Emotion RegulationEMOWELLNCT06049407
Intervention on Socio-emotional Development and Well-being Through ICTs in Early Adulthood
A study testing Participation in a socio-emotional competence program through a technological platform (EMOWELL) in people with Emotion Regulation, run by University of Valencia at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotion Regulation
- What is being tested?
- Participation in a socio-emotional competence program through a technological platform (EMOWELL)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 385 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2021to 31 Aug 2025
- 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 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- To have signed the informed consent (or their legal tutors).
- Being between 18 and 29 years old.
Who cannot join
- Inability to understand the activities or the language used.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intervention Through an Intelligent Technological Platform for Social-emotional Development and the Promotion of Well-being in Adolescence and Early Adulthood
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.
Read the detailed description
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
- Emotion Regulation
- Being tested
- Participation in a socio-emotional competence program through a technological platform (EMOWELL)
- Keywords
- young adulthood, emotional Intelligence, well-being, Information and Communication Technologies (ICT)
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participation in a socio-emotional competence program through a technological platform (EMOWELL)Behavioural
(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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Intervention group | Experimental | Not described Receives: Behavioral: Participation in a socio-emotional competence program through a technological platform (EMOWELL) |
| No Intervention: Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inventory of the Dimensions of Emerging Adulthood (IDEA-S)
The Spanish version is composed of 31 items. It is answered using a Likert scale from 1 (strongly disagree) to 3 (strongly agree). A higher score on a scale means a greater presence of these categories in the stage. It assesses the different characteristics of emerging adulthood: identity exploration, experimentation/possibilities, negativity/instability, other-centered, self-centered, feeling in between.
Measured: Time 1 (first month)
Inventory of the Dimensions of Emerging Adulthood (IDEA-S)
The Spanish version is composed of 31 items. It is answered using a Likert scale from 1 (strongly disagree) to 3 (strongly agree). A higher score on a scale means a greater presence of these categories in the stage. It assesses the different characteristics of emerging adulthood: identity exploration, experimentation/possibilities, negativity/instability, other-centered, self-centered, feeling in between.
Measured: Time 2 (4th month)
Difficulties in Emotion Regulation Scale (DERS)
The Spanish version is composed of 28 items. It is answered using a Likert scale from 1 (hardly ever) to 5 (almost always). This scale assesses difficulties associated of the emotion regulation process: emotional lack of control, life interference, lack of emotional attention, emotional confusion, and emotional rejection. Therefore, a higher score within each scale signals more difficulties in emotional regulation.
Measured: Time 1 (first month)
Difficulties in Emotion Regulation Scale (DERS)
The Spanish version is composed of 28 items. It is answered using a Likert scale from 1 (hardly ever) to 5 (almost always). This scale assesses difficulties associated of the emotion regulation process: emotional lack of control, life interference, lack of emotional attention, emotional confusion, and emotional rejection. Therefore, a higher score within each scale signals more difficulties in emotional regulation.
Measured: Time 2 (4th month)
Emotion Regulation Questionnaire (ERQ)
The scale is composed by 10 items. It is answered using a 7-point Likert scale.
Measured: Time 1 (first month)
Emotion Regulation Questionnaire (ERQ)
The scale is composed by 10 items. It is answered using a 7-point Likert scale.
Measured: Time 2 (4th month)
Cognitive Emotion Regulation Questionnaire (CERQ-18)
The instrument assesses cognitive strategies for emotional regulation. The version of the instrument used consists of 18 items and has five polytomous response options ranging from almost never (1) to always (5). The items are grouped into nine strategies: Rumination, Catastrophizing, Self-blaming, Blaming others, Putting in perspective, Acceptance, Positive focus, Positive reinterpretation, and Refocusing on plans; at a rate of two items per strategy.
Measured: Time 1 (first month)
Cognitive Emotion Regulation Questionnaire (CERQ-18)
The instrument assesses cognitive strategies for emotional regulation. The version of the instrument used consists of 18 items and has five polytomous response options ranging from almost never (1) to always (5). The items are grouped into nine strategies: Rumination, Catastrophizing, Self-blaming, Blaming others, Putting in perspective, Acceptance, Positive focus, Positive reinterpretation, and Refocusing on plans; at a rate of two items per strategy.
Measured: Time 2 (4th month)
Psychological Well-Being Scales (PWBS)
The Spanish version is composed of 29 items. It is answered using a Likert scale from 1 (totally agree) to 6 (totally disagree).
A higher score on each scale indicates higher levels in the resulting dimensions of psychological well-being:
Self-acceptance, Positive relationships, Autonomy, Environmental mastery, Purpose in life and Personal growth.
