Intervention on Socio-emotional Development and Well-being Through ICTs in Early Adulthood

NCT ID: NCT06049407

Last Updated: 2025-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

385 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2025-08-31

Brief Summary

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emoWELL is a serious game, that is, a video game designed to inform and train in skills and competencies in a more dynamic way. emoWELL focuses on understanding and developing healthy emotional regulation strategies to improve well-being.

Detailed Description

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Computer-based videogame. The program has a graphic adventure format, where the player controls an avatar who embarks on a train journey. Throughout this journey, the train will make five different stops where the player will learn about emotional regulation through activities or puzzles, readings and different interventions with the game's characters. At the first stop, the player will receive psychoeducation about emotional regulation and the most frequent adaptive and maladaptive regulation strategies. In the next three areas, exercises will be carried out to apply these strategies on variables such as self-esteem, self-care, stress, time management and social support. Finally, in the last area, the player will review the different contents learned. In addition to the train and the five stops or areas described, the game includes the area of the avatar's house and a final scenario that will vary depending on the player's answers throughout the adventure, in order to highlight the most important learning and conclude the game. Therefore, emoWELL consists of 8 areas in total.

The intervention is carried out autonomously. In addition to the computer game, emoWELL is linked to a mobile application so that the user can practice, integrate and reinforce the knowledge learned in the remote game, being both platforms indispensable in the intervention.

Conditions

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Emotion Regulation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental: Intervention group

Group Type EXPERIMENTAL

Participation in a socio-emotional competence program through a technological platform (EMOWELL)

Intervention Type BEHAVIORAL

(1) Participants who meet the inclusion criteria will be contacted. (2) Participants will answer the questionnaire battery (T1) (3) Participants will participate in the intervention by remotely playing the EMOWELL desktop serious game and the EMOWELL app. (4) They will answer the T2 questionnaires.

No Intervention: Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Participation in a socio-emotional competence program through a technological platform (EMOWELL)

(1) Participants who meet the inclusion criteria will be contacted. (2) Participants will answer the questionnaire battery (T1) (3) Participants will participate in the intervention by remotely playing the EMOWELL desktop serious game and the EMOWELL app. (4) They will answer the T2 questionnaires.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* To have signed the informed consent (or their legal tutors).
* Being between 18 and 29 years old.

Exclusion Criteria

* Inability to understand the activities or the language used.
Minimum Eligible Age

18 Years

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ministerio de Ciencia e Innovación, Spain

OTHER_GOV

Sponsor Role collaborator

University of Valencia

OTHER

Sponsor Role lead

Responsible Party

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Inmaculada Montoya Castilla

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Spain

Valencia, Valencian Comunity, Spain

Site Status

Countries

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Spain

References

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Velert-Jimenez S, Sanchez-Sanchez H, Perez-Marin M, Gil-Gomez JA, Montoya-Castilla I. Emotion regulation intervention to promote well-being through a serious game (emoWELL): a study protocol for a randomised controlled trial in Spanish emerging adults. BMJ Open. 2025 Jul 16;15(7):e098230. doi: 10.1136/bmjopen-2024-098230.

Reference Type DERIVED
PMID: 40669891 (View on PubMed)

Other Identifiers

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PID2020-114425RB

Identifier Type: -

Identifier Source: org_study_id

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