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

June 5, 2024 updated by: Rosario Castillo-Mayén, Maimónides Biomedical Research Institute of Córdoba

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Córdoba, Spain, 14004
        • Reina Sofia University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBT face-to-face + app
Combines face-to-face CBT sessions with online activities and resources trough a mobile app
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).
No Intervention: TAU Group
TAU Group Patients of the control group continued their usual treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetes Distress
Time Frame: 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".
Baseline, immediately after intervention and four months later (follow-up)
Regulatory Emotional Self-Efficacy
Time Frame: 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).
Baseline, immediately after intervention and four months later (follow-up)
Positive Affect and Negative Affect
Time Frame: 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)
Baseline, immediately after intervention and four months later (follow-up)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positivity
Time Frame: 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".
Baseline, immediately after intervention and four months later (follow-up)
Self-esteem
Time Frame: 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".
Baseline, immediately after intervention and four months later (follow-up)
Satisfaction with Life
Time Frame: 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".
Baseline, immediately after intervention and four months later (follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maimónides Biomedical Research Institute of Córdoba

Collaborators

Universidad de Córdoba

Investigators

  • Principal Investigator: Bárbara Luque, PhD, Universidad de Córdoba
  • Principal Investigator: Carmen Tabernero, PhD, University of Salamanca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2023

Primary Completion (Estimated)

May 25, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

June 5, 2024

First Submitted That Met QC Criteria

June 5, 2024

First Posted (Actual)

June 10, 2024

Study Record Updates

Last Update Posted (Actual)

June 10, 2024

Last Update Submitted That Met QC Criteria

June 5, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDI2019-107304RB-I00-BLS-T1D

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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