Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 23 of 1331 for:    Recruiting, Not yet recruiting, Available Studies | "Depression"

Behavioral Activation Therapy for Medical Students With Symptoms of Depression in Two Cities of Mexico

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04069182
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : August 26, 2019
Sponsor:
Collaborators:
Universidad Autonoma de Ciudad Juarez
Universidad Nacional Autonoma de Mexico
Information provided by (Responsible Party):
Alejandro Dominguez Rodriguez, Universidad Autonoma de Baja California

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.

Condition or disease Intervention/treatment Phase
Depression, Anxiety Behavioral: Behavioral Activation Therapy Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All the patients will be assigned to the treatment.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Behavioral Activation Therapy for Medical Students With Symptoms of Depression in Two Cities of Mexico
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Behavioral Activation Therapy
Psychological intervention
Behavioral: Behavioral Activation Therapy
Behavioral Activation Therapy (BAT) has its origins in Cognitive Behavioral Therapy. In BAT, the patient monitors his emotions and daily activities, as a behavioral element. It seeks to increase the number of pleasant activities and increase interactions with the environment. The BAT considers positive reinforcement as the main intervention strategy. The treatment focuses on helping patients to systematically increase contact with their life's reward sources and solve their problems through procedures that focus on activation and on processes that inhibit it such as escape, avoidance behaviors and ruminant thoughts. It is a brief treatment consisting of 10 to 12 sessions spaced weekly (one hour per session), the first sessions are an explanation of the treatment and depression. Subsequent sessions are based on a collaborative work where the therapist and the patient work together to find activities that are according to the needs of the patient.




Primary Outcome Measures :
  1. Change in the scores of the Center for Epidemiologic Studies Depression (CES-D) scale. [ Time Frame: 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. ]
    Center for Epidemiologic Studies Depression (CES-D) is a structured self-report scale for evaluation depression symptoms. This scale assesses the number of depression symptoms within 2 weeks. The scale consists 20 items and contains 4-point score responses (0 to 3) as the following; rarely or none of the time (less than 1 day); some of a little of the time (1-2 days); occasionally or moderate amount of time (3-4 days) and most or all of the time (5-7 days). The total possible range of scores is from 0 to 60 where ^16 is the cut-off point for this scale, and higher scores indicates more symptoms of depression. It is expected a statistical significant decrease (P < 0.05) in depression symptoms.

  2. Change in the score of Anxiety Symptoms in the Depression Anxiety Stress Scale (DASS-21). [ Time Frame: 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. ]
    The Depression Anxiety Stress Scale-21, is a structured self-report scale that assess the subscales of anxiety, depression and stress symptoms over the past last week. Each subscale contains seven items with responses rated on a 4-point scale (0-3) as follows; 0 Did not apply at me at all; 1 Applied to me to a considerable degree, or some of the time; 2 Applied to me to a considerable degree or a good part of time; 3 Applied to me very much or most of the time. Each subscale has a cut-off point for depression (6), anxiety (5) and stress (6). It is expected a statistical significant decrease (P < 0.05) in depression and anxiety symptoms.

  3. Change in the score of The Pittsburgh Sleep Quality Index. [ Time Frame: 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. ]
    This instrument assesses the quality patterns of sleep. It differentiates the "poor" and "good" sleep by measuring seven areas, where the range score of answers are from 0 to 3, the global sum of this scale can be a value between 0 to 60, and the cutoff point is "5" that indicates a "poor" sleep quality. It is expected a statistical significant increase (P < 0.05) in Sleep Quality test.

  4. Change in the Alpha rhythm measures. [ Time Frame: 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. ]
    Change in the alpha rhythm trough the EEG measure. The increase will be shown comparing the participants in the intervention group within their own results in the pre to post measures.


Secondary Outcome Measures :
  1. Change in the Plutchik Suicide Risk Scale [ Time Frame: 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. ]
    The Plutchik Suicide Risk Scale is a structured self-report questionnaire for evaluating suicide Risk. It consists in 15 items that assess the history of suicide attempts, ideation and suicide plans. It differentiates patients with a suicide risk from the non-suicide risk. This scale has dichotomous responses of Yes/No, and has a cut-off point of 6, where a point above the cut-off means a higher suicide risk. In this study the suicidal patients are not considering for the depression treatment although is necessary assess in depressive patients to referral to specialized treatment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04069182


Contacts
Layout table for location contacts
Contact: Alejandro Dominguez-Rodriguez, PhD +52 1 664 471 32 77 alejandro.dominguez.rodriguez@uabc.edu.mx
Contact: Jasshel Teresa Salinas-Saldivar, MD +52 1 656 3018707 jasshel.salinas@uacj.mx

Locations
Layout table for location information
Mexico
Autonomous University of Baja California Recruiting
Tijuana, Baja California, Mexico, 22427
Contact: Arturo Jimenez-Cruz, PhD    01 (664) 979-75-00    ajimenez@uabc.edu.mx   
Contact: Ana Laura Martínez-Martínez, PhD    01 (664) 682 1233 ext 119    ana.laura.martinez.martinez@uabc.edu.mx   
Autonomous University of Juarez Recruiting
Juarez, Chihuahua, Mexico, 32300
Contact: Flor Rocio Ramirez-Martinez, MD    +5216561238742    rocio.ramirez@uacj.mx   
Contact: Jasshel Teresa Salinas-Saldivar, MD    +5216563018707    jasshel.salinas@uacj.mx   
Sponsors and Collaborators
Universidad Autonoma de Baja California
Universidad Autonoma de Ciudad Juarez
Universidad Nacional Autonoma de Mexico
Investigators
Layout table for investigator information
Study Chair: Paulina Arenas-Landgrave, PhD The National Autonomous University of Mexico
Study Chair: Flor Rocio Ramirez-Martinez, Phd Autonomous University of Juarez
Study Chair: Ahmed Ali Asadi-González, PhD Autonomous University of Baja California
  Study Documents (Full-Text)

Documents provided by Alejandro Dominguez Rodriguez, Universidad Autonoma de Baja California:
Informed Consent Form  [PDF] May 1, 2019


Additional Information:
Publications:
Ruiz Flores, L., Colín Piana, R., Corlay Noriega, I., Lara Muñoz, M., & Dueñas Tentori, H. (2007). Trastorno depresivo mayor en México: la relación entre la intensidad de la depresión, los síntomas físicos dolorosos y la calidad de vida. Salud Mental, 30 (2), 25-32.
Barraca Mairal, J. (2010). Aplicación de la Activación Conductual en un Paciente con Sintomatología Depresiva. Clínica y Salud, 21(2), 183-197.

Layout table for additonal information
Responsible Party: Alejandro Dominguez Rodriguez, Full time professor of Psychology, Universidad Autonoma de Baja California
ClinicalTrials.gov Identifier: NCT04069182     History of Changes
Other Study ID Numbers: 714/2019-1
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The information will be available in a private server or in a server of the journal(s) that we will publish the articles that will be the result of this study. The protocol of the study is currently in progress to be published, in this article will be included such study protocol, the informed consent is already shared in the register of clinical trials.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: This data will be available approximately in june 2020 and it will be permanently available. It wil be shared in the databases of the journal where the article(s) will be published
Access Criteria: Through the servers of the journal(s) where we will publish the articles.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alejandro Dominguez Rodriguez, Universidad Autonoma de Baja California:
Depression
Anxiety
Medicine students
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders