Clinical trial NCT04069182: Behavioral Activation Therapy for Medical Students With Symptoms of Depression in Two Cities of Mexico
Official title: Behavioral Activation Therapy for Medical Students With Symptoms of Depression in Two Cities of Mexico
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression, Anxiety
Keywords: Depression
Anxiety
Medicine students
Lead sponsor: Universidad Autonoma de Baja California
Sponsor class: OTHER
Collaborators: name: Universidad Autonoma de Ciudad Juarez
name: Universidad Nacional Autonoma de Mexico
First posted: 2019-08-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All the patients will be assigned to the treatment.
Primary purpose: TREATMENT

Brief summary: This study evaluates the effectiveness of The Behavioral Activation Protocol, a psychological treatment for the intervention of mild to moderate depression. It is compared the effectiveness of the treatment with the changes of the same participants before and after the treatment. The changes are being assessed through subjective measures such as psychometrics and objective measures such as electroencephalography.

Detailed description: Depression is currently one of the mental health disorders that have gained relevance globally due to its constant increase in recent years. In Mexico, it is the disease that occupies the fourth position of diseases that cause disability. This disorder manifests as symptoms of physical pain when it is at high levels, resulting in a decrease in the quality of life. Other symptoms are; changes in eating, sleeping habits, and also presents comorbidity with anxiety disorders. In some cases, is presented suicidal ideation and behavior.

University students belong to the vulnerable age group, among them it has been shown that it is medical students who have symptoms of depression and are 2.45 times more likely to commit suicide compared to the general population. Medical students are a population at risk taking the characteristics of mental disorders such as depression, which can lead to abandoning studies, makes it difficult to work efficiently, and is present the deterioration of social relationships.

In the statistics on the death of doctors, between 300 and 400 doctors commit suicide each year in the United States alone (2018). In contrast, in Mexico there is no reported suicide statistics in doctors, however the data shows that the phenomenon of suicide has increased in recent years in the general population.

The patients will be treated through Behavioral Activation Therapy. Through some studies, the efficacy of the Behavioral Activation Therapy has been confirmed compared to exclusively cognitive cutting therapy. Other studies have corroborated the effectiveness of Behavioral Activation Therapy through a meta-analysis comparing this model with waiting list groups, placebo, conventional treatment and has even obtained better results with drugs treating cases of severe depression.

This study will have only one intervention group, without a control group or waiting list. The patients will be submitted to pre and post treatment. The subjective measures will be:

1. -The Center for Epidemiologic Studies - Depression (CES-D) scale.
2. - The Depression, Anxiety and Stress Scale - 21 Items (DASS-21).
3. - Pittsburgh Sleep Quality Index.
4. - The Plutchik Suicide Risk Scale

Also it is planned to measure the brain activity of the patients through an electroencephalogram, specifically the alpha and beta rhythms. To perform this measure, it will be used the EMOTIVE EPOC + of 14 channels is non-invasive, painless, low cost method Used for scientific research. The 14 channels with which the device counts. It allows to measure the cerebral areas AF3, F7, F3, FC5, T7, P7, O1, O2, P8, T8, FC6, F4, F8, AF4, based on the international system 10-20.

The intervention will be implemented in two cities in two public universities. Autonomous University of Baja California at the Faculty of Medicine and Psychology and the Autonomous University of Juarez at the Institute of Biomedical Sciences.

Eligibility criteria: Inclusion Criteria:

* Currently studying medicine in one of the institutions of the 2 universities where this study will be conducted.
* Showing symptoms of depression and anxiety.

Exclusion Criteria:

* Consuming drugs
* To receive another psychological treatment in the same period of the study
* To show comorbidity with a psychiatric disorder
* Moderate to high score in the suicide scale
* Recent attempt of suicide (3 months)

Primary outcomes:
measure: Change in the scores of the Center for Epidemiologic Studies Depression (CES-D) scale.
timeFrame: 2.5 to 3 months, depending on the development of the patient and the sessions needed, ranging from 10 to 12 sessions needed, once per week.
measure: Change in the score of Anxiety Symptoms in the Depression Anxiety Stress Scale (DASS-21).
timeFrame: 2.5 to 3 months, depending on the development of the patient and the sessions needed, ranging from 10 to 12 sessions needed, once per week.
measure: Change in the score of The Pittsburgh Sleep Quality Index.
timeFrame: 2.5 to 3 months, depending on the development of the patient and the sessions needed, ranging from 10 to 12 sessions needed, once per week.
measure: Change in the Alpha rhythm measures.
timeFrame: 2.5 to 3 months, depending on the development of the patient and the sessions needed, ranging from 10 to 12 sessions needed, once per week.
Secondary outcomes:
measure: Change in the Plutchik Suicide Risk Scale
timeFrame: 2.5 to 3 months, depending on the development of the patient and the sessions needed, ranging from 10 to 12 sessions needed, once per week.
Other outcomes:
Locations:
city: Tijuana
country: Mexico
facility: Autonomous University of Baja California
state: Baja California
city: Juarez
country: Mexico
facility: Autonomous University of Juarez
state: Chihuahua
Study officials:
affiliation: The National Autonomous University of Mexico
name: Paulina Arenas-Landgrave, PhD
role: STUDY_CHAIR
affiliation: Autonomous University of Juarez
name: Flor Rocio Ramirez-Martinez, Phd
role: STUDY_CHAIR
affiliation: Autonomous University of Baja California
name: Ahmed Ali Asadi-González, PhD
role: STUDY_CHAIR
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