App-Based Intervention for Youth Well-Being and Resilience in Colombia

NCT07063121 | Completed

• 1 other identifier: SE-GSEA
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mental Health Promotion; Subjective Well-Being; Emotional Resilience

Keywords

Digital mental health; Mobile health intervention; Subjective well-being; Emotional resilience; Youth mental health; Behavioral intervention; App-based intervention

Outcome Measures

Primary Outcomes (1)

• Change in WHO-5 Well-Being Index Score

  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.

  Baseline (Week 0), Week 4, and Week 8

Secondary Outcomes (2)

• 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

Study Arms (3)

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.

Behavioral: Shadow's Edge mobile app

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.

Behavioral: Shadow's Edge mobile app; Behavioral: Guide to Self-Awareness (GSEA)

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.

Interventions

Shadow's Edge mobile app BEHAVIORAL

A mobile application adapted for Colombian youth that uses interactive storytelling, journaling, and emotional regulation activities to promote subjective well-being and resilience.

App + Guide; App only

Guide to Self-Awareness (GSEA) BEHAVIORAL

A printed guide developed to promote emotional insight, mindfulness, self-awareness, and social-emotional skills through structured reflection activities. Designed to be used alongside the Shadow's Edge app.

App + Guide

Eligibility Criteria

• Age: 18 Years - 22 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Any participant sharing a household or close familial relationship with another enrolled participant (to prevent contamination across study arms)

Sponsors & Collaborators

• Fundación Centro Internacional de Educación y Desarrollo Humano: lead
• The Digging Deep Project: collaborator
• Fondation Botnar (Switzerland): collaborator

Study Sites (1)

Sede Bogotá

Bogotá, 110221, Colombia

Location

Study Officials

• Orlando Scoppetta, Ph.D.

  Fundación Centro Internacional de Educación y Desarrollo Humano

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Director of CINDE

Model Details: This study used a three-arm parallel assignment design to evaluate the effects of a digital mental health intervention. Participants were randomized into one of three groups: (1) Shadow's Edge app only, (2) Shadow's Edge app plus a printed Guide to Self-Awareness (GSEA), and (3) a waitlist control group. The interventions were delivered concurrently across groups over an 8-week period. The control group did not receive the intervention during the initial data collection phase but was given access to both the app and the guide after their second assessment. No crossover occurred during the intervention period. All participants completed repeated measures at regular intervals. This model allowed for the evaluation of short-term changes in subjective well-being and resilience, and the comparison of intervention effects between groups. Random assignment was conducted using computerized allocation and stratified to ensure balance in sex and age distribution.

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 14, 2025
• Study Start: February 2, 2023
• Primary Completion: May 5, 2023
• Study Completion: May 12, 2023
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available beginning 6 months after publication of the main findings and for up to 5 years thereafter.
• Access Criteria: Data will be made available to qualified researchers upon reasonable request for purposes consistent with the original study objectives. A data use agreement will be required.

Locations

CO (1)