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Evaluation of the Effectiveness of a Program of Emotional Intelligence in Adolescents With Type 1 Diabetes (INTEDI) (INTEDI)

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ClinicalTrials.gov Identifier: NCT03734367
Recruitment Status : Recruiting
First Posted : November 8, 2018
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
Desiree Ruiz Aranda, Universidad Loyola Andalucia

Brief Summary:
Type 1 Diabetes Mellitus is one of the main health problems of the pediatric population worldwide, being one of the most frequent chronic endocrinology diseases in childhood and adolescence. It is a chronic degenerative disease that requires changes in the habits of life, which greatly influences the psychological functioning of those who suffer from it. Emotional factors play an important role in the control of diabetes. Specifically, emotional activation in response to different emotions such as stress, is considered one of the main factors involved in the destabilization of metabolic control in diabetes. The purpose of the study is to assess whether the introduction of a program for the development of emotional skills produces an increase in the emotional management of patients and examine whether these abilities are associated with better metabolic control measured by glycosylated hemoglobin (HbA1c), better healthy lifestyle habits and greater emotional well-being in adolescents with type 1 diabetes.This is an interventional study with two arms: 1) a control group and 2) an intervention group. The present work aims to offer a new intervention tool focused on the processing of emotional information to work the unpleasant emotions associated with this disease. The program will be designed following the Emotional Intelligence model of authors Mayer and Salovey and will focus on the development of emotional skills and knowledge that will help adolescents to promote healthy habits and improve their quality of life. The main objective of the program is to contribute to improving the knowledge and abilities of perception, assimilation, understanding and intra and interpersonal emotional regulation. The expected outcomes of the research are related to improvements in clinical practice. Increasing emotional skills of patients with diabetes can contribute to improving their quality of life and well-being. The expected results of this research will provide professionals with tools that will enable greater guarantees in adherence to treatment by patients. These results could lead to a utility model, introducing an assistance model different from the usual practice that introduces the intervention in emotional skills in the management of pediatric diabetic patients. In addition, this intervention could have an impact not only on the psychological components of the patient but also on metabolic changes and life habits.

Condition or disease Intervention/treatment Phase
Type1 Diabetes Mellitus Behavioral: Emotional abilities training program Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Intervention in Emotional Intelligence in Adolescents With Type 1 Diabetes Mellitus
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Active Comparator: Emotional abilities training program
Intervention program on emotional abilities that will be carried out for 10 hours distributed over 5 weeks, in two and a half hour session. The work methodology will be eminently practical, working in groups including real case analysis and interactive simulation
Behavioral: Emotional abilities training program
A randomized controlled trial that evaluates the effectiveness of a program of emotional skills on metabolic control to be assessed through the glycosylated hemoglobin (HbA1c), healthy lifestyle habits and wellbeing in adolescents with type 1, Diabetes Mellitus

No Intervention: Control group
Control group that will not receive the training program on emotional abilities but usual care.



Primary Outcome Measures :
  1. Change in emotional skills of adolescents with type 1 diabetes related to a greater emotional regulation [ Time Frame: Pre-test (before intervention), post-test (after the intervention; month 6 and month 12) ]

    Participants will be asked to complete a battery of psychological questionnaires

    -Difficulties in Emotion Regulation Scale (DERS) This is a 28-item, self-report questionnaire measuring clinically relevant difficulties in emotion regulation. In the Spanish adaptation, the items are grouped into five subscales: impulse control difficulties, non-acceptance of emotional response, difficulties engaging in goal-directed behavior, lack of emotional awareness and lack of emotional clarity. Subscales are scored on a 5-point scale ranging from 1 (never) to 5 (always). Higher scores indicate greater difficulty with emotion regulation. This scale has been shown to have adequate psychometric properties.


