Back to resultsEfficacy of TBCT, MBHP and PPT for PTSD During the Covid-19 Pandemics
Primary Purpose
Posttraumatic Stress Disorder, Covid19
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Trial-Based Cognitive Therapy
Mindfulness-Based Health Promotion
Positive psychotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Cognitive-Behavior Therapy, Trial-Based Cognitive Therapy, Mindfulness Based Health Promotion, Positive Psychotherapy, PTSD, Covid 19, Randomized clinical trial
Eligibility Criteria
Inclusion criteria:
- both sexes;
- aged 18 to 60 years;
- scoring 45 or more on the PCL-5
- PTSD developed (or aggravated by) as a result of direct or indirect exposure to COVID-19 [e.g., health professionals, people who tested positive for Covid-19 (or their relative or close friends), or those who quarantined, isolated or socially distanced themselves];
- Participants should be able to read, write and follow instructions, and have access to the a stable internet connexion.
Exclusion Criteria:
- severe suicide risk (plans, attitudes or suicide attemps for the last 12 months);
- self-mutilation behavior (for the last 12 months);
- already in psychotherapy;
- psychotic symptoms;
- current substance abuse or addiction (last 12 months).
Sites / Locations
- Universidade Federal da BahiaRecruiting
- Universidade Federal da BahiaRecruiting
- Universidade Federal de PernambucoRecruiting
- Universidade Federal de São PauloRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Trial-Based Cognitive Therapy
Mindfulness-Based Health Promotion
Positive psychotherapy
Arm Description
TBCT (de Oliveira, 2008) is a novel transdiagnostic approach (Wenzel, 2017). It has been shown to be effective for depression (Hemanny et al., 2019), social anxiety disorder (Neufeld et al., 2020; Caetano et al., 2018; de Oliveira et al., 2011; Powell et al., 2013), and PTSD (Duran et al., 2020). TBCT differs from other CBT approaches in that it introduces a new, organized, and systematic approach to change dysfunctional negative core beliefs, and allows cognitive, emotional, and experiential work to be done simultaneously (de Oliveira, 2016). Interestingly, it incorporates a courtroom metaphor to challenge dysfunctional core beliefs conceptualized as self-accusations (de Oliveira, 2016). TBCT is an example of assimilative psychotherapy integration that relies on Beckian CBT (de Oliveira, 2016). It incorporates and integrates components of other psychotherapies (Delavechia et al., 2016).
The Mindfulness-Based Stress Reduction (MBSR) program was created by Jon Kabat-Zinn and colleagues at the University of Massachusetts Medical Center in 1979, and it is an intervention whose effects on mental health and quality of life has produced several studies worldwide, both in clinical and non-clinical populations. Several protocols have been developed based on the MBSR aimed at specific publics, such as the Mindfulness-Based Health Promotion (MBHP) program developed by the Mente Aberta - Brazilian Center for Mindfulness and Health Promotion. The MBHP program was inspired by the original MBSR model but adapted to the context of the Brazilian Health Care (SUS) system, addressing chronic conditions and mental disorders as well (TROMBKA et al., 2018; LOPES et al., 2019; SALVO et al., 2018).
Positive psychotherapy (PPT) seeks to understand positive emotions, psychological potentialities and healthy human / social / institutional functioning, and to apply this knowledge to help people and institutions, with a focus on prevention and promotion of mental health (SELIGMAN et al., 2005). Originally, PP focused on happiness and subjective well-being (SELIGMAN, 2010; SELIGMAN; CSIKSZENTMIHALYI, 2000). Then, the studies gained a broader view of psychological well-being and another similar proposal entitled PERMA, which is composed of the following five spheres: positive emotions - P; engagement - E; relationships - R; meaning - M; and achievement - A. (RYFF, 2013; SELIGMAN, 2012). Although positive psychology aims to be a way of looking at life, some psychotherapeutic proposals, such as positive psychotherapy (PPT), have been developed, and clinical studies have been replicated in different clinical and cultural contexts (RASHID; SELIGMAN, 2019; RICHES et al., 2016).
