Mental Health PromotionShEdge-COLNCT07063121
App-Based Intervention for Youth Well-Being and Resilience in Colombia
A study testing Shadow's Edge mobile app and Guide to Self-Awareness (GSEA) in people with Mental Health Promotion and Subjective Well-Being, run by Fundación Centro Internacional de Educación y Desarrollo Humano at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Promotion, Subjective Well-Being, Emotional Resilience
- What is being tested?
- Shadow's Edge mobile app and Guide to Self-Awareness (GSEA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteColombia
- Study dates
- 2 Feb 2023to 12 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 22 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Digital Application and a Guide for Promoting Subjective Well-Being and Resilience in Colombian Youths: A Randomized Clinical Trial
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.
Read the detailed description
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:
App Group: Participants used Shadow's Edge only.
App + Guide Group: Participants used Shadow's Edge and completed exercises from the GSEA.
Control Group (Waitlist): Participants received delayed access to both tools after a second baseline measurement.
Data were collected using three validated instruments:
- WHO-5 Well-Being Index (Campo-Arias et al., 2015 - Colombian validation): Measures subjective well-being over the last two weeks using five items on a Likert scale.
- Abbreviated Resilience Scale (EAR) (Rodríguez-Rey et al., 2016 - Spanish validation): A six-item scale assessing perceived resilience.
- Abbreviated Resilient Coping Scale (EAAR) (Trejos-Herrera et al., 2023 - Colombian validation): A four-item scale measuring resilient coping behaviors.
Measurements were taken in person at baseline and at 4 and 8 weeks for the intervention groups. The control group was evaluated four times: twice prior to gaining access to the tools and twice after. All instruments were administered in print. Compliance with the app usage was monitored via daily digital progress logs and backend usage data linked to anonymous codes. Participants were encouraged to use the app for at least 20 minutes daily.
Statistical analysis was conducted using mixed-effects regression models in R, controlling for group assignment, age, sex, and the number of words written in the app journal (used as a proxy for engagement). The analysis aimed to determine changes over time in each outcome measure, as well as between-group differences.
- Being tested
- Shadow's Edge mobile app, Guide to Self-Awareness (GSEA)
- Keywords
- Digital mental health, Mobile health intervention, Subjective well-being, Emotional resilience, Youth mental health, Behavioral intervention, App-based intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shadow's Edge mobile appBehavioural
A mobile application adapted for Colombian youth that uses interactive storytelling, journaling, and emotional regulation activities to promote subjective well-being and resilience.
Guide to Self-Awareness (GSEA)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Week 0), Week 4, and Week 8
Secondary outcomes (2)
Change in Abbreviated Resilience Scale (EAR) Score
The Abbreviated Resilience Scale (EAR) is a 6-item self-report measure used to assess perceived resilience, including the ability to recover from stress. Each item is rated on a 5-point Likert scale. Total scores range from 6 to 30, with higher scores indicating greater resilience. The Spanish version validated in Colombia (Rodríguez-Rey et al., 2016) was used in this study. Scores were collected at baseline, week 4, and week 8 to assess changes in resilience across time and study groups.
Measured: Baseline (Week 0), Week 4, and Week 8
Change in Abbreviated Resilient Coping Scale (EAAR) Score
The Abbreviated Resilient Coping Scale (EAAR) is a 4-item self-report measure designed to assess resilient coping behavior under stress. Each item is rated on a 5-point Likert scale, yielding total scores ranging from 4 to 20. Higher scores indicate stronger coping ability. The Colombian validation by Trejos-Herrera et al. (2023) was used in this study. Scores were obtained at three time points to analyze improvements in coping strategies over time.
