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临床试验/NCT02889172
NCT02889172终止不适用

Brief Intervention for Reducing Depressive and Anxiety Symptoms and Their Impact on Metabolic Variables in Patients With Type II Diabetes Mellitus and Obesity

Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2015年2月1日最近更新:
适应症

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

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

发起方
Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
申办方类型
Other
责任方
Principal Investigator
主要研究者

Valerio Villamil-Salcedo

PhD

Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente

研究点 (2)

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