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

NCT04069182 | Unknown DMC

• 1 other identifier: 714/2019-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Depression, Anxiety

Keywords

Depression; Anxiety; Medicine students

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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.

• 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 Outcomes (1)

• Change in the Plutchik Suicide Risk Scale

  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.

Study Arms (1)

Behavioral Activation Therapy

OTHER

Psychological intervention

Behavioral: Behavioral Activation Therapy

Interventions

Behavioral Activation Therapy 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.

Behavioral Activation Therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universidad Autonoma de Baja California: lead
• Universidad Autonoma de Ciudad Juarez: collaborator
• Universidad Nacional Autonoma de Mexico: collaborator

Study Sites (2)

Autonomous University of Juarez

Juárez, Chihuahua, 32300, Mexico

RECRUITING

Autonomous University of Baja California

Tijuana, Estado de Baja California, 22427, Mexico

RECRUITING

Related Publications (12)

• 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.

  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.

  PMID: 30333763 BACKGROUND

• 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.

  PMID: 28876408 BACKGROUND

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

  PMID: 16081394 BACKGROUND

• 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.

  PMID: 20726214 BACKGROUND

• 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.

  PMID: 17184887 BACKGROUND

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

  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.

  PMID: 23469262 BACKGROUND

• 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.

  PMID: 17999228 BACKGROUND

• 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.

  PMID: 2748771 BACKGROUND

• 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.

  PMID: 1779413 BACKGROUND

• 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.

  PMID: 12499854 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• 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 CHAIR

Central Study Contacts

Alejandro Dominguez-Rodriguez, PhD

CONTACT

+52 1 664 471 32 77; alejandro.dominguez.rodriguez@uabc.edu.mx

Jasshel Teresa Salinas-Saldivar, MD

CONTACT

+52 1 656 3018707; jasshel.salinas@uacj.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full time professor of Psychology

Model Details: All the patients will be assigned to the treatment.

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 28, 2019
• Study Start: August 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: July 1, 2020
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

ME (2)