NCT06450730

Effectiveness of a Combined mHealth-CBT Psychological Intervention to Improve Psychological Well-Being in Young Patients With T1D

Effectiveness of a Combined mHealth Cognitive Behavioral Therapy Psychological Intervention to Improve Psychological Well-being in Young Patients With Type 1 Diabetes.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Maimónides Biomedical Research Institute of Córdoba · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

Type 1 diabetes (T1D) can lead to psychological adjustments that impact the acceptance and management of this health condition, as well as the overall quality of life of patients, especially among the young. Therefore, there is a need for psychological interventions aimed at enhancing the psychological well-being of children and adolescents with T1D. The goal of this non-randomized controlled trial is to evaluate whether a combined intervention comprising mHealth (using an app) and face-to-face psychological sessions based on Barlow's protocol and cognitive-behavioral therapy techniques (CBT) is effective in enhancing psychological well-being in children and adolescents with T1D. The main hypotheses are: * H1: The primary results expected to be obtained are a significant increase in psychological well-being, which means a decreased diabetes distress (DDS) (H1a) an increased subjective well-being (PANAS) (H1b) and a better self-efficacy for managing their emotions (RESE) (H1c). * H2: As secondary outcomes, it is also expected that the combined mHealth-CBT intervention would increase the level of positivity (P-Scale) (H2a), the self-esteem (RSES) (H2b) and the satisfaction with life (SWLS) (H2c).

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive-Behavioral Therapy: face-to-face + app	This group will receive three 1-hour face-to-face CBT sessions (1,3,8). Participants will be involved in psychoeducation and practical activities related to psychological variables crucial for the adequate management of the disease (emotion regulation, self-efficacy, psychological flexibility, decision-making, etc.). These activities will include role-playing, discussions, and assignments to highlight the importance of emotions, thoughts, and healthy behaviors in managing diabetes and and their impact on the quality of life. For the online sessions, an app will be developed to complement the face-to-face intervention. Participants will engage in 5-weeks of exercises with weekly activities related to the intervention content (2,5,6,7). The structure of the activities will mirror that of the face-to-face sessions and will include tasks, self-report instruments, reinforcement and activity monitoring. In addition, the app will incoportate multiple resources (texts, slides, videos).

Timeline

• Start date: 2023-02-11
• Primary completion: 2026-07-01
• Completion: 2026-09-01
• First posted: 2024-06-10
• Last updated: 2026-04-17

Locations

1 site across 1 country: Spain