Combined mHealth-CBT for psychological well-being in young people with Type 1 diabetes
Official title: Effectiveness of a Combined mHealth Cognitive Behavioral Therapy Psychological Intervention to Improve Psychological Well-being in Young Patients With Type 1 Diabetes.
Run by Maimónides Biomedical Research Institute of Córdoba · NCT06450730 · Data updated 2026-11-12
This trial tests a mix of an app-based mHealth program plus in-person CBT sessions to see if it improves psychological well-being for children and teens with Type 1 diabetes.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 18 Years |
| Sex | All |
| Enrollment | 122 (estimated) |
| Sponsor | Maimónides Biomedical Research Institute of Córdoba Academic / other |
| Locations | 1 site (Córdoba, Córdoba) |
| Status | Recruiting |
| Started | February 11, 2023 |
| Main results expected | December 2026 |
| Study ends | April 2027 |
| Registry record updated | October 13, 2026 |
| Trial ID | NCT06450730 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are youths aged 6-18 with Type 1 diabetes who own a compatible smartphone, have internet access, and are willing to participate in both app-based and in-person CBT sessions.
✕Probably not a fit
Participants without access to a compatible smartphone or internet, or those not seeking psychological support, may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This non-randomized study evaluates whether a combined intervention using a mobile app and face-to-face cognitive-behavioral therapy can improve psychological well-being in youths aged 6 to 18 with Type 1 diabetes. The approach follows a CBT framework integrated with mHealth tools to support emotion regulation and diabetes distress reduction. Outcomes focus on psychological well-being measures, including diabetes distress, positive affect, and self-efficacy for managing emotions. Participants need a compatible smartphone and internet access, and must not be enrolled in other psychological trials. The study is led by Maimónides Biomedical Research Institute of Córdoba with the Universidad de Córdoba, at Reina Sofía University Hospital in Córdoba, Spain.
Why it matters
Potential benefit: If successful, participants may experience reduced diabetes-related distress and improved emotional well-being.
How similar studies have gone: Previous similar approaches using CBT and digital tools have shown promise in improving psychological outcomes in chronic disease populations, though exact results vary by setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Reina Sofía University Hospital
Córdoba, Córdoba, Spain Recruiting
Study contacts
- Principal investigator: Bárbara Luque, PhD — Universidad de Córdoba
- Study coordinator: Rosario Castillo-Mayén, PhD
- Email: rcmayen@uco.es
- Phone: +34 957218923
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.