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

Study Overview
=================
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.

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

Conditions
-----------------
Posttraumatic Stress Disorder, Covid19

Intervention / Treatment
-----------------
* Behavioral: Trial-Based Cognitive Therapy
* Behavioral: Mindfulness-Based Health Promotion
* Behavioral: Positive psychotherapy


Participation Criteria
=================
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trial-Based Cognitive Therapy<br>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<br>* 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.<br>* Other names: TBCT;|
| Active Comparator: Mindfulness-Based Health Promotion<br>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<br>* 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.<br>* Other names: MBHP;|
| Active Comparator: Positive psychotherapy<br>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<br>* 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.<br>* Other names: PPT;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cognitive-Behavior Therapy, Trial-Based Cognitive Therapy, Mindfulness Based Health Promotion, Positive Psychotherapy, PTSD, Covid 19, Randomized clinical trial