Efficacy of TBCT, MBHP and PPT for PTSD During the Covid-19 Pandemics
NCT ID: NCT04852770
Last Updated: 2025-04-04
Study Results
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Basic Information
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TERMINATED
NA
135 participants
INTERVENTIONAL
2020-04-06
2023-07-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Trial-Based Cognitive Therapy
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).
Trial-Based Cognitive Therapy
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.
Mindfulness-Based Health Promotion
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).
Mindfulness-Based Health Promotion
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.
Positive psychotherapy
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).
Positive psychotherapy
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.
Interventions
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Trial-Based Cognitive Therapy
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.
Mindfulness-Based Health Promotion
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.
Positive psychotherapy
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* self-mutilation behavior (for the last 12 months);
* already in psychotherapy;
* psychotic symptoms;
* current substance abuse or addiction (last 12 months).
18 Years
60 Years
ALL
No
Sponsors
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Mente Aberta
OTHER
Fundação Bahiana de Infectologia
OTHER
Responsible Party
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Principal Investigators
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Irismar Reis de Oliveira, MD, PhD
Role: STUDY_DIRECTOR
Federal University of Bahia
Locations
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Universidade Federal da Bahia
Salvador, Estado de Bahia, Brazil
Universidade Federal de Pernambuco
Recife, Pernambuco, Brazil
Universidade Federal de São Paulo
São Paulo, São Paulo, Brazil
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Study Documents
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Document Type: Study Protocol
Duran, É. P., Hemanny, C., Vieira, R., Nascimento, O., Machado, L., de Oliveira, I. R., \& Demarzo, M. (2022). A Randomized Clinical Trial to Assess the Efficacy of Online-Treatment with Trial-Based Cognitive Therapy, Mindfulness-Based Health Promotion and Positive Psychotherapy for Post-Traumatic Stress Disorder during the COVID-19 Pandemic: A Study Protocol. International Journal of Environmental Research and Public Health, 19(2), 819.
View DocumentOther Identifiers
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FundacaoBI
Identifier Type: -
Identifier Source: org_study_id
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