Emoticare: Serious Game for the Adaptation to the Disease of Adolescents With Type 1 Diabetes Mellitus.

NCT ID: NCT06331429

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-22
• Study Completion Date: 2025-03-31

Brief Summary

The intervention program targets adolescents with chronic Type 1 Diabetes Mellitus. Given the critical developmental stage and life transitions, necessitating robust personal resources, psychological support becomes imperative. To foster socioemotional skills and overall well-being, particularly crucial for averting future emotional issues and promoting a healthier, more fulfilling life, this support is especially vital for those dealing with chronic illnesses. Such conditions pose a risk for psychological problems, potentially complicating treatment and prognosis. Presently, digital and technological platforms are integrating psychological interventions for patients with chronic diseases, showcasing an innovative approach to address psychological challenges.

The platform integrates new technologies for assessment and intervention. Ecological Momentary Assessment enables real-time evaluation, with data transferred to the technological platform. Artificial intelligence personalizes interventions based on participants' socio-demographic characteristics and assessment results. Ecological Momentary Intervention is employed for in-context treatments in participants' daily lives and natural environments. A serious game method, proven effective in various interventions, is used to engage adolescents and young people intrinsically. The game encompasses six main areas aligning with theoretical models, facilitating the development of socio-emotional competencies, and promoting physical and psychological health. It addresses different aspects of psychological and subjective well-being, reinforcing resources needed to navigate vital changes in these developmental stages, especially when living with a chronic illness.

Conditions

Type 1 Diabetes; Adolescent Development

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control Group

Patients who receive the treatment program, will previously constitute their own control group (waiting list control group).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental group

Adolescents who receive the treatment program, will previously constitute their own control group (waiting list control group). Thus, diagnostic measures will be obtained in all of them in an initial evaluation (T1), and after 6 weeks of this assessment the treatment program will be started. In the first contact session at 6 weeks after T1 all adolescents will be re-assessed (T2) and after this the treatment program will be started (within an estimated time of 15 days maximum from this second pre-treatment evaluation, the estimated duration of treatment being 6 weeks). After the completion of the serious game, a new asssesment pass will be performed (T3) in order to assess the post-treatment change. Thus, the estimated time between T2 and T3 will be equivalent to that between T1 and T2, being 6 weeks.

Group Type: EXPERIMENTAL

EmoTiCare

Intervention Type: BEHAVIORAL

The EMOTICARE technological platform intervenes in users through a serious game, i.e. a video game whose main purpose is to teach or provide the player with certain skills that serve to achieve a higher purpose than the game itself.

The game works in 6 areas, each of which refers to one of the variables that are analysed or considered important in the adaptation to the disease: Area 1. Psychoeducation of DM1; 2. Emotional awareness and expression; 3. Emotional regulation; 4. Problem solving; 5. Self-esteem and identity;6. Social skills and communication

Interventions

EmoTiCare

The EMOTICARE technological platform intervenes in users through a serious game, i.e. a video game whose main purpose is to teach or provide the player with certain skills that serve to achieve a higher purpose than the game itself.

The game works in 6 areas, each of which refers to one of the variables that are analysed or considered important in the adaptation to the disease: Area 1. Psychoeducation of DM1; 2. Emotional awareness and expression; 3. Emotional regulation; 4. Problem solving; 5. Self-esteem and identity;6. Social skills and communication

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Diagnosis of Diabetes mellitus type 1 (6 months from diagnosis)
• Informed consent by parents/guardians and participants

Exclusion Criteria

• Diagnosis other than type 1 diabetes mellitus
• No access to internet or new technologies
• Not speaking Spanish

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitat Politècnica de València

OTHER

Sponsor Role: collaborator

University of Valencia

OTHER

Sponsor Role: lead

Responsible Party

M. Antonia Pérez-Marín

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marián Pérez-Marín, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Valencia

Locations

Universitat de València

Valencia, , Spain

Countries

Spain

References

Martin-Avila J, Rodriguez-Jimenez E, Valero-Moreno S, Gil-Gomez JA, Montoya-Castilla I, Perez-Marin M. The impact of the emoTICare program on socioemotional adjustment and psychological well-being in adolescents with type 1 diabetes mellitus. Front Endocrinol (Lausanne). 2025 Oct 3;16:1668398. doi: 10.3389/fendo.2025.1668398. eCollection 2025.

Reference Type: DERIVED

PMID: 41113700 (View on PubMed)

Other Identifiers

EmoTiCare

Identifier Type: -

Identifier Source: org_study_id