Outcomes
Primary Outcome Measures
The Clinician-Administered PTSD Scale (CAPS-5)
It is a diagnostic interview scale with 30 items to assess the diagnosis and the severity of PTSD symptoms according to DSM-5 (Weathers et al., 2018)
Secondary Outcome Measures
Hospital Anxiety and Depression Scale (HADS)
This is a fourteen-item scale used to assess anxiety and depression symptoms, where each item scores 0 to 3 points, and a total score of 9 or higher suggests mild symptoms. It was translated and validated for the Brazilian population. (Faro, 2015; Zigmond e Snaith, 1983).
Hospital Anxiety and Depression Scale (HADS)
This is a fourteen-item scale used to assess anxiety and depression symptoms, where each item scores 0 to 3 points, and a total score of 9 or higher suggests mild symptoms. It was translated and validated for the Brazilian population. (Faro, 2015; Zigmond e Snaith, 1983).
Trauma-Related Guilt Inventory (TRGI)
This is a 32-item questionnaire assessing the cognitive and emotional aspects of guilt which are associated to a specific traumatic event.
Negative Core Beliefs Inventory (NCBI)
Designed to assess negative core beliefs, as described by Beck (2005); it consists of 50 items evaluating beliefs about oneself and other people, on a likert scale of 1 to 4 points each (Osmo, 2017).
The World Health Organization Five Well-being index (WHO-5)
Overall well-being scale, with five questions and scores ranging from 0-5, addressing mood and energy (TOPP et al., 2015; DADFAR, 2018). The WHO-5 validation study into Brazilian Portuguese included 1,128 individuals. In this study, the instrument presented good internal validity (Cronbach's alpha = 0,83)
California Psychotherapy Alliance Scale - Patient version (CALPAS-P)
It is a scale that assess four components of therapeuthic alliance: work, relation, comprehension of therapist and objectives of treatment for the patient.
Full Information
NCT ID
NCT04852770
First Posted
December 22, 2020
Last Updated
April 20, 2021
Sponsor
Fundação Bahiana de Infectologia
Collaborators
Mente Aberta
1. Study Identification
Unique Protocol Identification Number
NCT04852770
Brief Title
Efficacy of TBCT, MBHP and PPT for PTSD During the Covid-19 Pandemics
Official Title
A Randomized Clinical Trial to Assess the Efficacy of Online-delivered Treatment With Trial-based Cognitive Therapy, Mindfulness-based Health Promotion and Positive Psychotherapy for Post-traumatic Stress Disorder During the Covid-19 Pandemics
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 23, 2021 (Anticipated)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
November 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundação Bahiana de Infectologia
Collaborators
Mente Aberta
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
The psychotherapies to be assessed in the present study, delivered on-line, are: trial-based cognitive therapy (TBCT), mindfulness-based health promotion (MBHP), and positive psychotherapy (PPT). Objectives: 1) to assess the efficacy of TBCT compared to MBHP and PPT in reducing the symptoms of PTSD during the COVID-19 pandemic.
