NCT03518411

Brief Summary

  1. 1.Recruitment of medicine students of federal university.
  2. 2.Psychiatric interview (MINI) and sclaes application.
  3. 3.Protocol of CBT
  4. 4.Scales and MINI will be applied at the times of 7, 30 and 90 days after the end of the therapy.
  5. 5.Statistical analysis

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 8, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

May 8, 2018

Status Verified

May 1, 2018

Enrollment Period

7 months

First QC Date

December 14, 2017

Last Update Submit

May 5, 2018

Conditions

Mental DisorderCBT

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Prevention of depression symptoms

    90 days after

Study Arms (1)

Medical Students

EXPERIMENTAL

Cognitive Behavioral Therapy Protocol

Other: Cognitive Behavioral Therapy

Interventions

Cognitive Behavioral TherapyOTHER

One-Session Unified Protocol

Medical Students

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • be medical student
  • be over 18 years of age
  • agree to the Term of Free and Informed Consent.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

Related Publications (5)

  • 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.

    PMID: 21437675BACKGROUND

  • 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.

    PMID: 19174678BACKGROUND

  • 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.

    PMID: 26535958BACKGROUND

  • 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.

    PMID: 27923088BACKGROUND

  • 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. 2018 Sep;42(5):781-805. doi: 10.1177/0145445517734354. Epub 2017 Oct 13.

    PMID: 29029563RESULT

MeSH Terms

Conditions

Mental Disorders

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Carolina Blaya

    Hospital de Clínicas de Porto Alegre

    STUDY DIRECTOR

Central Study Contacts

Mariane Bermudez, MD

CONTACT

55 51 999554322bagatinmariane@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 14, 2017

First Posted

May 8, 2018

Study Start

December 1, 2017

Primary Completion

June 30, 2018

Study Completion

November 30, 2018

Last Updated

May 8, 2018

Record last verified: 2018-05

Locations

BR(1)