Clinical trial NCT04852770: Efficacy of TBCT, MBHP and PPT for PTSD During the Covid-19 Pandemics
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Covid19
Keywords: Cognitive-Behavior Therapy
Trial-Based Cognitive Therapy
Mindfulness Based Health Promotion
Positive Psychotherapy
PTSD
Covid 19
Randomized clinical trial
Lead sponsor: Fundação Bahiana de Infectologia
Sponsor class: OTHER
Collaborators: name: Mente Aberta
First posted: 2021-04-21
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 to COVID-19 \[e.g., health professionals, people who tested positive for Covid-19 (or their relative or close friends), or those who quarantined, isolated or socially distanced themselves\];
* Participants should be able to read, write and follow instructions, and have access to the a stable internet connexion.

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).

Primary outcomes:
measure: The Clinician-Administered PTSD Scale (CAPS-5)
timeFrame: Baseline and week 14.
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline and week 14.
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: From baseline to post-treatment, up 14 weeks.
measure: Trauma-Related Guilt Inventory (TRGI)
timeFrame: Baseline and week 14.
measure: Negative Core Beliefs Inventory (NCBI)
timeFrame: Baseline and week 14.
measure: The World Health Organization Five Well-being index (WHO-5)
timeFrame: Baseline and week 14.
measure: California Psychotherapy Alliance Scale - Patient version (CALPAS-P)
timeFrame: From baseline to post-treatment, up to 14 weeks.
Other outcomes:
measure: Structured Clinical Interview for DSM-5 - SCID
timeFrame: Baseline
measure: Posttraumatic stress disorder checklist for DSM-5 (PCL-5)
timeFrame: Baseline.
measure: The Clinician-Administered PTSD Scale (CAPS-5)
timeFrame: Week 7.
measure: The Clinician-Administered PTSD Scale (CAPS-5)
timeFrame: 6 months.
measure: The Clinician-Administered PTSD Scale (CAPS-5)
timeFrame: 12 months.
measure: The Clinician-Administered PTSD Scale (CAPS-5)
timeFrame: 18 months.
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Week 7.
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 6 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 12 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 18 months
measure: Trauma-Related Guilt Inventory (TRGI)
timeFrame: Week 7.
measure: Trauma-Related Guilt Inventory (TRGI)
timeFrame: 6 months.
measure: Trauma-Related Guilt Inventory (TRGI)
timeFrame: 12 months.
measure: Trauma-Related Guilt Inventory (TRGI)
timeFrame: 18 months.
measure: Negative Core Beliefs Inventory (NCBI)
timeFrame: Week 7.
measure: Negative Core Beliefs Inventory (NCBI)
timeFrame: 6 months.
measure: Negative Core Beliefs Inventory (NCBI)
timeFrame: 12 months.
measure: Negative Core Beliefs Inventory (NCBI)
timeFrame: 18 months.
measure: The World Health Organization Five Well-being index (WHO-5)
timeFrame: Week 7.
measure: The World Health Organization Five Well-being index (WHO-5)
timeFrame: 6 months
measure: The World Health Organization Five Well-being index (WHO-5)
timeFrame: 12 months
measure: The World Health Organization Five Well-being index (WHO-5)
timeFrame: 18 months
measure: Semi-structured interview regarding online psychotherapy and pandemics.
timeFrame: Week 14.
Locations:
city: Salvador
country: Brazil
facility: Universidade Federal da Bahia
state: Bahia
city: Recife
country: Brazil
facility: Universidade Federal de Pernambuco
state: Pernambuco
city: São Paulo
country: Brazil
facility: Universidade Federal de São Paulo
Study officials:
affiliation: Federal University of Bahia
name: Irismar Reis de Oliveira, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Neufeld CB, Palma PC, Caetano KAS, Brust-Renck PG, Curtiss J, Hofmann SG. A randomized clinical trial of group and individual Cognitive-Behavioral Therapy approaches for Social Anxiety Disorder. Int J Clin Health Psychol. 2020 Jan-Apr;20(1):29-37. doi: 10.1016/j.ijchp.2019.11.004. Epub 2019 Dec 24.
citation: Powell VB, Oliveira OH, Seixas C, Almeida C, Grangeon MC, Caldas M, Bonfim TD, Castro M, Galvao-de Almeida A, Moraes Rde O, Sudak D, de-Oliveira IR. Changing core beliefs with trial-based cognitive therapy may improve quality of life in social phobia: a randomized study. Braz J Psychiatry. 2013 Jul-Sep;35(3):243-7. doi: 10.1590/1516-4446-2012-0863.
