotherapy
- •psychotropic drug use
结局指标
主要结局
Depressive Symptoms
时间窗: The questionnaire will be assessed at 3 time points, 1) at baseline (=immediately pre-intervention (t0), 2) immediatly after the 3-week intervention (t1), and 3) at Follow-Up (t2= six weeks post intervention).
Patient Health Questionnaire (PHQ-9): The PHQ-9 contains nine self-rating items on a four-point scale ranging from 0 ("not at all") to 3 ("nearly every day"), resulting in a total score from 0 to 27. Higher scores indicate more depressive symptoms.
Sleep Quality
时间窗: The questionnaire will be assessed at 3 time points, 1) at baseline (=immediately pre-intervention (t0), 2) immediatly after the 3-week intervention (t1), and 3) at Follow-Up (t2= six weeks post intervention).
Insomnia Severity Index (ISI): The ISI comprises 7 self-reported items, each rated on a scale from 0 to 4, resulting in sum scores from 0 to 28. Higher scores indicate more insomnia symptoms or less sleep quality.
Stress
时间窗: The questionnaire will be assessed at 3 time points, 1) at baseline (=immediately pre-intervention (t0), 2) immediatly after the 3-week intervention (t1), and 3) at Follow-Up (t2= six weeks post intervention).
Perceived Stress Questionnaire (PSQ-20): Each item is rated from almost never (=1) to usually (= 4), with a sum score from 20 to 80. Higher scores indicate more stress.
Well-being
时间窗: The questionnaire will be assessed at 3 time points, 1) at baseline (=immediately pre-intervention (t0), 2) immediatly after the 3-week intervention (t1), and 3) at Follow-Up (t2= six weeks post intervention).
World Health Organization well-being questionnaire (WHO-5): The WHO-5 contains 5 items (0 to 5 points). Scores range from 0 (no well-being) to 25 points (maximal well-being).
次要结局
- Problematic smartphone use(The questionnaire will be assessed at 3 time points, 1) at baseline (=immediately pre-intervention (t0), 2) immediatly after the 3-week intervention (t1), and 3) at Follow-Up (t2= six weeks post intervention).)
- Body Appreciation(The questionnaire will be assessed at 3 time points, 1) at baseline (=immediately pre-intervention (t0), 2) immediatly after the 3-week intervention (t1), and 3) at Follow-Up (t2= six weeks post intervention).)
- Anxiety Symptoms(The questionnaire will be assessed at 3 time points, 1) at baseline (=immediately pre-intervention (t0), 2) immediatly after the 3-week intervention (t1), and 3) at Follow-Up (t2= six weeks post intervention).)
- Eating Disorder(The questionnaire will be assessed at 3 time points, 1) at baseline (=immediately pre-intervention (t0), 2) immediatly after the 3-week intervention (t1), and 3) at Follow-Up (t2= six weeks post intervention).)
研究者
Christoph Pieh
Full Professor and Head of Department
Danube University Krems