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

Fundação Bahiana de Infectologia

Status: Terminated

Conditions: Posttraumatic Stress Disorder; Covid19

Treatments: Behavioral: Trial-Based Cognitive Therapy; Behavioral: Mindfulness-Based Health Promotion; Behavioral: Positive psychotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04852770

FundacaoBI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 135 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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135 participants in 3 patient groups

Trial-Based Cognitive Therapy

Experimental group

Description:

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).

Treatment:

Behavioral: Trial-Based Cognitive Therapy

Mindfulness-Based Health Promotion

Active Comparator group

Description:

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).

Treatment:

Behavioral: Mindfulness-Based Health Promotion

Positive psychotherapy

Active Comparator group

Description:

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).

Treatment:

Behavioral: Positive psychotherapy