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

Last updated: April 1, 2025
Sponsor: Fundação Bahiana de Infectologia
Overall Status: Terminated

Phase

N/A

Condition

Covid-19

Post-traumatic Stress Disorders

Treatment

Mindfulness-Based Health Promotion

Trial-Based Cognitive Therapy

Positive psychotherapy

Clinical Study ID

NCT04852770
FundacaoBI
  • Ages 18-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 toCOVID-19 [e.g., health professionals, people who tested positive for Covid-19 (ortheir relative or close friends), or those who quarantined, isolated or sociallydistanced themselves];

  • Participants should be able to read, write and follow instructions, and have accessto the a stable internet connexion.

Exclusion

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

Total Participants: 135
Treatment Group(s): 3
Primary Treatment: Mindfulness-Based Health Promotion
Phase:
Study Start date:
April 06, 2020
Estimated Completion Date:
July 18, 2023

Study 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.

Connect with a study center

  • Universidade Federal da Bahia

    Salvador, Bahia 40110-906
    Brazil

    Site Not Available

  • Universidade Federal de Pernambuco

    Recife, Pernambuco 50670-901
    Brazil

    Site Not Available

  • Universidade Federal de São Paulo

    São Paulo, 04021-001
    Brazil

    Site Not Available

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