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Adaptation of the One-session CBT Protocol for Prevention of Mental Illness for Brazilian Portuguese (UP)

Primary Purpose

Mental Disorder, CBT

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Sponsored by
Mariane Bagatin Bermudez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mental Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hospital de Clínicas de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Medical Students

Arm Description

Cognitive Behavioral Therapy Protocol

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 14, 2017
Last Updated
May 5, 2018
Sponsor
Mariane Bagatin Bermudez
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1. Study Identification

Unique Protocol Identification Number
NCT03518411
Brief Title
Adaptation of the One-session CBT Protocol for Prevention of Mental Illness for Brazilian Portuguese
Acronym
UP
Official Title
Adaptation of the One-session CBT Protocol for Prevention of Mental Illness for Brazilian Portuguese: Open Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
June 30, 2018 (Anticipated)
Study Completion Date
November 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mariane Bagatin Bermudez

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorder, CBT

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Medical Students
Arm Type
Experimental
Arm Description
Cognitive Behavioral Therapy Protocol
Intervention Type
Other
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
One-Session Unified Protocol
Primary Outcome Measure Information:
Title
Prevention of anxiety symptoms
Description
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.
Time Frame
90 days after
Secondary Outcome Measure Information:
Title
Prevention of depression symptoms
Description
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.
Time Frame
90 days after

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mariane Bermudez, MD
Phone
55 51 999554322
Email
bagatinmariane@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolina Blaya
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Study Director
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolina Blaya, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21437675
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.
Results Reference
background
PubMed Identifier
19174678
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.
Results Reference
background
PubMed Identifier
26535958
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.
Results Reference
background
PubMed Identifier
27923088
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.
Results Reference
background
PubMed Identifier
29029563
Citation
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.
Results Reference
result

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Adaptation of the One-session CBT Protocol for Prevention of Mental Illness for Brazilian Portuguese

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