Brief Intervention for Reducing Depressive and Anxiety Symptoms and Their Impact on Metabolic Variables in Patients With Type II Diabetes Mellitus and Obesity
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Beck Depression Inventory
研究概览
简要总结
The purpose of this study is apply a Brief Intervention (PST) in Diabetic and Obesity patient in primary care of Mexico City to improve their depressive and anxious symptoms and stabilization of metabolic variables.
详细描述
Diabetes and depression are chronic diseases that affect the quality of life of people and they increase disability and reduced life expectancy. The World Health Organization estimates there will be 300 million people with diabetes worldwide. The International Diabetes Federation warns that there are currently 382 million diabetics and may increase to 471 million in 2035 if it fails to make an international preventive action.
Furthermore, depression and anxiety disorders are the most common mental disorders worldwide. It is estimated that in 2030, depression will be the principal cause of all diseases worldwide; while anxiety disorders are related to other mental and medical conditions that prolong disability.
For these reasons, researchers have developed brief psychotherapeutic treatments with good results (Cognitive and Behavioural Therapy, Interpersonal therapy, and others) but with limitations due to lack of trained personnel for such interventions. However, the need for the care of people with diabetes with depression and anxiety symptoms are increasing, and pharmacological and therapeutic treatments are not enough. In other countries are using the Problem Solving Therapy (PST) as a brief technique to support the patient for possible solutions for daily problems which will generate emotional distress and depressive and anxiety symptoms. PST focuses on learning to cope with specific problems areas and where therapist and patient work collaboratively to identify and prioritise key problem areas, to break problems down into specific, manageable tasks, problem solve, and develop appropriate coping behaviours for problems. World Health Organization recommends the PST for depression treatment, which act "in the here and now" that helps identify a relationship between physical and emotional symptoms. Previous studies have shown the efficacy of the PST in reducing depressive and anxiety symptoms. The therapist may be a general practitioner, nurse, psychologist, social worker, etc., which serves as "advisor or counselor" while the patient is an active entity to solve their problems.
Objective The aim of this study is apply a Brief Intervention (PST) in Diabetic and Obesity patients in primary care centers of Mexico City to improve their depressive and anxious symptoms and assess their impact on treatment and stabilization of metabolic variables.
Method First Stage: Training medical students who are in last part of their education of medicine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 35 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •35-70 years old
- •Female and male
- •Type II Diabetes Mellitus
- •Obesity (BMI ≥ 30)
- •K-10 ≥ 21 points
- •Beck Depression Inventory 13 to ≤ 28 points
- •Beck Anxiety Inventory 7 to ≤ 25 points
- •Informed consent accepted and signed
排除标准
- •Severe depression or suicidal ideation
- •Type I Diabetes Mellitus
- •Elimination criteria
- •Questionnaires and scales incomplete
- •Two sessions of PST missing
- •Exacerbation of depressive and / or anxious symptoms during the intervention or monitoring
结局指标
主要结局
Beck Depression Inventory
时间窗: Six months
The Beck Depression Inventory is a questionnaire of 21 items , is a self- applied instrument ; and determines the severity of depression in a Likert scale ranging from 0 to 4 points ; the minimum score is 0 and the maximum of 63 points : 0-13 = minimal depression ; 14-19 = mild depression ; 20-28 = moderate depression ; 29-63 = severe depression . This instrument has been used in several international studies and in Mexico showing validity and reliability.
次要结局
- Simplified Medication Adherence Questionnaire(Six Months)
- Beck Anxiety Inventory(Six Months)
研究者
Valerio Villamil-Salcedo
PhD
Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
