Intervention in Emotional Intelligence in Adolescents With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Change in emotional skills of adolescents with type 1 diabetes related to an increase in healthy life habits
研究概览
简要总结
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.
详细描述
Recent research has indicated that emotional factors have an important role in the control of diabetes. According to previous literature, the burden of diabetes and its treatment contribute to emotional distress. In fact, the emotional discomfort associated with diabetes can influence the control of glycemia as it is related to the decrease of self-care behaviors and adherence to protocols and care routines. The scientific literature shows that high levels of anxiety and depression affect the adherence to treatment of diabetes, since the people who experience it are less likely to comply with health care recommendations due to the difficulty that entails compliance with the imposition of restrictions on their usual lifestyle.
The most widespread definition of emotional intelligence describes it as "the ability to accurately perceive, evaluate and express emotions; the ability to access and / or generate feelings that facilitate thinking; the ability to understand emotions and emotional knowledge; and the ability to regulate emotions promoting emotional and intellectual growth. Research shows that the ability of people to process emotional information adequately is related to effective social functioning, resilience to emotional and social pressures and less emotional impact when faced with certain health problems.
The first preliminary results of a pilot study indicated that adolescents with Type 1 Diabetes Mellitus (DM1) with high emotional abilities have a better glycemic control evaluated through HbA1c and a lower emotional discomfort associated with diabetes. These first data allow us to hypothesize that training in emotional intelligence will facilitate the increase of these skills which will contribute to the improvement of metabolic control (evaluated through HbA1c), healthy lifestyle habits and emotional well-being.
Objectives The first general objective (GO1) of our study is to design a program on emotional intelligence for intervention with adolescents with DM1 aimed at improving therapeutic adherence, healthy lifestyle habits and well-being. The second general objective (GO2) is to analyze the effectiveness of this program of improvement of emotional skills once the program is finished, 6 and 12 months after the intervention.
Pre-intervention phase: The specific objectives (SO) are:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of type 1 Diabetes Mellitus for at least 12 months.
- •Type of treatment, International Unit insulin/kg
排除标准
- •Present some incapacitating psychiatric disorder or other chronic illness.
- •Not giving informed consent
研究组 & 干预措施
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
干预措施: Emotional abilities training program (Behavioral)
Control group
Control group that will not receive the training program on emotional abilities but usual care.
结局指标
主要结局
Change in emotional skills of adolescents with type 1 diabetes related to an increase in healthy life habits
时间窗: 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.
Change in emotional skills of adolescents with type 1 diabetes related to a greater emotional regulation
时间窗: 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.
Change in emotional skills of adolescents with type 1 diabetes related to less stress levels
时间窗: 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
Change in the emotional skills of adolescents with type 1 diabetes that will be related to a glycosylated index between normal values
时间窗: 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.
Change in emotional skills of adolescents with type 1 diabetes related to a greater positive affect
时间窗: 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.
Change in emotional skills of adolescents with type 1 diabetes related to a greater perception of quality of life
时间窗: 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.
次要结局
未报告次要终点
研究者
Desiree Ruiz Aranda
Doctor
Universidad Loyola Andalucia