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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03518411
Other study ID # 73658817.3.1001.5327
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2017
Est. completion date November 30, 2018

Study information

Verified date May 2018
Source Hospital de Clinicas de Porto Alegre
Contact Mariane Bermudez, MD
Phone 55 51 999554322
Email bagatinmariane@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

1. Recruitment of medicine students of federal university.

2. Psychiatric interview (MINI) and sclaes application.

3. Protocol of CBT

4. Scales and MINI will be applied at the times of 7, 30 and 90 days after the end of the therapy.

5. Statistical analysis


Recruitment information / eligibility

Status Recruiting
Enrollment 62
Est. completion date November 30, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- be medical student

- be over 18 years of age

- agree to the Term of Free and Informed Consent.

Exclusion Criteria:

- Students with psychotic illness, severe depression, manic episode or acute psychiatric risk.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Cognitive Behavioral Therapy
One-Session Unified Protocol

Locations

Country Name City State
Brazil Hospital de Clínicas de Porto Alegre Porto Alegre Rio Grande Do Sul

Sponsors (1)

Lead Sponsor Collaborator
Mariane Bagatin Bermudez

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

Bentley KH, Boettcher H, Bullis JR, Carl JR, Conklin LR, Sauer-Zavala S, Pierre-Louis C, Farchione TJ, Barlow DH. Development of a Single-Session, Transdiagnostic Preventive Intervention for Young Adults at Risk for Emotional Disorders. Behav Modif. 2017 — View Citation

Fisak BJ Jr, Richard D, Mann A. The prevention of child and adolescent anxiety: a meta-analytic review. Prev Sci. 2011 Sep;12(3):255-68. doi: 10.1007/s11121-011-0210-0. Review. — View Citation

Goebert D, Thompson D, Takeshita J, Beach C, Bryson P, Ephgrave K, Kent A, Kunkel M, Schechter J, Tate J. Depressive symptoms in medical students and residents: a multischool study. Acad Med. 2009 Feb;84(2):236-41. doi: 10.1097/ACM.0b013e31819391bb. — View Citation

Guille C, Zhao Z, Krystal J, Nichols B, Brady K, Sen S. Web-Based Cognitive Behavioral Therapy Intervention for the Prevention of Suicidal Ideation in Medical Interns: A Randomized Clinical Trial. JAMA Psychiatry. 2015 Dec;72(12):1192-8. doi: 10.1001/jamapsychiatry.2015.1880. — View Citation

Rotenstein LS, Ramos MA, Torre M, Segal JB, Peluso MJ, Guille C, Sen S, Mata DA. Prevalence of Depression, Depressive Symptoms, and Suicidal Ideation Among Medical Students: A Systematic Review and Meta-Analysis. JAMA. 2016 Dec 6;316(21):2214-2236. doi: 10.1001/jama.2016.17324. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Prevention of anxiety symptoms Overall Anxiety Severity and Impairment Scale (OASIS). It is a 5-item self-report measure that can be used to assess severity and impairment associated with any anxiety disorder. Respondents select among five different response options for each item, which are coded 0-4 and summed to obtain a total score. A cut-score of 8 correctly classified 87% of this sample as having an anxiety diagnosis or not. 90 days after
Secondary Prevention of depression symptoms Beck Depression Inventory (BDI). It is a 21-question multiple-choice self-report inventory for measuring the severity of depression. Each question had a set of at least four possible (0 to 3) responses, ranging in intensity. Scores: 0-9: indicates minimal depression, 10-18: indicates mild depression, 19-29: indicates moderate depression, 30-63: indicates severe depression. 90 days after
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