Detailed Description
Background: Research has suggested the use of different forms of psychotherapy to decrease drop-out rates in the post-traumatic stress disorder (PTSD) treatment. The psychotherapies to be assessed in the present study are: trial-based cognitive therapy (TBCT), mindfulness-based health promotion (MBHP) and Positive psychotherapy (PPT). Objectives: Our objectives are: 1) to assess the efficacy of TBCT compared to MBHP and PPT to reduce the symptoms of PTSD in the context of the COVID-19 pandemic, all delivered online; 2) to compare the efficacy of these psychotherapies in reducing symptoms of anxiety and depression, and in improving well-being; 3) to describe how patients and professionals perceive teletherapy. Methods: This is a three-arm, randomized, multicenter, single-blind, clinical trial. An estimated sample of 135 patients will receive either TBCT, MBHP or PPT, individual, weekly visits, totaling thirteen sessions. The primary outcome measure will be the CAPS-5, and the secondary outcome measures will be the Hospital Anxiety and Depression Scale (HADS), the Negative Core Beliefs Inventory (NCBI), and the Trauma-Related Guilt Inventory (TRGI). Other measures are the WHO-5 Well-being Index (WHO-5), and the California Psychotherapy Alliance Scale (CALPAS-P). Also, questions about patients perception of teletherapy will be asked. Expected results: PTSD symptoms are expected to be reduced after TBCT, MBHP and PPT. The null hypothesis is that no statistical difference is expected to be found among the three psychotherapies, as opposed to the alternative hypothesis that TBCT and MBHP are superior to PPT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Covid19
Keywords
Cognitive-Behavior Therapy, Trial-Based Cognitive Therapy, Mindfulness Based Health Promotion, Positive Psychotherapy, PTSD, Covid 19, Randomized clinical trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
135 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Trial-Based Cognitive Therapy
Arm Type
Experimental
Arm Description
TBCT (de Oliveira, 2008) is a novel transdiagnostic approach (Wenzel, 2017). It has been shown to be effective for depression (Hemanny et al., 2019), social anxiety disorder (Neufeld et al., 2020; Caetano et al., 2018; de Oliveira et al., 2011; Powell et al., 2013), and PTSD (Duran et al., 2020). TBCT differs from other CBT approaches in that it introduces a new, organized, and systematic approach to change dysfunctional negative core beliefs, and allows cognitive, emotional, and experiential work to be done simultaneously (de Oliveira, 2016). Interestingly, it incorporates a courtroom metaphor to challenge dysfunctional core beliefs conceptualized as self-accusations (de Oliveira, 2016). TBCT is an example of assimilative psychotherapy integration that relies on Beckian CBT (de Oliveira, 2016). It incorporates and integrates components of other psychotherapies (Delavechia et al., 2016).
Arm Title
Mindfulness-Based Health Promotion
Arm Type
Active Comparator
Arm Description
The Mindfulness-Based Stress Reduction (MBSR) program was created by Jon Kabat-Zinn and colleagues at the University of Massachusetts Medical Center in 1979, and it is an intervention whose effects on mental health and quality of life has produced several studies worldwide, both in clinical and non-clinical populations. Several protocols have been developed based on the MBSR aimed at specific publics, such as the Mindfulness-Based Health Promotion (MBHP) program developed by the Mente Aberta - Brazilian Center for Mindfulness and Health Promotion. The MBHP program was inspired by the original MBSR model but adapted to the context of the Brazilian Health Care (SUS) system, addressing chronic conditions and mental disorders as well (TROMBKA et al., 2018; LOPES et al., 2019; SALVO et al., 2018).
Arm Title
Positive psychotherapy
Arm Type
Active Comparator
Arm Description
Positive psychotherapy (PPT) seeks to understand positive emotions, psychological potentialities and healthy human / social / institutional functioning, and to apply this knowledge to help people and institutions, with a focus on prevention and promotion of mental health (SELIGMAN et al., 2005). Originally, PP focused on happiness and subjective well-being (SELIGMAN, 2010; SELIGMAN; CSIKSZENTMIHALYI, 2000). Then, the studies gained a broader view of psychological well-being and another similar proposal entitled PERMA, which is composed of the following five spheres: positive emotions - P; engagement - E; relationships - R; meaning - M; and achievement - A. (RYFF, 2013; SELIGMAN, 2012). Although positive psychology aims to be a way of looking at life, some psychotherapeutic proposals, such as positive psychotherapy (PPT), have been developed, and clinical studies have been replicated in different clinical and cultural contexts (RASHID; SELIGMAN, 2019; RICHES et al., 2016).
