Depression, AnxietyNCT04069182
Behavioral Activation Therapy for Medical Students With Symptoms of Depression in Two Cities of Mexico
A study testing Behavioral Activation Therapy in people with Depression, Anxiety, run by Universidad Autonoma de Baja California at 2 sites in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Behavioral Activation Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesMexico
- Study dates
- 1 Aug 2019to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Currently studying medicine in one of the institutions of the 2 universities where this study will be conducted.
- Showing symptoms of depression and anxiety.
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Alejandro Dominguez-Rodriguez, PhD contact
Mexico2 sites, 2 recruiting
- Recruiting
Autonomous University of Juarez
Juárez, Chihuahua, 32300
Flor Rocio Ramirez-Martinez, MD, +5216561238742, rocio.ramirez@uacj.mx
Jasshel Teresa Salinas-Saldivar, MD, +5216563018707, jasshel.salinas@uacj.mx
- Recruiting
Autonomous University of Baja California
Tijuana, Estado de Baja California, 22427
Arturo Jimenez-Cruz, PhD, 01 (664) 979-75-00, ajimenez@uabc.edu.mx
Ana Laura Martínez-Martínez, PhD, 01 (664) 682 1233 ext. 119, ana.laura.martinez.martinez@uabc.edu.mx
About this study
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.
Read the 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.
- Conditions
- Depression, Anxiety
- Being tested
- Behavioral Activation Therapy
- Keywords
- Depression, Anxiety, Medicine students
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Activation TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Activation Therapy | Other | Psychological intervention Receives: Behavioral: Behavioral Activation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Aug 2019
- Primary completionJun 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All the patients will be assigned to the treatment.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Baja California
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Autonoma de Ciudad Juarez, Universidad Nacional Autonoma de Mexico
- Responsible party
- Principal investigator, Alejandro Dominguez Rodriguez, Universidad Autonoma de Baja California
- Investigators
- Paulina Arenas-Landgrave, PhD, Study chair, The National Autonomous University of MexicoFlor Rocio Ramirez-Martinez, Phd, Study chair, Autonomous University of JuarezAhmed Ali Asadi-González, PhD, Study chair, Autonomous University of Baja California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069182
- Sponsor's protocol ID
- 714/2019-1
- Status last verified
- Aug 2019
- First submitted
- 22 Aug 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
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.
PubMed 30333763Pacheco 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.
PubMed 28876408Stack S. Suicide risk among physicians: a multivariate analysis. Arch Suicide Res. 2004;8(3):287-92. doi: 10.1080/13811110490436954.
PubMed 16081394Jadoon 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.
PubMed 20726214Cuijpers 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.
PubMed 17184887Barraca Mairal, J. (2010). Aplicación de la Activación Conductual en un Paciente con Sintomatología Depresiva. Clínica y Salud, 21(2), 183-197.
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.
PubMed 23469262Norton 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.
PubMed 17999228Buysse 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.
PubMed 2748771Koslowsky 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.
PubMed 1779413Goldman 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.
PubMed 12499854
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Activation Therapy for Medical Students With Symptoms of Depression in Two Cities of Mexico
- ClinicalTrials.gov ID
- NCT04069182
- Acronym / sponsor ID
- 714/2019-1
- Conditions
- Depression, Anxiety
- Keywords
- Depression, Anxiety, Medicine students
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidad Autonoma de Baja CaliforniaUniversity, hospital or other
- Collaborators
- Universidad Autonoma de Ciudad Juarez, Universidad Nacional Autonoma de Mexico
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All the patients will be assigned to the treatment.
| Arm | Type | Receives |
|---|---|---|
| Behavioral Activation Therapy | Other | Behavioral: Behavioral Activation TherapyPsychological intervention |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Currently studying medicine in one of the institutions of the 2 universities where this study will be conducted.
- Showing symptoms of depression and anxiety.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Activation TherapyBehavioral 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. | Behavioural | Behavioral Activation Therapy |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- BackgroundRuiz 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: PubMed 30333763Tolentino 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.
- Background: PubMed 28876408Pacheco 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.
- Background: PubMed 16081394Stack S. Suicide risk among physicians: a multivariate analysis. Arch Suicide Res. 2004;8(3):287-92. doi: 10.1080/13811110490436954.
- Background: PubMed 20726214Jadoon 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.
- Background: PubMed 17184887Cuijpers 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.
- BackgroundBarraca Mairal, J. (2010). Aplicación de la Activación Conductual en un Paciente con Sintomatología Depresiva. Clínica y Salud, 21(2), 183-197.
- Background: PubMed 23469262Carleton 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.
- Background: PubMed 17999228Norton 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.
- Background: PubMed 2748771Buysse 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.
- Background: PubMed 1779413Koslowsky 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.
- Background: PubMed 12499854Goldman 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.
- Mexico \| Institute for Health Metrics and EvaluationLink provided by the sponsor.
- Physician SuicideLink provided by the sponsor.
- Estadística a propósito del día mundial para la prevención del suicidio (Statistics regarding the World Day for the Prevention of Suicide)Link provided by the sponsor.
- EMOTIV EPOCLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandro Dominguez-Rodriguez, PhD contact
Paulina Arenas-Landgrave, PhD study chair
The National Autonomous University of Mexico
Flor Rocio Ramirez-Martinez, Phd study chair
Autonomous University of Juarez
Ahmed Ali Asadi-González, PhD study chair
Autonomous University of Baja California
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation Therapy in people with Depression, Anxiety, run by Universidad Autonoma de Baja California at 2 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alejandro Dominguez-Rodriguez, PhD (+52 1 664 471 32 77, alejandro.dominguez.rodriguez@uabc.edu.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04069182, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.