Measured: Time 1 (first month)
Psychological Well-Being Scales (PWBS)
The Spanish version is composed of 39 items. It is answered using a Likert scale from 1 (totally agree) to 6 (totally disagree).
A higher score on each scale indicates higher levels in the resulting dimensions of psychological well-being:
Self-acceptance, Positive relationships, Autonomy, Environmental mastery, Purpose in life and Personal growth.
Measured: Time 2 (4th month)
Secondary outcomes (8)
Rosenberg Self-Esteem Scale (RSE)
The RSE is an unidimensional instrument that consists of 10 items that assess self-esteem. Participants are asked to respond to each item using a four-point Likert scale ranging from "Strongly Disagree" to "Strongly Agree." A higher score indicates higher levels of self-esteem.
Measured: Time 1 (first month)
Rosenberg Self-Esteem Scale (RSE)
The RSE is an unidimensional instrument that consists of 10 items that assess self-esteem. Participants are asked to respond to each item using a four-point Likert scale ranging from "Strongly Disagree" to "Strongly Agree." A higher score indicates higher levels of self-esteem.
Measured: Time 2 (4th month)
Brief Symptom Inventory (BSI-18)
The instrument evaluates psychological distress, collected in three dimensions: anxiety, depression and somatization. It is composed of 18 items answered on a likert scale from 0 (Not at all) to 4 (Very much). Higher levels on each of these scales imply higher levels of anxiety, depression or somatization, respectively.
Measured: Time 1 (first month)
Brief Symptom Inventory (BSI-18)
The instrument evaluates psychological distress, collected in three dimensions: anxiety, depression and somatization. It is composed of 18 items answered on a likert scale from 0 (Not at all) to 4 (Very much). Higher levels on each of these scales imply higher levels of anxiety, depression or somatization, respectively.
Measured: Time 2 (4th month)
Three-item loneliness scale (TILS)
This scale evaluates the perception of loneliness. It is composed of three items answered on a Likert scale from 0 (Almost never) to 2 (Frequently). The higher the score, the greater the perception of loneliness.
Measured: Time 1 (first month)
Three-item loneliness scale (TILS)
This scale evaluates the perception of loneliness. It is composed of three items answered on a Likert scale from 0 (Almost never) to 2 (Frequently). The higher the score, the greater the perception of loneliness.
Measured: Time 2 (4th month)
''Optimism questionnaire'' (COP)
The last instrument presented is composed of 9 items. It evaluates the optimism of the participants. It is answered on a Likert scale from 1 to 5. A higher score implies higher levels of optimism.
Measured: Time 1 (first month)
''Optimism questionnaire'' (COP)
The last instrument presented is composed of 9 items. It evaluates the optimism of the participants. It is answered on a Likert scale from 1 to 5. A higher score implies higher levels of optimism.
Measured: Time 2 (4th month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start1 Sep 2021
- Primary completion31 Aug 2024
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emotion RegulationStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Ciencia e Innovación, Spain
- Responsible party
- Principal investigator, Inmaculada Montoya Castilla, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049407
- Sponsor's protocol ID
- PID2020-114425RB
- Acronym
- EMOWELL
- Status last verified
- Jun 2025
- First submitted
- 14 Jun 2023
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40669891
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Through an Intelligent Technological Platform for Social-emotional Development and the Promotion of Well-being in Adolescence and Early Adulthood
- ClinicalTrials.gov ID
- NCT06049407
- Acronym / sponsor ID
- EMOWELL / PID2020-114425RB
- Conditions
- Emotion Regulation
- Keywords
- young adulthood, emotional Intelligence, well-being, Information and Communication Technologies (ICT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Ministerio de Ciencia e Innovación, Spain
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 22 Sep 2023 (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.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Intervention group | Experimental | Behavioral: Participation in a socio-emotional competence program through a technological platform (EMOWELL) |
| No Intervention: Control group | No intervention | – |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- To have signed the informed consent (or their legal tutors).
- Being between 18 and 29 years old.
Key exclusion criteria (1 listed)
- Inability to understand the activities or the language used.
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 |
|---|---|---|
| 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. | Behavioural | Experimental: Intervention group |
Primary outcome
Inventory of the Dimensions of Emerging Adulthood (IDEA-S)
Time frame: Time 1 (first month)
The Spanish version is composed of 31 items. It is answered using a Likert scale from 1 (strongly disagree) to 3 (strongly agree). A higher score on a scale means a greater presence of these categories in the stage. It assesses the different characteristics of emerging adulthood: identity exploration, experimentation/possibilities, negativity/instability, other-centered, self-centered, feeling in between.
