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

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).

NCT Number	NCT06450730
Lead Sponsor	Maimónides Biomedical Research Institute of Córdoba Collaborators: Universidad de Córdoba
Conditions	Diabetes Mellitus, Type 1
Enrollment	122 participants
Start Date	2023-02-11
Primary Completion	2026-07 (estimated)
Study Completion	2026-09 (estimated)
Updated on ClinicalTrials.gov	2026-04-17