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

Maimónides Biomedical Research Institute of Córdoba

Status

Active, not recruiting

Conditions

Diabetes Mellitus, Type 1

Treatments

Behavioral: Cognitive-Behavioral Therapy: face-to-face + app

Study type

Interventional

Funder types

Other

Identifiers

NCT06450730

PDI2019-107304RB-I00-BLS-T1D

Details and patient eligibility

About

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).

Enrollment

122 patients

Sex

All

Ages

6 to 18 years old

Volunteers

No Healthy Volunteers

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