Intervention Type
Behavioral
Intervention Name(s)
Trial-Based Cognitive Therapy
Other Intervention Name(s)
TBCT
Intervention Description
TBCT is an approach that includes psychoeducation and cognitive restructuring techniques concerning automatic thoughts, underlying assumptions and core beliefs related to the traumatic events. It is conducted in a therapeutic setting that makes use of experiential techniques, allowing the patient to refer to him/herself in the third person and thus taking distance from him or herself. One of TBCT techniques for dealing with guilt and shame, emotions that provoke great limitation to patients with PTSD, is the participation grid (PG). Another important technique is the consensual role-play (CRP), designed to help patients resolve ambivalence and make decisions. In addition, the most important TBCT technique, the Trial, was developed to help patients change dysfunctional negative core beliefs. Therapists who will conduct this approach have a specialization level in CBT. In this study, this treatment will be delivered in 14 sessions, weekly, individualy, one session by week and on line.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Health Promotion
Other Intervention Name(s)
MBHP
Intervention Description
The MBHP protocol is a structured program developed over 8 sessions, in group, where participants (8-15 people) meet every week for 2 hours (standard duration of one session), to experience the concepts and techniques of mindfulness. Participants are also given suggestions of daily activities to be implemented at home or in the workplace, that last in average 15-20 minutes, but may last up to 45 minutes in the case of more motivated and compliant participants. They are also encouraged to incorporate the idea of Mindfulness in their daily lives (the so-called "informal practice"), so that all daily activities somehow become opportunities to practice Mindfulness. In this study, this treatment will be delivered in 14 sessions, weekly, individualy, one session by week and on line.
Intervention Type
Behavioral
Intervention Name(s)
Positive psychotherapy
Other Intervention Name(s)
PPT
Intervention Description
PPT is the clinical and therapeutic work derived from PP. PPT consists of 15 specific practices that have been empirically validated, either separately, or in conjunction with two or three practices. After empirical validation, these practices were organized in a cohesive protocol of 15 sessions called PPT. Many of these practices have been studied through online interventions. In the present study, the protocol will be reduced to 14 sessions, with sessions called positive relationships, positive communication, and practical wisdom removed. It was understood that the other 12 would be more easily adapted to the moment of the study. (DUCKWORTH; STEEN; SELIGMAN, 2005; MONGRAIN; ANSELMO-MATTHEWS, 2012; RASHID; SELIGMAN, 2019). In this study, this treatment will be delivered in 14 sessions, weekly, individualy, one session by week and on line.
Primary Outcome Measure Information:
Title
The Clinician-Administered PTSD Scale (CAPS-5)
Description
It is a diagnostic interview scale with 30 items to assess the diagnosis and the severity of PTSD symptoms according to DSM-5 (Weathers et al., 2018)
Time Frame
Baseline and week 14.
Secondary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale (HADS)
Description
This is a fourteen-item scale used to assess anxiety and depression symptoms, where each item scores 0 to 3 points, and a total score of 9 or higher suggests mild symptoms. It was translated and validated for the Brazilian population. (Faro, 2015; Zigmond e Snaith, 1983).
Time Frame
Baseline and week 14.
Title
Hospital Anxiety and Depression Scale (HADS)
Description
This is a fourteen-item scale used to assess anxiety and depression symptoms, where each item scores 0 to 3 points, and a total score of 9 or higher suggests mild symptoms. It was translated and validated for the Brazilian population. (Faro, 2015; Zigmond e Snaith, 1983).
Time Frame
From baseline to post-treatment, up 14 weeks.
Title
Trauma-Related Guilt Inventory (TRGI)
Description
This is a 32-item questionnaire assessing the cognitive and emotional aspects of guilt which are associated to a specific traumatic event.
Time Frame
Baseline and week 14.
Title
Negative Core Beliefs Inventory (NCBI)
Description
Designed to assess negative core beliefs, as described by Beck (2005); it consists of 50 items evaluating beliefs about oneself and other people, on a likert scale of 1 to 4 points each (Osmo, 2017).
