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Active (not recruiting) Not applicable NCT06450730

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

No applicable phase (e.g. observational)
Conditions: Diabetes Mellitus, Type 1

Sponsor: Maimónides Biomedical Research Institute of Córdoba

trial.available_in: БГ
Overview
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).
Who can participate
Inclusion Criteria: * Girls and Boys with a diagnosis of T1D 6 - 18 * Having a smartphone compatible with the APP created used for the mHealth intervention and daily access to internet * Having the required digital skills to follow the mHealth intervention * Not currently participating in another clinical trial involving a psychological intervention Exclusion Criteria: * Girls and Boys with a diagnosis of T1D \>18 years * Not Having a smartphone compatible with the APP created used for the mHealth intervention and daily access to internet * Currently participating in another clinical trial involving a psychological intervention
Interventions
Cognitive-Behavioral Therapy: face-to-face + app
BEHAVIORAL
Locations 1
Spain (1)
Reina Sofía University Hospital
Córdoba , Córdoba
Technical details
Status
Active (not recruiting)
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
6 Years
Maximum age
18 Years
Healthy volunteers
No
Start date
11.02.2023
Completion date
01.09.2026
Registry ID
NCT06450730
Source
clinicaltrials.gov
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