Mental DisorderUPNCT03518411
Adaptation of the One-session CBT Protocol for Prevention of Mental Illness for Brazilian Portuguese
A study testing Cognitive Behavioral Therapy in people with Mental Disorder and CBT, run by Mariane Bagatin Bermudez at 1 site in Brazil.
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Disorder, CBT
- What is being tested?
- Cognitive Behavioral Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Dec 2017to 30 Nov 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- be medical student
- be over 18 years of age
- agree to the Term of Free and Informed Consent.
Who cannot join
- Students with psychotic illness, severe depression, manic episode or acute psychiatric risk.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Carolina Blaya, PhD
About this study
Official title: Adaptation of the One-session CBT Protocol for Prevention of Mental Illness for Brazilian Portuguese: Open Clinical Trial
- 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
- Conditions
- Mental Disorder, CBT
- Being tested
- Cognitive Behavioral Therapy
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyOther
One-Session Unified Protocol
| Study group | Role | What they receive |
|---|---|---|
| Medical Students | Experimental | Cognitive Behavioral Therapy Protocol Receives: Other: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days after
Secondary outcomes (1)
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.
Measured: 90 days after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start1 Dec 2017
- Primary completion30 Jun 2018 (estimated)
- Study completion30 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mental DisorderStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mariane Bagatin Bermudez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mariane Bagatin Bermudez, Hospital de Clinicas de Porto Alegre
- Investigators
- Carolina Blaya, Study director, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518411
- Sponsor's protocol ID
- 73658817.3.1001.5327
- Acronym
- UP
- Status last verified
- May 2018
- First submitted
- 14 Dec 2017
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21437675Goebert 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.
PubMed 19174678Guille 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.
PubMed 26535958Rotenstein 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.
PubMed 27923088Bentley 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.
PubMed 29029563
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of the One-session CBT Protocol for Prevention of Mental Illness for Brazilian Portuguese: Open Clinical Trial
- ClinicalTrials.gov ID
- NCT03518411
- Acronym / sponsor ID
- UP / 73658817.3.1001.5327
- Conditions
- Mental Disorder, CBT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Mariane Bagatin BermudezUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Jun 2018 (estimated)
- Study completion
- 30 Nov 2018 (estimated)
- First posted
- 8 May 2018 (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.
- 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
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medical Students | Experimental | Other: Cognitive Behavioral TherapyCognitive Behavioral Therapy Protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- be medical student
- be over 18 years of age
- agree to the Term of Free and Informed Consent.
Key exclusion criteria (1 listed)
- Students with psychotic illness, severe depression, manic episode or acute psychiatric risk.
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 |
|---|---|---|
| Cognitive Behavioral TherapyOne-Session Unified Protocol | Other | Medical Students |
Primary outcome
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.
1 secondary outcome
Prevention of depression symptoms
Time frame: 90 days after
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
- Background: PubMed 21437675Fisak 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.
- Background: PubMed 19174678Goebert 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.
- Background: PubMed 26535958Guille 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.
- Background: PubMed 27923088Rotenstein 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 publication: PubMed 29029563Bentley 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.
- Individual participant dataSharing planned: Undecided
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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.
Carolina Blaya study director
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy in people with Mental Disorder and CBT, run by Mariane Bagatin Bermudez at 1 site in Brazil.
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 3 inclusion and 1 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 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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 Mariane Bermudez, MD (55 51 999554322, bagatinmariane@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of anxiety symptoms (time frame: 90 days after). 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 NCT03518411, which also lists 5 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 8 May 2018.