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

Not Applicable

Terminated

• Conditions: Posttraumatic Stress Disorder; Covid19
• Interventions: Behavioral: Positive psychotherapy; Behavioral: Trial-Based Cognitive Therapy; Behavioral: Mindfulness-Based Health Promotion

• Registration Number: NCT04852770
• Lead Sponsor: Fundação Bahiana de Infectologia

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.

Study Timeline

• Study Start: 2020-04-06
• Study First Submitted: 2020-12-22
• Study First Submitted QC: 2021-04-20
• Study First Posted: 2021-04-21
• Primary Completion: 2023-06-21
• Study Completion: 2023-07-18
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

Not provided

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Positive psychotherapy	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).
Trial-Based Cognitive Therapy	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).
Mindfulness-Based Health Promotion	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).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (3)

Universidade Federal de São Paulo; 🇧🇷 São Paulo, Brazil

Universidade Federal da Bahia; 🇧🇷 Salvador, Bahia, Brazil

Universidade Federal de Pernambuco; 🇧🇷 Recife, Pernambuco, Brazil