Behavioral Activation Therapy for Medical Students With Symptoms of Depression in Two Cities of Mexico
Primary Purpose
Depression, Anxiety
Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Behavioral Activation Therapy
Sponsored by

About this trial
This is an interventional treatment trial for Depression, Anxiety focused on measuring Depression, Anxiety, Medicine students
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)
Sites / Locations
- Autonomous University of Baja CaliforniaRecruiting
- Autonomous University of JuarezRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Behavioral Activation Therapy
Arm Description
Psychological intervention
Outcomes
Primary Outcome Measures
Change in the scores of the Center for Epidemiologic Studies Depression (CES-D) scale.
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.
Change in the score of Anxiety Symptoms in the Depression Anxiety Stress Scale (DASS-21).
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.
Change in the score of The Pittsburgh Sleep Quality Index.
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.
Change in the Alpha rhythm measures.
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
Change in the Plutchik Suicide Risk Scale
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.
Full Information
NCT ID
NCT04069182
First Posted
August 22, 2019
Last Updated
August 23, 2019
Sponsor
Universidad Autonoma de Baja California
Collaborators
Universidad Autonoma de Ciudad Juarez, Universidad Nacional Autonoma de Mexico
1. Study Identification
Unique Protocol Identification Number
NCT04069182
Brief Title
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
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Autonoma de Baja California
Collaborators
Universidad Autonoma de Ciudad Juarez, Universidad Nacional Autonoma de Mexico
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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:
-The Center for Epidemiologic Studies - Depression (CES-D) scale.
- The Depression, Anxiety and Stress Scale - 21 Items (DASS-21).
- Pittsburgh Sleep Quality Index.
- 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
Keywords
Depression, Anxiety, Medicine students
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All the patients will be assigned to the treatment.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Behavioral Activation Therapy
Arm Type
Other
Arm Description
Psychological intervention
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Activation Therapy
Intervention Description
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 Measure Information:
Title
Change in the scores of the Center for Epidemiologic Studies Depression (CES-D) scale.
Description
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.
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.
Title
Change in the score of Anxiety Symptoms in the Depression Anxiety Stress Scale (DASS-21).
Description
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.
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.
Title
Change in the score of The Pittsburgh Sleep Quality Index.
Description
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.
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.
Title
Change in the Alpha rhythm measures.
Description
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.
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.
Secondary Outcome Measure Information:
Title
Change in the Plutchik Suicide Risk Scale
Description
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.
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alejandro Dominguez-Rodriguez, PhD
Phone
+52 1 664 471 32 77
Email
alejandro.dominguez.rodriguez@uabc.edu.mx
First Name & Middle Initial & Last Name or Official Title & Degree
Jasshel Teresa Salinas-Saldivar, MD
Phone
+52 1 656 3018707
Email
jasshel.salinas@uacj.mx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulina Arenas-Landgrave, PhD
Organizational Affiliation
The National Autonomous University of Mexico
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Flor Rocio Ramirez-Martinez, Phd
Organizational Affiliation
Autonomous University of Juarez
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ahmed Ali Asadi-González, PhD
Organizational Affiliation
Autonomous University of Baja California
Official's Role
Study Chair
Facility Information:
Facility Name
Autonomous University of Baja California
City
Tijuana
State/Province
Baja California
ZIP/Postal Code
22427
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arturo Jimenez-Cruz, PhD
Phone
01 (664) 979-75-00
Email
ajimenez@uabc.edu.mx
First Name & Middle Initial & Last Name & Degree
Ana Laura Martínez-Martínez, PhD
Phone
01 (664) 682 1233
Ext
119
Email
ana.laura.martinez.martinez@uabc.edu.mx
Facility Name
Autonomous University of Juarez
City
Juarez
State/Province
Chihuahua
ZIP/Postal Code
32300
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flor Rocio Ramirez-Martinez, MD
Phone
+5216561238742
Email
rocio.ramirez@uacj.mx
First Name & Middle Initial & Last Name & Degree
Jasshel Teresa Salinas-Saldivar, MD
Phone
+5216563018707
Email
jasshel.salinas@uacj.mx
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing 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
IPD Sharing Access Criteria
Through the servers of the journal(s) where we will publish the articles.
Citations:
Citation
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.
Results Reference
background
PubMed Identifier
30333763
Citation
Tolentino JC, Schmidt SL. DSM-5 Criteria and Depression Severity: Implications for Clinical Practice. Front Psychiatry. 2018 Oct 2;9:450. doi: 10.3389/fpsyt.2018.00450. eCollection 2018.
Results Reference
background
PubMed Identifier
28876408
Citation
Pacheco JP, Giacomin HT, Tam WW, Ribeiro TB, Arab C, Bezerra IM, Pinasco GC. Mental health problems among medical students in Brazil: a systematic review and meta-analysis. Braz J Psychiatry. 2017 Oct-Dec;39(4):369-378. doi: 10.1590/1516-4446-2017-2223. Epub 2017 Aug 31.
Results Reference
background
PubMed Identifier
16081394
Citation
Stack S. Suicide risk among physicians: a multivariate analysis. Arch Suicide Res. 2004;8(3):287-92. doi: 10.1080/13811110490436954.
Results Reference
background
PubMed Identifier
20726214
Citation
Jadoon NA, Yaqoob R, Raza A, Shehzad MA, Zeshan SC. Anxiety and depression among medical students: a cross-sectional study. J Pak Med Assoc. 2010 Aug;60(8):699-702.
Results Reference
background
PubMed Identifier
17184887
Citation
Cuijpers P, van Straten A, Warmerdam L. Behavioral activation treatments of depression: a meta-analysis. Clin Psychol Rev. 2007 Apr;27(3):318-26. doi: 10.1016/j.cpr.2006.11.001. Epub 2006 Dec 19.
Results Reference
background
Citation
Barraca Mairal, J. (2010). Aplicación de la Activación Conductual en un Paciente con Sintomatología Depresiva. Clínica y Salud, 21(2), 183-197.
Results Reference
background
PubMed Identifier
23469262
Citation
Carleton RN, Thibodeau MA, Teale MJ, Welch PG, Abrams MP, Robinson T, Asmundson GJ. The center for epidemiologic studies depression scale: a review with a theoretical and empirical examination of item content and factor structure. PLoS One. 2013;8(3):e58067. doi: 10.1371/journal.pone.0058067. Epub 2013 Mar 1.
Results Reference
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PubMed Identifier
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Citation
Norton PJ. Depression Anxiety and Stress Scales (DASS-21): psychometric analysis across four racial groups. Anxiety Stress Coping. 2007 Sep;20(3):253-65. doi: 10.1080/10615800701309279.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
1779413
Citation
Koslowsky M, Bleich A, Greenspoon A, Wagner B, Apter A, Solomon Z. Assessing the validity of the Plutchik Suicide Risk Scale. J Psychiatr Res. 1991;25(4):155-8. doi: 10.1016/0022-3956(91)90019-7.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
background
Links:
URL
http://www.healthdata.org/mexico
Description
Mexico | Institute for Health Metrics and Evaluation
URL
https://emedicine.medscape.com/article/806779-overview
Description
Physician Suicide
URL
https://www.inegi.org.mx
Description
Estadística a propósito del día mundial para la prevención del suicidio (Statistics regarding the World Day for the Prevention of Suicide)
URL
https://www.emotiv.com/epoc/
Description
EMOTIV EPOC
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Behavioral Activation Therapy for Medical Students With Symptoms of Depression in Two Cities of Mexico
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