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

NCT ID: NCT06450730

Last Updated: 2024-06-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-11
• Study Completion Date: 2025-06-30

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).

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CBT face-to-face + app

Combines face-to-face CBT sessions with online activities and resources trough a mobile app

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

This group will receive three 1-hour face-to-face CBT sessions (1,3,8). Participants will be involved in psychoeducation and practical activities related to psychological variables crucial for the adequate management of the disease (emotion regulation, self-efficacy, psychological flexibility, decision-making, etc.). These activities will include role-playing, discussions, and assignments to highlight the importance of emotions, thoughts, and healthy behaviors in managing diabetes and and their impact on the quality of life.

For the online sessions, an app will be developed to complement the face-to-face intervention. Participants will engage in 5-weeks of exercises with weekly activities related to the intervention content (2,5,6,7). The structure of the activities will mirror that of the face-to-face sessions and will include tasks, self-report instruments, reinforcement and activity monitoring. In addition, the app will incoportate multiple resources (texts, slides, videos).

TAU Group

TAU Group Patients of the control group continued their usual treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

This group will receive three 1-hour face-to-face CBT sessions (1,3,8). Participants will be involved in psychoeducation and practical activities related to psychological variables crucial for the adequate management of the disease (emotion regulation, self-efficacy, psychological flexibility, decision-making, etc.). These activities will include role-playing, discussions, and assignments to highlight the importance of emotions, thoughts, and healthy behaviors in managing diabetes and and their impact on the quality of life.

For the online sessions, an app will be developed to complement the face-to-face intervention. Participants will engage in 5-weeks of exercises with weekly activities related to the intervention content (2,5,6,7). The structure of the activities will mirror that of the face-to-face sessions and will include tasks, self-report instruments, reinforcement and activity monitoring. In addition, the app will incoportate multiple resources (texts, slides, videos).

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Córdoba

OTHER

Sponsor Role: collaborator

Maimónides Biomedical Research Institute of Córdoba

OTHER

Sponsor Role: lead

Responsible Party

Rosario Castillo-Mayén

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bárbara Luque, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Córdoba

Carmen Tabernero, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Salamanca

Locations

Reina Sofía University Hospital

Córdoba, , Spain

Countries

Spain

Other Identifiers

PDI2019-107304RB-I00-BLS-T1D

Identifier Type: -

Identifier Source: org_study_id