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

NCT ID: NCT04069182

Last Updated: 2019-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2020-07-31

Brief Summary

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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

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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.

Conditions

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Depression, Anxiety

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All the patients will be assigned to the treatment.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Behavioral Activation Therapy

Psychological intervention

Group Type OTHER

Behavioral Activation Therapy

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Autonoma de Ciudad Juarez

OTHER

Sponsor Role collaborator

Universidad Nacional Autonoma de Mexico

OTHER

Sponsor Role collaborator

Universidad Autonoma de Baja California

OTHER

Sponsor Role lead

Responsible Party

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Alejandro Dominguez Rodriguez

Full time professor of Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Paulina Arenas-Landgrave, PhD

Role: STUDY_CHAIR

The National Autonomous University of Mexico

Flor Rocio Ramirez-Martinez, Phd

Role: STUDY_CHAIR

Autonomous University of Juarez

Ahmed Ali Asadi-González, PhD

Role: STUDY_CHAIR

Autonomous University of Baja California

Locations

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Autonomous University of Juarez

Juárez, Chihuahua, Mexico

Site Status RECRUITING

Autonomous University of Baja California

Tijuana, Estado de Baja California, Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Alejandro Dominguez-Rodriguez, PhD

Role: CONTACT

+52 1 664 471 32 77

Jasshel Teresa Salinas-Saldivar, MD

Role: CONTACT

+52 1 656 3018707

Facility Contacts

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Flor Rocio Ramirez-Martinez, MD

Role: primary

+5216561238742

Jasshel Teresa Salinas-Saldivar, MD

Role: backup

+5216563018707

Arturo Jimenez-Cruz, PhD

Role: primary

01 (664) 979-75-00

Ana Laura Martínez-Martínez, PhD

Role: backup

01 (664) 682 1233 ext. 119

References

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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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 30333763 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28876408 (View on PubMed)

Stack S. Suicide risk among physicians: a multivariate analysis. Arch Suicide Res. 2004;8(3):287-92. doi: 10.1080/13811110490436954.

Reference Type BACKGROUND
PMID: 16081394 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20726214 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17184887 (View on PubMed)

Barraca Mairal, J. (2010). Aplicación de la Activación Conductual en un Paciente con Sintomatología Depresiva. Clínica y Salud, 21(2), 183-197.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 23469262 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17999228 (View on PubMed)

Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

Reference Type BACKGROUND
PMID: 2748771 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1779413 (View on PubMed)

Goldman RI, Stern JM, Engel J Jr, Cohen MS. Simultaneous EEG and fMRI of the alpha rhythm. Neuroreport. 2002 Dec 20;13(18):2487-92. doi: 10.1097/01.wnr.0000047685.08940.d0.

Reference Type BACKGROUND
PMID: 12499854 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Related Links

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http://www.healthdata.org/mexico

Mexico \| Institute for Health Metrics and Evaluation

https://www.inegi.org.mx

Estadística a propósito del día mundial para la prevención del suicidio (Statistics regarding the World Day for the Prevention of Suicide)

Other Identifiers

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714/2019-1

Identifier Type: -

Identifier Source: org_study_id

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