  2. Change in emotional skills of adolescents with type 1 diabetes related to less stress levels [ Time Frame: Pre-test (before intervention), post-test (after the intervention; month 6 and month 12) ]

    Participants will be asked to complete a battery of psychological questionnaires

    -The Diabetes Distress Scale (DDS-17). It assesses the emotional distress associated with diabetes and it includes four dimensions: emotional burden, physician-related distress, regimen-related distress, and diabetes-related interpersonal distress. Higher scores indicate greater stress related to disease. This scale has been shown to have adequate internal consistency and validity. Cronbach's alpha ranged from 0.88 to 0.93


  3. Change in emotional skills of adolescents with type 1 diabetes related to a greater positive affect [ Time Frame: Pre-test (before intervention), post-test (after the intervention; month 6 and month 12) ]

    Participants will be asked to complete a battery of psychological questionnaires

    -Positive and Negative Affect Schedule (PANAS). It is a self-reported adjective checklist that contains two 20-item subscales designed for the assessment of positive and negative affect. Respondents use a 5-point Likert scale to rate the extent to which they usually feel each of 20 emotion-related words. Reliability and validity reported by Watson and colleagues was moderately good. Cronbach's alpha ranged from 0.87 to 0.90.


  4. Change in emotional skills of adolescents with type 1 diabetes related to an increase in healthy life habits [ Time Frame: Pre-test (before intervention), post-test (after the intervention; month 6 and month 12) ]

    Participants will be asked to complete a battery of psychological questionnaires

    -eVITAL toolkit8. Adaptation of the Macrodomain Diet and Exercise 4.1 Domain diet and nutrition and 4.2. Domain exercise eVITAL toolkit for measuring healthy habits in diabetes.


  5. Change in emotional skills of adolescents with type 1 diabetes related to a greater perception of quality of life [ Time Frame: Pre-test (before intervention), post-test (after the intervention; month 6 and month 12) ]

    Participants will be asked to complete a battery of psychological questionnaires

    -The PedsQL 4.0 Generic Core Scales. The 23-item PedsQL 4.0 Generic Core Scales comprise four multi-item scales that explore dimensions of health-related quality of life: 1) physical functioning (8 items), 2) emotional functioning (5 items), 3) social functioning (5 items), and 4) school functioning (5 items). Respondents use a 5-point Likert scale. Higher scores indicate greater quality of life.


  6. Change in the emotional skills of adolescents with type 1 diabetes that will be related to a glycosylated index between normal values [ Time Frame: Pre-test (before intervention), post-test (after the intervention; month 6 and month 12) ]

    Metabolic variables will be assessed using a flash glucose monitoring (FGM) device.

    Glycemic control. Participants report their HbA1c level from their last blood test. The American Diabetes Association recommends a target HbA1c of 7.5% for children and adolescents. Moreover, mean glucose, standard deviation, percentage of glucose in normoglycemia (time in range, according to individualized target), percent of time in hypoglycemia (below 70) and percent of time in hyperglycemia (according to an individualized target), and number of hypoglycemic episodes will be collected. Variables will be analyzed from the last 15 days prior to evaluation. Metabolic variables will be obtained using a flash glucose monitoring (FMG) device (Free Style Libre) as it has become the standard glucose monitoring system in the Andalusian Public Health System for the pediatric population. For non-FMG users, metabolic variables will be obtained by glucometers through their specific software.




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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a diagnosis of type 1 Diabetes Mellitus for at least 12 months.
  • Type of treatment, International Unit insulin/kg

Exclusion Criteria:

  • Present some incapacitating psychiatric disorder or other chronic illness.
  • Not giving informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03734367


Contacts
Contact: Desrieé Ruiz, Psychologist 0034955641600 ext 545 daruiz@uloyola.es

Locations
Spain
Hospital Universitario Virgen Macarena Recruiting
Sevilla, Spain, 41009
Contact: María Asunción Martínez Brocca, Physician         
Sponsors and Collaborators
Universidad Loyola Andalucia
Investigators
Principal Investigator: Desireé Ruiz, Psychologist Universidad Loyola Andalucía

Publications of Results:
Other Publications:
Responsible Party: Desiree Ruiz Aranda, Doctor, Universidad Loyola Andalucia
ClinicalTrials.gov Identifier: NCT03734367     History of Changes
Other Study ID Numbers: ULoyolaAndalucia
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Desiree Ruiz Aranda, Universidad Loyola Andalucia:
Emotional Intelligence
HbA1c
Healthy habits
Type 1 Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases