A Randomized Clinical Trial to Assess the Efficacy of Online Treatment With Trial-based Cognitive Therapy, Mindfulness-based Health Promotion and Positive Psychotherapy for Post-traumatic Stress Disorder During the Covid-19 Pandemics
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Posttraumatic Stress Disorder
- Sponsor
- Fundação Bahiana de Infectologia
- Enrollment
- 135
- Locations
- 3
- Primary Endpoint
- The Clinician-Administered PTSD Scale (CAPS-5)
- Status
- Terminated
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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).
Outcomes
Primary Outcomes
The Clinician-Administered PTSD Scale (CAPS-5)
Time Frame: 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 Outcomes
- Hospital Anxiety and Depression Scale (HADS)(From baseline to post-treatment, up 14 weeks.)
- Trauma-Related Guilt Inventory (TRGI)(Baseline and week 14.)
- Negative Core Beliefs Inventory (NCBI)(Baseline and week 14.)
- The World Health Organization Five Well-being index (WHO-5)(Baseline and week 14.)
- California Psychotherapy Alliance Scale - Patient version (CALPAS-P)(From baseline to post-treatment, up to 14 weeks.)