Combined app and face-to-face therapy for well-being in young people with type 1 diabetes
Tests a combined app and in-person therapy for children and teens with type 1 diabetes.
Plain-language title generated from the registry record
Registry title: Effectiveness of a Combined mHealth-CBT Psychological Intervention to Improve Psychological Well-Being in Young Patients With T1D
Key facts
- Where
- Córdoba, SpainSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 18 years old?
Source: NCT06450730, who can take part
Where in Spain
- Reina Sofia University HospitalCórdoba, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Maimónides Biomedical Research Institute of Córdoba
- Trial code
- NCT06450730
- Record updated
- 13 October 2026
- Original description
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:Read full original descriptionShow less
Effectiveness of a Combined mHealth Cognitive Behavioral Therapy Psychological Intervention to Improve Psychological Well-being in Young Patients With Type 1 Diabetes.
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).
Inclusion: 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: 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.