Clinical trial NCT02889172: Intervention for Reducing Psychiatric Symptoms and Metabolic Variables in Patients With Diabetes Mellitus (DM)
Official title: Brief Intervention for Reducing Depressive and Anxiety Symptoms and Their Impact on Metabolic Variables in Patients With Type II Diabetes Mellitus and Obesity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
Sponsor class: OTHER
Collaborators: name: Universidad Nacional Autonoma de Mexico
First posted: 2016-09-05
Enrollment: 70
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Second Stage: Application of brief intervention (PST) in patients with diagnosis of Diabetes and Obesity.

Stage Three: Analysis of results and publication of the study. Study design. A randomized, longitudinal, comparative clinical trial will be used.

Patients:

The study population will be 70 patients (35 experimental and 35 controls) of 11 primary care centers in Mexico City, with diagnosis of type II diabetes mellitus and / or obesity.

Inclusion criteria

1. 35-70 years old
2. Female and male
3. Type II Diabetes Mellitus
4. Obesity (BMI ≥ 30)
5. K-10 ≥ 21 points
6. Beck Depression Inventory 13 to ≤ 28 points
7. Beck Anxiety Inventory 7 to ≤ 25 points
8. Informed consent accepted and signed

Exclusion criteria

1. Severe depression or suicidal ideation
2. Type I Diabetes Mellitus

Procedure. Patients with K-10 ≥ 21 will invited to participate in the project; sign the informed consent and complete the Depression and Anxiety Beck Inventory; randomly, each subject will be assigned to the experimental or control group. Patients in the experimental group will receive the PST while the control group will receive usual treatment.

Metabolic variables: Glucose, weight, blood pressure, body mass index, total cholesterol, triglycerides and waist circumference at baseline, at 6 weeks and 4 months will be evaluated during the study.

Statistical Analysis. Percentages, means, standard deviation, Chi square, t student for independent samples and analysis of variance for repeated measures will be used.

Eligibility criteria: Inclusion Criteria:

1. 35-70 years old
2. Female and male
3. Type II Diabetes Mellitus
4. Obesity (BMI ≥ 30)
5. K-10 ≥ 21 points
6. Beck Depression Inventory 13 to ≤ 28 points
7. Beck Anxiety Inventory 7 to ≤ 25 points
8. Informed consent accepted and signed

Exclusion Criteria:

1. Severe depression or suicidal ideation
2. Type I Diabetes Mellitus

Elimination criteria

1. Questionnaires and scales incomplete
2. Two sessions of PST missing
3. Exacerbation of depressive and / or anxious symptoms during the intervention or monitoring

Primary outcomes:
measure: Beck Depression Inventory
timeFrame: Six months
Secondary outcomes:
measure: Beck Anxiety Inventory
timeFrame: Six Months
measure: Simplified Medication Adherence Questionnaire
timeFrame: Six Months
Other outcomes:
Locations:
city: Mexico city
country: Mexico
facility: Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
Study officials:
References: