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

StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 4 months later Jul 2026 → Dec 2026
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Record History

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  1. Enrollment reopened Show 5 more changesShow less
    • Primary completion pushed from Jul 2026 to Dec 2026
    • Study completion pushed from Sep 2026 to Apr 2027
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 3 of 3 entries
    • Site details revised
  2. Primary completion date: May 25, 2025 to Jul 2026
    • Study completion date: Jun 30, 2025 to Sep 2026
    • Site details revised
    v2
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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).
Trial Details
NCT Number NCT06450730
Lead Sponsor Maimónides Biomedical Research Institute of Córdoba
Collaborators: Universidad de Córdoba
Conditions
(from sponsor)		 Diabetes Mellitus, Type 1
Related terms Diabetes Mellitus, Type 1, Psychological Well-Being
Enrollment 122 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov