Effectiveness of a Combined mHealth-CBT Psychological Intervention to Improve Psychological Well-Being in Young Patients With T1D
- Conditions
- Diabetes Mellitus, Type 1
- Registration Number
- NCT06450730
- Lead Sponsor
- Maimónides Biomedical Research Institute of Córdoba
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 122
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Diabetes Distress Baseline, immediately after intervention and four months later (follow-up) 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".
Positive Affect and Negative Affect Baseline, immediately after intervention and four months later (follow-up) 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)
Regulatory Emotional Self-Efficacy Baseline, immediately after intervention and four months later (follow-up) 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).
- Secondary Outcome Measures
Name Time Method Positivity Baseline, immediately after intervention and four months later (follow-up) 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".
Self-esteem Baseline, immediately after intervention and four months later (follow-up) 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".
Satisfaction with Life Baseline, immediately after intervention and four months later (follow-up) 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".
Trial Locations
- Locations (1)
Reina Sofía University Hospital
🇪🇸Córdoba, Spain