Efficacy of TBCT, MBHP and PPT for PTSD During the Covid-19 Pandemics

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04852770
• Other study ID #: FundacaoBI
• Status: Recruiting
• Phase: N/A
• Start date: April 23, 2021
• Est. completion date: November 30, 2021

Study information

• Verified date: March 2021
• Source: Fundação Bahiana de Infectologia
• Contact: Irismar Reis de Oliveira, MD, PhD
• Phone: 5571999561137
• Email: irismar[@]ufba.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 135
• Est. completion date: November 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Covid19
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Brazil	Universidade Federal de Pernambuco	Recife	Pernambuco
Brazil	Universidade Federal da Bahia	Salvador	Bahia
Brazil	Universidade Federal da Bahia	Salvador	Bahia
Brazil	Universidade Federal de São Paulo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Fundação Bahiana de Infectologia	Mente Aberta

Country where clinical trial is conducted

Brazil, 

References & Publications (14)

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):137 — View 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 — View Citation

de Oliveira IR, Powell VB, Wenzel A, Caldas M, Seixas C, Almeida C, Bonfim T, Grangeon MC, Castro M, Galvão 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 — View 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. — View 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. — View Citation

Duckworth AL, Steen TA, Seligman ME. Positive psychology in clinical practice. Annu Rev Clin Psychol. 2005;1:629-51. Review. — View Citation

Duran ÉP, Corchs F, Vianna A, Araújo ÁC, Del Real N, Silva C, Ferreira AP, De Vitto Francez P, Godói 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 effi — View 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 ra — View 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. — View 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 — View 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. — View Citation

Powell VB, Oliveira OH, Seixas C, Almeida C, Grangeon MC, Caldas M, Bonfim TD, Castro M, Galvão-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 r — View 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. — View 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 — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Structured Clinical Interview for DSM-5 - SCID	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).	Baseline
Other	Posttraumatic stress disorder checklist for DSM-5 (PCL-5)	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).	Baseline.
Other	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)	Week 7.
Other	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)	6 months.
Other	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)	12 months.
Other	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)	18 months.
Other	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).	Week 7.
Other	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).	6 months
Other	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).	12 months
Other	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).	18 months
Other	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.	Week 7.
Other	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.	6 months.
Other	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.	12 months.
Other	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.	18 months.
Other	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).	Week 7.
Other	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).	6 months.
Other	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).	12 months.
Other	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).	18 months.
Other	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)	Week 7.
Other	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)	6 months
Other	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)	12 months
Other	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)	18 months
Other	Semi-structured interview regarding online psychotherapy and pandemics.	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.	Week 14.
Primary	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)	Baseline and week 14.
Secondary	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).	Baseline and week 14.
Secondary	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).	From baseline to post-treatment, up 14 weeks.
Secondary	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.	Baseline and week 14.
Secondary	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).	Baseline and week 14.
Secondary	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)	Baseline and week 14.
Secondary	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.	From baseline to post-treatment, up to 14 weeks.