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 Pandemic: A Study Protocol
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design
2.2. Hypotheses
2.3. Participants
2.4. Inclusion Criteria
2.5. Exclusion Criteria
2.6. Study Settings
2.7. Interventions
- Trial-based cognitive therapy
- Mindfulness-based health promotion
- Positive psychotherapy
2.8. Outcomes
2.9. Instruments
- Diagnostic assessment
- Primary outcome
- Secondary outcome
- Mediator variables
2.10. Sample Size
2.11. Randomization and Sequence Generation
2.12. Implementation
2.13. Randomization and Concealment
2.14. Interventions Similarities and Differences
2.15. Statistical Methods
2.16. Ethical Aspects
3. Discussion
4. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Registration Number for Clinical Research
References
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Study Period | |||||||
---|---|---|---|---|---|---|---|
Enrolment | Allocation | Post-Allocation | Follow-Up | ||||
Timepoint | Screening | Baseline | 7 weeks | 14 weeks | 3 months | 6 months | 12 months |
Enrolment: | |||||||
Eligibility screen | X | ||||||
Informed consent | X | ||||||
Allocation | X | ||||||
Interventions: | |||||||
TBCT | |||||||
MBHP | |||||||
PPT | |||||||
Assessments: | |||||||
PCL-5 | X | ||||||
SCID-5 | X | ||||||
CAPS-5 | X | X | X | X | X | X | |
HADS | X | X | X | X | X | X | |
TRGI | X | X | X | X | X | X | |
NCBI | X | X | X | X | X | X | |
WHO-5 | X | X | X | X | X | X | |
CALPAS-P | X | X | X | ||||
SS interview | X |
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Duran, É.P.; Hemanny, C.; Vieira, R.; Nascimento, O.; Machado, L.; de Oliveira, I.R.; Demarzo, M. 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 Pandemic: A Study Protocol. Int. J. Environ. Res. Public Health 2022, 19, 819. https://doi.org/10.3390/ijerph19020819
Duran ÉP, Hemanny C, Vieira R, Nascimento O, Machado L, de Oliveira IR, Demarzo M. 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 Pandemic: A Study Protocol. International Journal of Environmental Research and Public Health. 2022; 19(2):819. https://doi.org/10.3390/ijerph19020819
Chicago/Turabian StyleDuran, Érica Panzani, Curt Hemanny, Renata Vieira, Orlando Nascimento, Leonardo Machado, Irismar Reis de Oliveira, and Marcelo Demarzo. 2022. "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 Pandemic: A Study Protocol" International Journal of Environmental Research and Public Health 19, no. 2: 819. https://doi.org/10.3390/ijerph19020819
APA StyleDuran, É. P., Hemanny, C., Vieira, R., Nascimento, O., Machado, L., de Oliveira, I. R., & Demarzo, M. (2022). 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 Pandemic: A Study Protocol. International Journal of Environmental Research and Public Health, 19(2), 819. https://doi.org/10.3390/ijerph19020819