citation: Oliveira IR. Trial-Based Thought Record (TBTR): preliminary data on a strategy to deal with core beliefs by combining sentence reversion and the use of analogy with a judicial process. Braz J Psychiatry. 2008 Mar;30(1):12-8. doi: 10.1590/s1516-44462008000100003.
citation: de Oliveira IR, Powell VB, Wenzel A, Caldas M, Seixas C, Almeida C, Bonfim T, Grangeon MC, Castro M, Galvao A, de Oliveira Moraes R, Sudak D. Efficacy of the trial-based thought record, a new cognitive therapy strategy designed to change core beliefs, in social phobia. J Clin Pharm Ther. 2012 Jun;37(3):328-34. doi: 10.1111/j.1365-2710.2011.01299.x. Epub 2011 Sep 28.
citation: Hemanny C, Carvalho C, Maia N, Reis D, Botelho AC, Bonavides D, Seixas C, de Oliveira IR. Efficacy of trial-based cognitive therapy, behavioral activation and treatment as usual in the treatment of major depressive disorder: preliminary findings from a randomized clinical trial. CNS Spectr. 2020 Aug;25(4):535-544. doi: 10.1017/S1092852919001457. Epub 2019 Nov 26.
citation: de Oliveira IR, Hemmany C, Powell VB, Bonfim TD, Duran EP, Novais N, Velasquez M, Di Sarno E, Alves GL, Cesnik JA; Brazilian TBTR Study Group. Trial-based psychotherapy and the efficacy of trial-based thought record in changing unhelpful core beliefs and reducing self-criticism. CNS Spectr. 2012 Mar;17(1):16-23. doi: 10.1017/S1092852912000399.
citation: Duran EP, Corchs F, Vianna A, Araujo AC, Del Real N, Silva C, Ferreira AP, De Vitto Francez P, Godoi C, Silveira H, Matsumoto L, Gebara CM, de Barros Neto TP, Chilvarquer R, de Siqueira LL, Bernik M, Neto FL. A randomized clinical trial to assess the efficacy of trial-based cognitive therapy compared to prolonged exposure for post-traumatic stress disorder: preliminary findings. CNS Spectr. 2021 Aug;26(4):427-434. doi: 10.1017/S1092852920001455. Epub 2020 May 26.
citation: Seligman MEP. Positive Psychology: A Personal History. Annu Rev Clin Psychol. 2019 May 7;15:1-23. doi: 10.1146/annurev-clinpsy-050718-095653. Epub 2018 Dec 10.
citation: Duckworth AL, Steen TA, Seligman ME. Positive psychology in clinical practice. Annu Rev Clin Psychol. 2005;1:629-51. doi: 10.1146/annurev.clinpsy.1.102803.144154.
citation: Mongrain M, Anselmo-Matthews T. Do positive psychology exercises work? A replication of Seligman et al. (2005). J Clin Psychol. 2012 Apr;68(4):382-9. doi: 10.1002/jclp.21839.
citation: Bovin MJ, Marx BP, Weathers FW, Gallagher MW, Rodriguez P, Schnurr PP, Keane TM. Psychometric properties of the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (PCL-5) in veterans. Psychol Assess. 2016 Nov;28(11):1379-1391. doi: 10.1037/pas0000254. Epub 2015 Dec 14.
citation: Trombka M, Demarzo M, Bacas DC, Antonio SB, Cicuto K, Salvo V, Claudino FCA, Ribeiro L, Christopher M, Garcia-Campayo J, Rocha NS. Study protocol of a multicenter randomized controlled trial of mindfulness training to reduce burnout and promote quality of life in police officers: the POLICE study. BMC Psychiatry. 2018 May 25;18(1):151. doi: 10.1186/s12888-018-1726-7.
citation: de Oliveira IR. Kafka's trial dilemma: proposal of a practical solution to Joseph K.'s unknown accusation. Med Hypotheses. 2011 Jul;77(1):5-6. doi: 10.1016/j.mehy.2011.03.010. Epub 2011 Mar 31.
citation: de Souza CM, Hidalgo MP. World Health Organization 5-item well-being index: validation of the Brazilian Portuguese version. Eur Arch Psychiatry Clin Neurosci. 2012 Apr;262(3):239-44. doi: 10.1007/s00406-011-0255-x. Epub 2011 Sep 7.