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

Status Recruiting

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT04852770
• Study type: Interventional
• Source: Fundação Bahiana de Infectologia
• Contact: Irismar Reis de Oliveira, MD, PhD
• Phone: 5571999561137
• Email: irismar@ufba.br
• Status: Recruiting
• Phase: N/A
• Start date: April 23, 2021
• Completion date: November 30, 2021