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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Effectiveness of a Combined mHealth Cognitive Behavioral Therapy Psychological Intervention to Improve Psychological Well-being in Young Patients With Type 1 Diabetes.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06450730
• Other study ID #: PDI2019-107304RB-I00-BLS-T1D
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 11, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2024
• Source: Maimónides Biomedical Research Institute of Córdoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 122
• Est. completion date: June 30, 2025
• Est. primary completion date: May 25, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

Behavioral:
• 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).

Locations

Country	Name	City	State
Spain	Reina Sofía University Hospital	Córdoba

Sponsors (2)

Lead Sponsor	Collaborator
Maimónides Biomedical Research Institute of Córdoba	Universidad de Córdoba

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Positivity	The Positivity Scale (P Scale; Zuffianò et al., 2019) evaluates the predisposition of people to estimate their life and their experiences from a positive perspective. It is an 8-item Likert-type scale, ranging from 1 "completely false" to 5 "completely true".	Baseline, immediately after intervention and four months later (follow-up)
Secondary	Self-esteem	Rosenberg self-esteem scale (RSES; Rosenberg, 1965). The RSES is a10-item scale that measures global self-worth by measuring both positive and negative feelings about the self. The scale is believed to be uni-dimensional. All items are answered using a 4-point Likert scale format ranging from 1 "strongly disagree" to 5 "strongly agree".	Baseline, immediately after intervention and four months later (follow-up)
Secondary	Satisfaction with Life	Satisfaction with Life Scale (SWLS, Diener et al., 1985; Spanish adaptation by Atienza et al., 2000). The SWLS employs a 7-point Likert-style response scale with 5 items, ranging from 1 "completely disagree" to 5 "totally agree".	Baseline, immediately after intervention and four months later (follow-up)