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

Sponsor

Fundação Bahiana de Infectologia (Other)

Overall Status

Recruiting

CT.gov ID

NCT04852770

Collaborator

Mente Aberta (Other)

135

Enrollment

Locations

Arms

7.3

Anticipated Duration (Months)

33.8

Patients Per Site

4.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorder Covid19	Behavioral: Trial-Based Cognitive Therapy Behavioral: Mindfulness-Based Health Promotion Behavioral: Positive psychotherapy	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

135 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized clinical trialRandomized clinical trial

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Apr 23, 2021

Anticipated Primary Completion Date :

Sep 30, 2021

Anticipated Study Completion Date :

Nov 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	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. Other Names: TBCT
Active Comparator: 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).	Behavioral: 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. Other Names: MBHP
Active Comparator: 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).	Behavioral: 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 Names: PPT

Arm

Intervention/Treatment

Experimental: 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).

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.

Other Names:

TBCT

Active Comparator: 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).

Behavioral: 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.

Other Names:

MBHP

Active Comparator: 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).

Behavioral: 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 Names:

PPT

Outcome Measures

Primary Outcome Measures

The Clinician-Administered PTSD Scale (CAPS-5) [Baseline and week 14.]
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) [Baseline and week 14.]
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) [From baseline to post-treatment, up 14 weeks.]
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) [Baseline and week 14.]
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) [Baseline and week 14.]
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) [Baseline and week 14.]
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) [From baseline to post-treatment, up to 14 weeks.]
It is a scale that assess four components of therapeuthic alliance: work, relation, comprehension of therapist and objectives of treatment for the patient.

Other Outcome Measures

Structured Clinical Interview for DSM-5 - SCID [Baseline]
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).
Posttraumatic stress disorder checklist for DSM-5 (PCL-5) [Baseline.]
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).
The Clinician-Administered PTSD Scale (CAPS-5) [Week 7.]
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)
The Clinician-Administered PTSD Scale (CAPS-5) [6 months.]
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)
The Clinician-Administered PTSD Scale (CAPS-5) [12 months.]
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)
The Clinician-Administered PTSD Scale (CAPS-5) [18 months.]
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)
Hospital Anxiety and Depression Scale (HADS) [Week 7.]
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) [6 months]
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) [12 months]
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) [18 months]
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) [Week 7.]
This is a 32-item questionnaire assessing the cognitive and emotional aspects of guilt which are associated to a specific traumatic event.
Trauma-Related Guilt Inventory (TRGI) [6 months.]
This is a 32-item questionnaire assessing the cognitive and emotional aspects of guilt which are associated to a specific traumatic event.
Trauma-Related Guilt Inventory (TRGI) [12 months.]
This is a 32-item questionnaire assessing the cognitive and emotional aspects of guilt which are associated to a specific traumatic event.
Trauma-Related Guilt Inventory (TRGI) [18 months.]
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) [Week 7.]
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).
Negative Core Beliefs Inventory (NCBI) [6 months.]
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).
Negative Core Beliefs Inventory (NCBI) [12 months.]
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).
Negative Core Beliefs Inventory (NCBI) [18 months.]
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) [Week 7.]
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)
The World Health Organization Five Well-being index (WHO-5) [6 months]
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)
The World Health Organization Five Well-being index (WHO-5) [12 months]
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)
The World Health Organization Five Well-being index (WHO-5) [18 months]
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)
Semi-structured interview regarding online psychotherapy and pandemics. [Week 14.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidade Federal da Bahia	Salvador	Bahia	Brazil	40110-906
2	Universidade Federal da Bahia	Salvador	Bahia	Brazil	40110-906
3	Universidade Federal de Pernambuco	Recife	Pernambuco	Brazil	50670-901
4	Universidade Federal de São Paulo	São Paulo		Brazil	04021-001