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

Depression, Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04069182
• Other study ID #: 714/2019-1
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: July 2020

Study information

• Verified date: August 2019
• Source: Universidad Autonoma de Baja California
• Contact: Alejandro Dominguez-Rodriguez, PhD
• Phone: +52 1 664 471 32 77
• Email: alejandro.dominguez.rodriguez[@]uabc.edu.mx
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Depression, Anxiety
• Depressive Disorder

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.

Locations

Country	Name	City	State
Mexico	Autonomous University of Juarez	Juarez	Chihuahua
Mexico	Autonomous University of Baja California	Tijuana	Baja California

Sponsors (3)

Lead Sponsor	Collaborator
Universidad Autonoma de Baja California	Universidad Autonoma de Ciudad Juarez, Universidad Nacional Autonoma de Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (12)

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

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. — View 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. Review. — View 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. Epub 2006 Dec 19. — View Citation

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. — View 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. — View 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. — View 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. — View 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. Review. — View 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.

Stack S. Suicide risk among physicians: a multivariate analysis. Arch Suicide Res. 2004;8(3):287-92. — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.
Primary	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.	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.
Primary	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.	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.
Primary	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.	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	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.	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.

External Links

•   Depression and Other Common Mental Disorders Global Health Estimates
•   EMOTIV EPOC
•   Estadística a propósito del día mundial para la prevención del suicidio (Statistics regarding the World Day for the Prevention of Suicide)
•   Mexico | Institute for Health Metrics and Evaluation
•   Physician Suicide