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

Not Applicable

Terminated

• Conditions: Posttraumatic Stress Disorder; Covid19

• 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

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 da Bahia; 🇧🇷 Salvador, Bahia, Brazil

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

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