NCT06450730Recruiting
Effectiveness of a Combined mHealth-CBT Psychological Intervention to Improve Psychological Well-Being in Young Patients With T1D
Effectiveness of a Combined mHealth Cognitive Behavioral Therapy Psychological Intervention to Improve Psychological Well-being in Young Patients With Type 1 Diabetes.
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 122 (estimated)
- First submitted
- 5 Jun 2024
- Start date
- 11 Feb 2023
- Primary completion date
- Dec 2026
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Diseases
- Type 1 diabetes
- NCT number
- NCT06450730
What you commit to
- Study type: Interventional
- Planned participants: 122
- From 11 Feb 2023 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Girls and Boys with a diagnosis of T1D \>18 years
Other
- 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
Who the study is looking for
- 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
Age in the registry: 6 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Reina Sofia University Hospital Coordinator of this site? Confirm its status | Córdoba | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.