Time Frame
Baseline and week 14.
Title
The World Health Organization Five Well-being index (WHO-5)
Description
Overall well-being scale, with five questions and scores ranging from 0-5, addressing mood and energy (TOPP et al., 2015; DADFAR, 2018). The WHO-5 validation study into Brazilian Portuguese included 1,128 individuals. In this study, the instrument presented good internal validity (Cronbach's alpha = 0,83)
Time Frame
Baseline and week 14.
Title
California Psychotherapy Alliance Scale - Patient version (CALPAS-P)
Description
It is a scale that assess four components of therapeuthic alliance: work, relation, comprehension of therapist and objectives of treatment for the patient.
Time Frame
From baseline to post-treatment, up to 14 weeks.
Other Pre-specified Outcome Measures:
Title
Structured Clinical Interview for DSM-5 - SCID
Description
It is a semi-structured psychiatric interview, with the purpose of providing a diagnosis, according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
Time Frame
Baseline
Title
Posttraumatic stress disorder checklist for DSM-5 (PCL-5)
Description
It contains 20 items with the purpose of assessing PTSD symptoms, in accordance with criteria B, C, D and E (DSM-5). Each item is scored in a scale that ranges from 0 (not at all) to 4 (extremely).
Time Frame
Baseline.
Title
The Clinician-Administered PTSD Scale (CAPS-5)
Description
It is a diagnostic interview scale with 30 items to assess the diagnosis and the severity of PTSD symptoms according to DSM-5 (Weathers et al., 2018)
Time Frame
Week 7.
Title
The Clinician-Administered PTSD Scale (CAPS-5)
Description
It is a diagnostic interview scale with 30 items to assess the diagnosis and the severity of PTSD symptoms according to DSM-5 (Weathers et al., 2018)
Time Frame
6 months.
Title
The Clinician-Administered PTSD Scale (CAPS-5)
Description
It is a diagnostic interview scale with 30 items to assess the diagnosis and the severity of PTSD symptoms according to DSM-5 (Weathers et al., 2018)
Time Frame
12 months.
Title
The Clinician-Administered PTSD Scale (CAPS-5)
Description
It is a diagnostic interview scale with 30 items to assess the diagnosis and the severity of PTSD symptoms according to DSM-5 (Weathers et al., 2018)
Time Frame
18 months.
Title
Hospital Anxiety and Depression Scale (HADS)
Description
This is a fourteen-item scale used to assess anxiety and depression symptoms, where each item scores 0 to 3 points, and a total score of 9 or higher suggests mild symptoms. It was translated and validated for the Brazilian population. (Faro, 2015; Zigmond e Snaith, 1983).
Time Frame
Week 7.
Title
Hospital Anxiety and Depression Scale (HADS)
Description
This is a fourteen-item scale used to assess anxiety and depression symptoms, where each item scores 0 to 3 points, and a total score of 9 or higher suggests mild symptoms. It was translated and validated for the Brazilian population. (Faro, 2015; Zigmond e Snaith, 1983).
Time Frame
6 months
Title
Hospital Anxiety and Depression Scale (HADS)
Description
This is a fourteen-item scale used to assess anxiety and depression symptoms, where each item scores 0 to 3 points, and a total score of 9 or higher suggests mild symptoms. It was translated and validated for the Brazilian population. (Faro, 2015; Zigmond e Snaith, 1983).
Time Frame
12 months
Title
Hospital Anxiety and Depression Scale (HADS)
Description
This is a fourteen-item scale used to assess anxiety and depression symptoms, where each item scores 0 to 3 points, and a total score of 9 or higher suggests mild symptoms. It was translated and validated for the Brazilian population. (Faro, 2015; Zigmond e Snaith, 1983).
Time Frame
18 months
Title
Trauma-Related Guilt Inventory (TRGI)
Description
This is a 32-item questionnaire assessing the cognitive and emotional aspects of guilt which are associated to a specific traumatic event.
