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

May 5, 2018 updated by: Mariane Bagatin Bermudez

Adaptation of the One-session CBT Protocol for Prevention of Mental Illness for Brazilian Portuguese: Open Clinical Trial

  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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
        • Recruiting
        • Hospital de Clinicas de Porto Alegre
        • Contact:
          • Carolina Blaya, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Medical Students
Cognitive Behavioral Therapy Protocol
Other: Cognitive Behavioral Therapy
One-Session Unified Protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevention of anxiety symptoms
Time Frame: 90 days after
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevention of depression symptoms
Time Frame: 90 days after
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mariane Bagatin Bermudez

Investigators

  • Study Director: Carolina Blaya, Hospital de Clinicas de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Anticipated)

June 30, 2018

Study Completion (Anticipated)

November 30, 2018

Study Registration Dates

First Submitted

December 14, 2017

First Submitted That Met QC Criteria

May 5, 2018

First Posted (Actual)

May 8, 2018

Study Record Updates

Last Update Posted (Actual)

May 8, 2018

Last Update Submitted That Met QC Criteria

May 5, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 73658817.3.1001.5327

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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