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

NCT06450730 | Active Not Recruiting

• 1 other identifier: PDI2019-107304RB-I00-BLS-T1D
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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

Keywords

Type 1 Diabetes; Cognitive-behavioral Therapy; mHealth interventions; Psychological well-being

Outcome Measures

Primary Outcomes (3)

• Diabetes Distress

  Diabetes Distress Scale (DDS; Polonsky et al., 2005) is a Likert-type scale of 17 items that measures the level of emotional distress related to diabetes in individuals living with this chronic condition and how it impacts their quality of life. Scores ranges from 1 "not a problem" to 5 "very serious problem".

  Baseline, immediately after intervention and four months later (follow-up)

• Regulatory Emotional Self-Efficacy

  Regulatory Emotional Self-Efficacy scale (RESE; Caprara \& Gervino, 2001).It is designed to assess an individual's perceived self-efficacy in managing negative and expressing positive emotions. It is a five-point scale (1 = not capable at all; 5 = completely capable) to 12 items distributed across two factors: positive affect expression (4 items) and negative affect expression, further divided into handling dejection and distress (4 items), and handling anger and irritation (4 items).

  Baseline, immediately after intervention and four months later (follow-up)

• Positive Affect and Negative Affect

  Positive Affect and Negative Affect Scale (PANAS; Watson et al., 1988) It is a Likert-type scale of 20-item (10 items for positive and 10 items for negative affect, that assesses the extent to which the participants experienced positive affect in the last 2 weeks. Rated on a 5-point scale from 1 "not at all" to 5 "very much". It has been validated in Spanish (López-Gomez, et al., 2015)

  Baseline, immediately after intervention and four months later (follow-up)

Secondary Outcomes (3)

• Positivity

  Baseline, immediately after intervention and four months later (follow-up)

• Self-esteem

  Baseline, immediately after intervention and four months later (follow-up)

• Satisfaction with Life

  Baseline, immediately after intervention and four months later (follow-up)

Study Arms (2)

CBT face-to-face + app

EXPERIMENTAL

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

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

TAU Group

NO INTERVENTION

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

Interventions

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

CBT face-to-face + app

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead
• Universidad de Córdoba: collaborator

Study Sites (1)

Reina Sofía University Hospital

Córdoba, Córdoba, 14004, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Psychological Well-Being

Interventions

Amyloid

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Bárbara Luque, PhD

  Universidad de Córdoba

  PRINCIPAL INVESTIGATOR

• Carmen Tabernero, PhD

  University of Salamanca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 10, 2024
• Study Start: February 11, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

ES (1)