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

Emotion Regulation Clinical Trial

— EMOWELL  

Official title:

Intervention Through an Intelligent Technological Platform for Social-emotional Development and the Promotion of Well-being in Adolescence and Early Adulthood

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06049407
• Other study ID #: PID2020-114425RB
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: August 31, 2025

Study information

• Verified date: September 2023
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 29 Years

Eligibility

Inclusion Criteria:

• To have signed the informed consent (or their legal tutors).

• Being between 16 and 29 years old.

Exclusion Criteria:

• Inability to understand the activities or the language used.

Related Conditions & MeSH terms

• Emotion Regulation

Intervention

Behavioral:
• 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. (5) They will answer the follow-up (T3) questionnaires.

Locations

Country	Name	City	State
Spain	Spain	Valencia	Valencian Comunity

Sponsors (2)

Lead Sponsor	Collaborator
University of Valencia	Ministerio de Ciencia e Innovación, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Time 1 (first month)
Primary	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.	Time 2 (4th month)
Primary	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.	Time 3 (up to 1 year)
Primary	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.	Time 1 (first month)
Primary	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.	Time 2 (4th month)
Primary	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.	Time 3 (up to 1 year)
Primary	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.	Time 1 (first month)
Primary	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.	Time 2 (4th month)
Primary	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.	Time 3 (up to 1 year)
Primary	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.	Time 1 (first month)
Primary	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.	Time 2 (4th month)
Primary	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.	Time 3 (up to 1 year)
Secondary	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.	Time 1 (first month)
Secondary	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.	Time 2 (4th month)
Secondary	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.	Time 3 (up to 1 year)
Secondary	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.	Time 1 (first month)
Secondary	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.	Time 2 (4th month)
Secondary	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.	Time 3 (up to 1 year)
Secondary	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.	Time 1 (first month)
Secondary	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.	Time 2 (4th month)
Secondary	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.	Time 3 (up to 1 year)
Secondary	''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.	Time 1 (first month)
Secondary	''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.	Time 2 (4th month)
Secondary	''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.	Time 3 (up to 1 year)