The Effectiveness of Engagement-based Personalization of a Two-week Digital Mental Health Intervention Targeting Wellbeing: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change from baseline in wellbeing, measured with the Mental Health Continuum Short Form, at 3 weeks.
研究概览
简要总结
This study will investigate the effectiveness of an engagement-based personalized 2-week mobile wellbeing intervention, vs the effectiveness of a non-personalized 2-week mobile wellbeing intervention.
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
盲法说明
Participants will not be informed about their randomized condition (personalized or non-personalized), but it is likely that they will infer it from the intervention that they receive.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •at least mild depressive or anxiety complaints; >4 Generalized Anxiety Disorder 7-item scale OR Patient Health Questionnaire 9-item scale
- •access to smartphone with internet
- •adequate English literacy
排除标准
- 未提供
研究组 & 干预措施
Personalized
Participants in the personalized arm will receive the optimal combination of content, feedback and design, based on their baseline engagement scores.
干预措施: personalized 2-week mobile wellbeing intervention (Behavioral)
non-personalized
Participants in the non-personalized arm will receive a randomly selected version of the 27 possible interventions, regardless of their baseline engagement scores.
干预措施: non-personalized 2-week mobile wellbeing intervention (Behavioral)
结局指标
主要结局
Change from baseline in wellbeing, measured with the Mental Health Continuum Short Form, at 3 weeks.
时间窗: baseline, 3 weeks
Wellbeing will be measured in an online survey, using the Mental Health Continuum Short Form. This validated scale consists of 14 items. The scale's total scores range from 14 to 84, with higher scores indicating higher wellbeing and thus better outcomes.
Change from baseline in depressive symptoms, measured with the Patient Health Questionnaire-9, at 3 weeks.
时间窗: baseline, 3 weeks
Depressive symptoms will be measured in an online survey, using the Patient Health Questionnaire-9. This validated scale consists of 9 items. The scale's total scores range from 0 to 27, with higher scores indicating higher depressive symptoms and thus worse outcomes.
Change from baseline in anxiety symptoms, measured with the Generalized Anxiety Disorder 7-item scale, at 3 weeks.
时间窗: baseline, 3 weeks
Depressive symptoms will be measured in an online survey, using the Generalized Anxiety Disorder 7-item scale. This validated scale consists of 6 items. The scale's total scores range from 0 to 21, with higher scores indicating higher anxiety symptoms and thus worse outcomes.
次要结局
- Adherence(after 3 weeks)
- Change from baseline in wellbeing, measured with the Mental Health Continuum Short Form, at 8 weeks.(baseline, 8 weeks)
- Change from baseline in depressive symptoms, measured with the Patient Health Questionnaire-9, at 8 weeks.(baseline, 8 weeks)
- Change from baseline in anxiety symptoms, measured with the Generalized Anxiety Disorder 7-item scale, at 8 weeks.(baseline, 8 weeks)
- Engagement, measured with the TWente Engagement with Ehealth Technologies Scale.(after 3 weeks)
- Engagement, measured with the TWente Engagement with Ehealth Technologies Scale.(after 1 day)
- Engagement, measured with the TWente Engagement with Ehealth Technologies Scale.(after 7 days)
研究者
Saskia Kelders
Associate Professor
University of Twente