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临床试验/NCT07063121
NCT07063121已完成不适用

Evaluation of a Digital Application and a Guide for Promoting Subjective Well-Being and Resilience in Colombian Youths: A Randomized Clinical Trial

Fundación Centro Internacional de Educación y Desarrollo Humano1 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2023年2月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
184
试验地点
1
主要终点
Change in WHO-5 Well-Being Index Score

研究概览

简要总结

This study evaluated the effectiveness of a mobile application called Shadow's Edge, with or without a printed self-awareness guide, in improving well-being and emotional resilience among Colombian youth aged 18 to 22. A total of 184 participants were randomly assigned to three groups: one used the app only, another used both the app and the guide, and a control group received delayed access. Participants completed psychological assessments before and after the intervention. The main outcomes included changes in well-being and resilience measured with standardized scales. Results showed that the app improved well-being and resilience in the short term. However, adding the guide did not produce additional benefits. The study highlights the potential of digital mental health tools in promoting emotional well-being among young people in low- and middle-income countries.

详细描述

This study is a randomized clinical trial designed to evaluate the effectiveness of a mobile mental health application (Shadow's Edge) and a printed self-awareness guide (GSEA - Guide to Self-Awareness) in improving subjective well-being and emotional resilience among Colombian youth. The study was conducted in response to the growing demand for accessible, evidence-based mental health tools in low- and middle-income countries (LMICs), where structural barriers such as inequality, poverty, and conflict limit access to traditional mental health services. The COVID-19 pandemic further highlighted the need for remote, scalable solutions to address emotional well-being in youth populations.

Shadow's Edge is a narrative-based digital tool developed by the nonprofit Digging Deep Project. It combines principles from narrative therapy, positive psychology, and existential psychology. Through writing prompts and creative expression in a post-apocalyptic fictional setting, users are guided to explore their emotions and build resilience. The game environment fosters engagement by allowing users to rebuild a city devastated by a storm-a metaphor for personal adversity. It has been previously evaluated in different contexts, with promising results in mental health promotion and resilience-building among adolescents.

The Guide to Self-Awareness (GSEA), developed as a printed complement to the app, incorporates socio-emotional learning strategies to deepen reflection. It includes structured exercises that promote mindfulness, emotional regulation, goal-setting, empathy, and communication skills. Both tools were culturally adapted to the Colombian context between 2021 and 2022, involving feedback from local adolescents and youth leaders.

A total of 305 young people expressed interest in the study through an open call disseminated via youth organizations. From these, 210 met the eligibility criteria and were randomized into three groups using the randomizeR package in R. The eligibility criteria included being between 18 and 22 years old, residing in Colombia for at least 6 months, and not being regular users of high-action video games (based on guidance from the app developers, who indicated that such users may have lower engagement with narrative-based tools). Participants with prior experience using Shadow's Edge were excluded. The final sample included 184 participants.

The groups were structured as follows:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 22 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age between 18 and 22 years at the time of enrollment
  • •Resided in Colombia for at least 6 months prior to the start of the study
  • •Provided informed consent to participate
  • •Not a frequent user of high-action video games (e.g., first-person shooter or battle royale formats)
  • •Had not previously used the Shadow's Edge mobile application

排除标准

  • •Any participant sharing a household or close familial relationship with another enrolled participant (to prevent contamination across study arms)
  • •Failure to meet any of the inclusion criteria

研究组 & 干预措施

App only

Experimental

Participants in this arm used only the Shadow's Edge mobile application. They were instructed to engage with the app for at least 20 minutes per day over an 8-week period. The app promotes emotional expression, self-reflection, and resilience through a narrative-based experience that includes writing prompts and creative activities.

干预措施: Shadow's Edge mobile app (Behavioral)

App + Guide

Experimental

Participants in this arm used both the Shadow's Edge mobile application and the printed Guide to Self-Awareness (GSEA). The intervention was delivered over 8 weeks, with daily use of the app and weekly completion of guided reflection activities. The guide was designed to enhance emotional insight, mindfulness, and social-emotional skills.

干预措施: Shadow's Edge mobile app (Behavioral)

App + Guide

Experimental

Participants in this arm used both the Shadow's Edge mobile application and the printed Guide to Self-Awareness (GSEA). The intervention was delivered over 8 weeks, with daily use of the app and weekly completion of guided reflection activities. The guide was designed to enhance emotional insight, mindfulness, and social-emotional skills.

干预措施: Guide to Self-Awareness (GSEA) (Behavioral)

Waitlist Control

No Intervention

Participants in this arm did not receive the intervention during the first two assessments. They were evaluated at two timepoints without access to the app or guide. After the second assessment, they received access to both the Shadow's Edge app and the GSEA for ethical and comparative purposes.

结局指标

主要结局

Change in WHO-5 Well-Being Index Score

时间窗: Baseline (Week 0), Week 4, and Week 8

The WHO-5 Well-Being Index is a 5-item self-report scale developed by the World Health Organization to assess subjective psychological well-being over the past two weeks. Each item is rated on a 6-point Likert scale ranging from 0 ("At no time") to 5 ("All of the time"). Total scores range from 0 to 25, with higher scores indicating better well-being. The instrument has been validated in Colombia (Campo-Arias et al., 2015) and is widely used in clinical trials. Changes in scores across the three measurement points (baseline, 4 weeks, and 8 weeks) will be used to assess the effectiveness of the intervention.

次要结局

  • Change in Abbreviated Resilience Scale (EAR) Score(Baseline (Week 0), Week 4, and Week 8)
  • Change in Abbreviated Resilient Coping Scale (EAAR) Score(Baseline (Week 0), Week 4, and Week 8)

研究者

发起方
Fundación Centro Internacional de Educación y Desarrollo Humano
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sara Victoria Alvarado Salgado

General Director of CINDE

Fundación Centro Internacional de Educación y Desarrollo Humano

研究点 (1)

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