Inventory of the Dimensions of Emerging Adulthood (IDEA-S)
Time frame: Time 2 (4th month)
The Spanish version is composed of 31 items. It is answered using a Likert scale from 1 (strongly disagree) to 3 (strongly agree). A higher score on a scale means a greater presence of these categories in the stage. It assesses the different characteristics of emerging adulthood: identity exploration, experimentation/possibilities, negativity/instability, other-centered, self-centered, feeling in between.
Difficulties in Emotion Regulation Scale (DERS)
Time frame: Time 1 (first month)
The Spanish version is composed of 28 items. It is answered using a Likert scale from 1 (hardly ever) to 5 (almost always). This scale assesses difficulties associated of the emotion regulation process: emotional lack of control, life interference, lack of emotional attention, emotional confusion, and emotional rejection. Therefore, a higher score within each scale signals more difficulties in emotional regulation.
Difficulties in Emotion Regulation Scale (DERS)
Time frame: Time 2 (4th month)
The Spanish version is composed of 28 items. It is answered using a Likert scale from 1 (hardly ever) to 5 (almost always). This scale assesses difficulties associated of the emotion regulation process: emotional lack of control, life interference, lack of emotional attention, emotional confusion, and emotional rejection. Therefore, a higher score within each scale signals more difficulties in emotional regulation.
Emotion Regulation Questionnaire (ERQ)
Time frame: Time 1 (first month)
The scale is composed by 10 items. It is answered using a 7-point Likert scale.
Emotion Regulation Questionnaire (ERQ)
Time frame: Time 2 (4th month)
The scale is composed by 10 items. It is answered using a 7-point Likert scale.
Cognitive Emotion Regulation Questionnaire (CERQ-18)
Time frame: Time 1 (first month)
The instrument assesses cognitive strategies for emotional regulation. The version of the instrument used consists of 18 items and has five polytomous response options ranging from almost never (1) to always (5). The items are grouped into nine strategies: Rumination, Catastrophizing, Self-blaming, Blaming others, Putting in perspective, Acceptance, Positive focus, Positive reinterpretation, and Refocusing on plans; at a rate of two items per strategy.
Cognitive Emotion Regulation Questionnaire (CERQ-18)
Time frame: Time 2 (4th month)
The instrument assesses cognitive strategies for emotional regulation. The version of the instrument used consists of 18 items and has five polytomous response options ranging from almost never (1) to always (5). The items are grouped into nine strategies: Rumination, Catastrophizing, Self-blaming, Blaming others, Putting in perspective, Acceptance, Positive focus, Positive reinterpretation, and Refocusing on plans; at a rate of two items per strategy.
Psychological Well-Being Scales (PWBS)
Time frame: Time 1 (first month)
The Spanish version is composed of 29 items. It is answered using a Likert scale from 1 (totally agree) to 6 (totally disagree). A higher score on each scale indicates higher levels in the resulting dimensions of psychological well-being: Self-acceptance, Positive relationships, Autonomy, Environmental mastery, Purpose in life and Personal growth.
Psychological Well-Being Scales (PWBS)
Time frame: Time 2 (4th month)
The Spanish version is composed of 39 items. It is answered using a Likert scale from 1 (totally agree) to 6 (totally disagree). A higher score on each scale indicates higher levels in the resulting dimensions of psychological well-being: Self-acceptance, Positive relationships, Autonomy, Environmental mastery, Purpose in life and Personal growth.
8 secondary outcomes
Rosenberg Self-Esteem Scale (RSE)
Time frame: Time 1 (first month)
Rosenberg Self-Esteem Scale (RSE)
Time frame: Time 2 (4th month)
Brief Symptom Inventory (BSI-18)
Time frame: Time 1 (first month)
Brief Symptom Inventory (BSI-18)
Time frame: Time 2 (4th month)
Three-item loneliness scale (TILS)
Time frame: Time 1 (first month)
Three-item loneliness scale (TILS)
Time frame: Time 2 (4th month)
''Optimism questionnaire'' (COP)
Time frame: Time 1 (first month)
''Optimism questionnaire'' (COP)
Time frame: Time 2 (4th month)
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 30 Apr 2026.
- Derived from this study: PubMed 40669891Velert-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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participation in a socio-emotional competence program through a technological platform (EMOWELL) in people with Emotion Regulation, run by University of Valencia at 1 site in Spain.
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 2 inclusion and 1 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 30 Apr 2026. 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 Spain. 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?
Inventory of the Dimensions of Emerging Adulthood (IDEA-S) (time frame: Time 1 (first month)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06049407, which also lists 1 linked publication.
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 30 Apr 2026.