The Effects of Mindhelper.dk: a Self-guided Digital Mental Health Promotion Service Targeting Young People
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,355
- 试验地点
- 1
- 主要终点
- General well-being measure by "The Well-Being Index WHO-5" (WHO5)
研究概览
简要总结
In a two-armed randomized controlled trial 15-25-year-olds will be recruited via social media to evaluate the effectiveness of Mindhelper.dk; a Danish self-guided, digital, mental health service offering information, self-help tools, and guidance to young people. Participants will be randomly allocated to an intervention group (receiving information about Mindhelper.dk) or a control group (no information about Mindhelper.dk). Outcomes, including well-being (WHO5), psychological functioning (SWEMWBS), help-seeking intentions, and body appreciation (2-item BAS-2SF), will be measured at 2-, 6-, and 12-weeks post-randomization and analyzed using the intention-to-treat approach. Qualitative interviews with intervention group participants will provide complementary insights, and a cost-effectiveness analysis will also be conducted.
详细描述
A study protocol will be made publicly accessible upon acceptance for publication in a suitable journal
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
盲法说明
The participants are partly masked. The control group will be masked; however, the intervention group will not be masked.
There is no care provider nor outcome assessor as all measures are self-reported and collected through online questionnaires.
Analyses of data and interpretation of results will be done masked.
入排标准
- 年龄范围
- 15 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 15-25
排除标准
- 未提供
研究组 & 干预措施
Intervention group
The intervention group will receive information about Mindhelper.dk and inspiration on how to use Mindhelper through text-messages during the study period.
干预措施: Mindhelper- A national youth mental health promotion website (Behavioral)
Control group
The control group does not receive information about Mindhelper.dk, until after completion of the last follow-up questionnaire.
结局指标
主要结局
General well-being measure by "The Well-Being Index WHO-5" (WHO5)
时间窗: Baseline and randomization(T1), 2 weeks (T2), 6 weeks(T3) and 12 weeks (T4) after randomization.
The WHO5 scores range between 0 and 100. The higher score, the higher level of well-being. The effects of Mindhelper on well-being are measured through surveys disseminated to the study participants. The primary assessment of effect is conducted at T2.
次要结局
- Psychological functioning, measure by "The Short Warwick-Edinburgh Mental Well-Being Scale" (SWEMWBS).(Baseline and randomization(T1), 2 weeks (T2), 6 weeks(T3) and 12 weeks (T4) after randomization.)
研究者
Anna Paldam Folker
Head of Research, Professor, ph.d.
University of Southern Denmark