Measured: Baseline (Week 0), Week 4, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start2 Feb 2023
- Primary completion5 May 2023
- Study completion12 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health PromotionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Centro Internacional de Educación y Desarrollo Humano
- Sponsor type
- University, hospital or other
- Collaborators
- The Digging Deep Project, Fondation Botnar (Switzerland)
- Responsible party
- Principal investigator, Sara Victoria Alvarado Salgado, Fundación Centro Internacional de Educación y Desarrollo Humano
- Investigators
- Orlando Scoppetta, Ph.D., Study director, Fundación Centro Internacional de Educación y Desarrollo Humano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07063121
- Sponsor's protocol ID
- SE-GSEA
- Acronym
- ShEdge-COL
- Status last verified
- Jul 2025
- First submitted
- 24 Jun 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) related to primary and secondary outcomes (WHO-5, EAR, and EAAR scores), collected at all time points.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Digital Application and a Guide for Promoting Subjective Well-Being and Resilience in Colombian Youths: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07063121
- Acronym / sponsor ID
- ShEdge-COL / SE-GSEA
- Keywords
- Digital mental health, Mobile health intervention, Subjective well-being, Emotional resilience, Youth mental health, Behavioral intervention, App-based intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Fundación Centro Internacional de Educación y Desarrollo HumanoUniversity, hospital or other
- Collaborators
- The Digging Deep Project, Fondation Botnar (Switzerland)
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 5 May 2023 (actual)
- Study completion
- 12 May 2023 (actual)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
App Group: Participants used Shadow's Edge only.
App + Guide Group: Participants used Shadow's Edge and completed exercises from the GSEA.
Control Group (Waitlist): Participants received delayed access to both tools after a second baseline measurement.
Data were collected using three validated instruments:
- WHO-5 Well-Being Index (Campo-Arias et al., 2015 - Colombian validation): Measures subjective well-being over the last two weeks using five items on a Likert scale.
- Abbreviated Resilience Scale (EAR) (Rodríguez-Rey et al., 2016 - Spanish validation): A six-item scale assessing perceived resilience.
- Abbreviated Resilient Coping Scale (EAAR) (Trejos-Herrera et al., 2023 - Colombian validation): A four-item scale measuring resilient coping behaviors.
Measurements were taken in person at baseline and at 4 and 8 weeks for the intervention groups. The control group was evaluated four times: twice prior to gaining access to the tools and twice after. All instruments were administered in print. Compliance with the app usage was monitored via daily digital progress logs and backend usage data linked to anonymous codes. Participants were encouraged to use the app for at least 20 minutes daily.
Statistical analysis was conducted using mixed-effects regression models in R, controlling for group assignment, age, sex, and the number of words written in the app journal (used as a proxy for engagement). The analysis aimed to determine changes over time in each outcome measure, as well as between-group differences.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| App only | Experimental | Behavioral: Shadow's Edge mobile appParticipants 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. |
| App + Guide | Experimental | Behavioral: Shadow's Edge mobile app, Behavioral: Guide to Self-Awareness (GSEA)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. |
| 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. |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shadow's Edge mobile appA mobile application adapted for Colombian youth that uses interactive storytelling, journaling, and emotional regulation activities to promote subjective well-being and resilience. | Behavioural | App + Guide, App only |
| Guide to Self-Awareness (GSEA)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. | Behavioural | App + Guide |
Primary outcome
Change in WHO-5 Well-Being Index Score
Time frame: 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.
2 secondary outcomes
Change in Abbreviated Resilience Scale (EAR) Score
Time frame: Baseline (Week 0), Week 4, and Week 8
Change in Abbreviated Resilient Coping Scale (EAAR) Score
Time frame: Baseline (Week 0), Week 4, and Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) related to primary and secondary outcomes (WHO-5, EAR, and EAAR scores), collected at all time points.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Orlando Scoppetta, Ph.D. study director
Fundación Centro Internacional de Educación y Desarrollo Humano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shadow's Edge mobile app and Guide to Self-Awareness (GSEA) in people with Mental Health Promotion and Subjective Well-Being, run by Fundación Centro Internacional de Educación y Desarrollo Humano at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in WHO-5 Well-Being Index Score (time frame: Baseline (Week 0), Week 4, and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.