Time Frame
Week 7.
Title
Trauma-Related Guilt Inventory (TRGI)
Description
This is a 32-item questionnaire assessing the cognitive and emotional aspects of guilt which are associated to a specific traumatic event.
Time Frame
6 months.
Title
Trauma-Related Guilt Inventory (TRGI)
Description
This is a 32-item questionnaire assessing the cognitive and emotional aspects of guilt which are associated to a specific traumatic event.
Time Frame
12 months.
Title
Trauma-Related Guilt Inventory (TRGI)
Description
This is a 32-item questionnaire assessing the cognitive and emotional aspects of guilt which are associated to a specific traumatic event.
Time Frame
18 months.
Title
Negative Core Beliefs Inventory (NCBI)
Description
Designed to assess negative core beliefs, as described by Beck (2005); it consists of 50 items evaluating beliefs about oneself and other people, on a likert scale of 1 to 4 points each (Osmo, 2017).
Time Frame
Week 7.
Title
Negative Core Beliefs Inventory (NCBI)
Description
Designed to assess negative core beliefs, as described by Beck (2005); it consists of 50 items evaluating beliefs about oneself and other people, on a likert scale of 1 to 4 points each (Osmo, 2017).
Time Frame
6 months.
Title
Negative Core Beliefs Inventory (NCBI)
Description
Designed to assess negative core beliefs, as described by Beck (2005); it consists of 50 items evaluating beliefs about oneself and other people, on a likert scale of 1 to 4 points each (Osmo, 2017).
Time Frame
12 months.
Title
Negative Core Beliefs Inventory (NCBI)
Description
Designed to assess negative core beliefs, as described by Beck (2005); it consists of 50 items evaluating beliefs about oneself and other people, on a likert scale of 1 to 4 points each (Osmo, 2017).
Time Frame
18 months.
Title
The World Health Organization Five Well-being index (WHO-5)
Description
Overall well-being scale, with five questions and scores ranging from 0-5, addressing mood and energy (TOPP et al., 2015; DADFAR, 2018). The WHO-5 validation study into Brazilian Portuguese included 1,128 individuals. In this study, the instrument presented good internal validity (Cronbach's alpha = 0,83)
Time Frame
Week 7.
Title
The World Health Organization Five Well-being index (WHO-5)
Description
Overall well-being scale, with five questions and scores ranging from 0-5, addressing mood and energy (TOPP et al., 2015; DADFAR, 2018). The WHO-5 validation study into Brazilian Portuguese included 1,128 individuals. In this study, the instrument presented good internal validity (Cronbach's alpha = 0,83)
Time Frame
6 months
Title
The World Health Organization Five Well-being index (WHO-5)
Description
Overall well-being scale, with five questions and scores ranging from 0-5, addressing mood and energy (TOPP et al., 2015; DADFAR, 2018). The WHO-5 validation study into Brazilian Portuguese included 1,128 individuals. In this study, the instrument presented good internal validity (Cronbach's alpha = 0,83)
Time Frame
12 months
Title
The World Health Organization Five Well-being index (WHO-5)
Description
Overall well-being scale, with five questions and scores ranging from 0-5, addressing mood and energy (TOPP et al., 2015; DADFAR, 2018). The WHO-5 validation study into Brazilian Portuguese included 1,128 individuals. In this study, the instrument presented good internal validity (Cronbach's alpha = 0,83)
Time Frame
18 months
Title
Semi-structured interview regarding online psychotherapy and pandemics.
Description
It consists of semi-structured questions about the perception of the patient and of the psychotherapist about the conduction of psychotherapy in an on line format, such as: quality of the therapeutic relationship and experience in on line treatment and the effect of pandemics on mental heatlh.
