Clinical trial NCT06450730: Effectiveness of a Combined mHealth-CBT Psychological Intervention to Improve Psychological Well-Being in Young Patients With T1D
Official title: Effectiveness of a Combined mHealth Cognitive Behavioral Therapy Psychological Intervention to Improve Psychological Well-being in Young Patients With Type 1 Diabetes.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Type 1 Diabetes
Cognitive-behavioral Therapy
mHealth interventions
Psychological well-being
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
Collaborators: name: Universidad de Córdoba
First posted: 2024-06-10
Enrollment: 122
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility 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

Primary outcomes:
measure: Diabetes Distress
timeFrame: Baseline, immediately after intervention and four months later (follow-up)
measure: Regulatory Emotional Self-Efficacy
timeFrame: Baseline, immediately after intervention and four months later (follow-up)
measure: Positive Affect and Negative Affect
timeFrame: Baseline, immediately after intervention and four months later (follow-up)
Secondary outcomes:
measure: Positivity
timeFrame: Baseline, immediately after intervention and four months later (follow-up)
measure: Self-esteem
timeFrame: Baseline, immediately after intervention and four months later (follow-up)
measure: Satisfaction with Life
timeFrame: Baseline, immediately after intervention and four months later (follow-up)
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Reina Sofía University Hospital
Study officials:
affiliation: Universidad de Córdoba
name: Bárbara Luque, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Salamanca
name: Carmen Tabernero, PhD
role: PRINCIPAL_INVESTIGATOR
References: