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

NCT03734367 | Unknown

• 1 other identifier: ULoyolaAndalucia
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Type1 Diabetes Mellitus

Keywords

Emotional Intelligence; HbA1c; Healthy habits; Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (6)

• Change in emotional skills of adolescents with type 1 diabetes related to a greater emotional regulation

  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.

  Pre-test (before intervention), post-test (after the intervention; month 6 and month 12)

• Change in emotional skills of adolescents with type 1 diabetes related to less stress levels

  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

  Pre-test (before intervention), post-test (after the intervention; month 6 and month 12)

• Change in emotional skills of adolescents with type 1 diabetes related to a greater positive affect

  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.

  Pre-test (before intervention), post-test (after the intervention; month 6 and month 12)

• Change in emotional skills of adolescents with type 1 diabetes related to an increase in healthy life habits

  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.

  Pre-test (before intervention), post-test (after the intervention; month 6 and month 12)

• Change in emotional skills of adolescents with type 1 diabetes related to a greater perception of quality of life

  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.

  Pre-test (before intervention), post-test (after the intervention; month 6 and month 12)

• Change in the emotional skills of adolescents with type 1 diabetes that will be related to a glycosylated index between normal values

  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.

  Pre-test (before intervention), post-test (after the intervention; month 6 and month 12)

Study Arms (2)

Emotional abilities training program

ACTIVE COMPARATOR

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

Control group

NO INTERVENTION

Control group that will not receive the training program on emotional abilities but usual care.

Interventions

Emotional abilities training program BEHAVIORAL

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

Emotional abilities training program

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad Loyola Andalucia: lead

Study Sites (1)

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

RECRUITING

Related Publications (4)

• Ruiz-Aranda D, Extremera N, Pineda-Galan C. Emotional intelligence, life satisfaction and subjective happiness in female student health professionals: the mediating effect of perceived stress. J Psychiatr Ment Health Nurs. 2014 Mar;21(2):106-13. doi: 10.1111/jpm.12052. Epub 2013 Apr 12.

  PMID: 23578272 BACKGROUND

• Ruiz-Aranda D, Salguero JM, Fernandez-Berrocal P. Emotional intelligence and acute pain: the mediating effect of negative affect. J Pain. 2011 Nov;12(11):1190-6. doi: 10.1016/j.jpain.2011.06.008. Epub 2011 Aug 23.

  PMID: 21865092 BACKGROUND

• Ruiz-Aranda D, Zysberg L, Garcia-Linares E, Castellano-Guerrero AM, Martinez-Brocca MA, Gutierrez-Colosia MR. Emotional abilities and HbA1c levels in patients with type 1 diabetes. Psychoneuroendocrinology. 2018 Jul;93:118-123. doi: 10.1016/j.psyneuen.2018.04.015. Epub 2018 Apr 20.

  PMID: 29723781 RESULT

• Ruiz-Aranda D, Resurreccion DM, Gutierrez-Colosia MR, Martinez-Brocca MA. Intervention in emotional abilities for adolescents with type 1 diabetes mellitus in a hospital setting: a study protocol for a randomised controlled trial. BMJ Open. 2019 Aug 27;9(8):e027913. doi: 10.1136/bmjopen-2018-027913.

  PMID: 31462466 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Officials

• Desireé Ruiz, Psychologist

  Universidad Loyola Andalucía

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Desrieé Ruiz, Psychologist

CONTACT

0034955641600; daruiz@uloyola.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 8, 2018
• Study Start: January 1, 2019
• Primary Completion: May 1, 2019
• Study Completion: December 1, 2021
• Last Updated: November 8, 2018

Record last verified: 2018-11

Locations

ES (1)