Time Frame
Week 14.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
both sexes;
aged 18 to 60 years;
scoring 45 or more on the PCL-5
PTSD developed (or aggravated by) as a result of direct or indirect exposure to COVID-19 [e.g., health professionals, people who tested positive for Covid-19 (or their relative or close friends), or those who quarantined, isolated or socially distanced themselves];
Participants should be able to read, write and follow instructions, and have access to the a stable internet connexion.
Exclusion Criteria:
severe suicide risk (plans, attitudes or suicide attemps for the last 12 months);
self-mutilation behavior (for the last 12 months);
already in psychotherapy;
psychotic symptoms;
current substance abuse or addiction (last 12 months).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Irismar Reis de Oliveira, MD, PhD
Phone
5571999561137
Email
irismar@ufba.br
First Name & Middle Initial & Last Name or Official Title & Degree
Erica P Duran, PsyD
Phone
5511976642291
Email
ericapduran@gmail.com
Facility Information:
Facility Name
Universidade Federal da Bahia
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40110-906
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irismar Reis De Oliveira, PhD
Phone
+55 71 9956-1137
Email
irismar.oliveira@me.com
Facility Name
Universidade Federal da Bahia
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40110-906
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erica Duran, MSc.
Phone
+55 11 97664-2291
Email
ericapduran@gmail.com
Facility Name
Universidade Federal de Pernambuco
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50670-901
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leonardo Machado
Phone
+55 81 98126-9696
Email
leonardo.machadot@ufpe.br
Facility Name
Universidade Federal de São Paulo
City
São Paulo
ZIP/Postal Code
04021-001
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcelo Demarzo, PhD
Phone
+55 16 98121-4451
Email
marcelodemarzo@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32021616
Citation
Neufeld CB, Palma PC, Caetano KAS, Brust-Renck PG, Curtiss J, Hofmann SG. A randomized clinical trial of group and individual Cognitive-Behavioral Therapy approaches for Social Anxiety Disorder. Int J Clin Health Psychol. 2020 Jan-Apr;20(1):29-37. doi: 10.1016/j.ijchp.2019.11.004. Epub 2019 Dec 24.
Results Reference
result
PubMed Identifier
24142084
Citation
Powell VB, Oliveira OH, Seixas C, Almeida C, Grangeon MC, Caldas M, Bonfim TD, Castro M, Galvao-de Almeida A, Moraes Rde O, Sudak D, de-Oliveira IR. Changing core beliefs with trial-based cognitive therapy may improve quality of life in social phobia: a randomized study. Braz J Psychiatry. 2013 Jul-Sep;35(3):243-7. doi: 10.1590/1516-4446-2012-0863. Erratum In: Rev Bras Psiquiatr. 2013 Dec;35(4):445. Galvao-de Almeida [corrected to Galvao-de Almeida, Amanda].
Results Reference
result
PubMed Identifier
18373017
Citation
Oliveira IR. Trial-Based Thought Record (TBTR): preliminary data on a strategy to deal with core beliefs by combining sentence reversion and the use of analogy with a judicial process. Braz J Psychiatry. 2008 Mar;30(1):12-8. doi: 10.1590/s1516-44462008000100003.
Results Reference
result
PubMed Identifier
21955037
Citation
de Oliveira IR, Powell VB, Wenzel A, Caldas M, Seixas C, Almeida C, Bonfim T, Grangeon MC, Castro M, Galvao A, de Oliveira Moraes R, Sudak D. Efficacy of the trial-based thought record, a new cognitive therapy strategy designed to change core beliefs, in social phobia. J Clin Pharm Ther. 2012 Jun;37(3):328-34. doi: 10.1111/j.1365-2710.2011.01299.x. Epub 2011 Sep 28.
Results Reference
result
PubMed Identifier
31769377
Citation
Hemanny C, Carvalho C, Maia N, Reis D, Botelho AC, Bonavides D, Seixas C, de Oliveira IR. Efficacy of trial-based cognitive therapy, behavioral activation and treatment as usual in the treatment of major depressive disorder: preliminary findings from a randomized clinical trial. CNS Spectr. 2020 Aug;25(4):535-544. doi: 10.1017/S1092852919001457. Epub 2019 Nov 26.
Results Reference
result
PubMed Identifier
22790114
Citation
de Oliveira IR, Hemmany C, Powell VB, Bonfim TD, Duran EP, Novais N, Velasquez M, Di Sarno E, Alves GL, Cesnik JA; Brazilian TBTR Study Group. Trial-based psychotherapy and the efficacy of trial-based thought record in changing unhelpful core beliefs and reducing self-criticism. CNS Spectr. 2012 Mar;17(1):16-23. doi: 10.1017/S1092852912000399.
Results Reference
result
PubMed Identifier
32450928
Citation
Duran EP, Corchs F, Vianna A, Araujo AC, Del Real N, Silva C, Ferreira AP, De Vitto Francez P, Godoi C, Silveira H, Matsumoto L, Gebara CM, de Barros Neto TP, Chilvarquer R, de Siqueira LL, Bernik M, Neto FL. A randomized clinical trial to assess the efficacy of trial-based cognitive therapy compared to prolonged exposure for post-traumatic stress disorder: preliminary findings. CNS Spectr. 2021 Aug;26(4):427-434. doi: 10.1017/S1092852920001455. Epub 2020 May 26.
Results Reference
result
PubMed Identifier
30525996
Citation
Seligman MEP. Positive Psychology: A Personal History. Annu Rev Clin Psychol. 2019 May 7;15:1-23. doi: 10.1146/annurev-clinpsy-050718-095653. Epub 2018 Dec 10.
Results Reference
result
PubMed Identifier
17716102
Citation
Duckworth AL, Steen TA, Seligman ME. Positive psychology in clinical practice. Annu Rev Clin Psychol. 2005;1:629-51. doi: 10.1146/annurev.clinpsy.1.102803.144154.
Results Reference
result
PubMed Identifier
24469930
Citation
Mongrain M, Anselmo-Matthews T. Do positive psychology exercises work? A replication of Seligman et al. (2005). J Clin Psychol. 2012 Apr;68(4):382-9. doi: 10.1002/jclp.21839.
Results Reference
result
PubMed Identifier
26653052
Citation
Bovin MJ, Marx BP, Weathers FW, Gallagher MW, Rodriguez P, Schnurr PP, Keane TM. Psychometric properties of the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (PCL-5) in veterans. Psychol Assess. 2016 Nov;28(11):1379-1391. doi: 10.1037/pas0000254. Epub 2015 Dec 14.
Results Reference
result
PubMed Identifier
29801444
Citation
Trombka M, Demarzo M, Bacas DC, Antonio SB, Cicuto K, Salvo V, Claudino FCA, Ribeiro L, Christopher M, Garcia-Campayo J, Rocha NS. Study protocol of a multicenter randomized controlled trial of mindfulness training to reduce burnout and promote quality of life in police officers: the POLICE study. BMC Psychiatry. 2018 May 25;18(1):151. doi: 10.1186/s12888-018-1726-7.
Results Reference
result
PubMed Identifier
21458165
Citation
de Oliveira IR. Kafka's trial dilemma: proposal of a practical solution to Joseph K.'s unknown accusation. Med Hypotheses. 2011 Jul;77(1):5-6. doi: 10.1016/j.mehy.2011.03.010. Epub 2011 Mar 31.
Results Reference
result
PubMed Identifier
21912931
Citation
de Souza CM, Hidalgo MP. World Health Organization 5-item well-being index: validation of the Brazilian Portuguese version. Eur Arch Psychiatry Clin Neurosci. 2012 Apr;262(3):239-44. doi: 10.1007/s00406-011-0255-x. Epub 2011 Sep 7.
Results Reference
result
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Efficacy of TBCT, MBHP and PPT for PTSD During the Covid-19 Pandemics
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