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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
January 1, 1970
Érica Panzani Duran et al. (7 authors)
Clinical Trial ProtocolJournal ArticleResearch Support, Non-U.S. Gov'tHuman StudyClinical
Study Details

Study Goal

The researchers aimed to compare the efficacy of mindfulness-based health promotion (MBHP) with other psychotherapies in reducing PTSD symptoms and improving mental health outcomes during the COVID-19 pandemic.

Results Summary

The study expects PTSD symptoms to be reduced after MBHP, with no significant statistical difference anticipated among the three therapies (TBCT, MBHP, PPT). Secondary outcomes like anxiety, depression, and well-being were also targeted for improvement.

Population

Patients with post-traumatic stress disorder (PTSD) during the COVID-19 pandemic.

Effective Dosage

Not specified (individual, weekly online sessions).

Duration

14 sessions (weekly).

Interactions

None mentioned

Extracted Claims (21)
InterventionDirectionEndpointPopulationDosageImpactClaim #
trial-based cognitive therapy (TBCT)
decrease
symptoms of PTSD
patients with PTSD
-
to reduce
#1
mindfulness-based health promotion (MBHP)
decrease
symptoms of PTSD
patients with PTSD
-
to reduce
#2
positive psychotherapy (PPT)
decrease
symptoms of PTSD
patients with PTSD
-
to reduce
#3
trial-based cognitive therapy (TBCT)
decrease
anxiety
patients with PTSD
-
to compare the efficacy
#4
mindfulness-based health promotion (MBHP)
decrease
anxiety
patients with PTSD
-
to compare the efficacy
#5
positive psychotherapy (PPT)
decrease
anxiety
patients with PTSD
-
to compare the efficacy
#6
trial-based cognitive therapy (TBCT)
decrease
depression
patients with PTSD
-
to compare the efficacy
#7
mindfulness-based health promotion (MBHP)
decrease
depression
patients with PTSD
-
to compare the efficacy
#8
positive psychotherapy (PPT)
decrease
depression
patients with PTSD
-
to compare the efficacy
#9
trial-based cognitive therapy (TBCT)
decrease
guilt
patients with PTSD
-
to compare the efficacy
#10
mindfulness-based health promotion (MBHP)
decrease
guilt
patients with PTSD
-
to compare the efficacy
#11
positive psychotherapy (PPT)
decrease
guilt
patients with PTSD
-
to compare the efficacy
#12
trial-based cognitive therapy (TBCT)
increase
well-being
patients with PTSD
-
to compare the efficacy
#13
mindfulness-based health promotion (MBHP)
increase
well-being
patients with PTSD
-
to compare the efficacy
#14
positive psychotherapy (PPT)
increase
well-being
patients with PTSD
-
to compare the efficacy
#15
trial-based cognitive therapy (TBCT)
decrease
PTSD symptoms
patients with PTSD
-
are expected to be reduced
#16
mindfulness-based health promotion (MBHP)
decrease
PTSD symptoms
patients with PTSD
-
are expected to be reduced
#17
positive psychotherapy (PPT)
decrease
PTSD symptoms
patients with PTSD
-
are expected to be reduced
#18
trial-based cognitive therapy (TBCT)
no change
efficacy
patients with PTSD
-
No statistical difference is expected to be found
#19
mindfulness-based health promotion (MBHP)
no change
efficacy
patients with PTSD
-
No statistical difference is expected to be found
#20
positive psychotherapy (PPT)
no change
efficacy
patients with PTSD
-
No statistical difference is expected to be found
#21
Abstract

BACKGROUND: Research suggests the use of different forms of therapy as a way of decreasing dropout rates in the treatment of post-traumatic stress disorder (PTSD). The psychotherapies to be assessed in this study are trial-based cognitive therapy (TBCT), mindfulness-based health promotion (MBHP) and positive psychotherapy (PPT). OBJECTIVES: (1) to assess the online efficacy of TBCT compared to MBHP and PPT to reduce the symptoms of PTSD in the context of the Coronavirus Disease 2019 (COVID-19) pandemic; (2) to compare the efficacy of these psychotherapies in improving anxiety, depression, guilt and in promoting well-being; and (3) to describe how professionals perceive online treatment. METHODS: A randomized, multicenter, single-blind clinical trial will be conducted, with three separate arms. An estimated sample of 135 patients will receive either TBCT, MBHP or PPT and will be treated through online, individual, weekly visits, totaling 14 sessions. The primary outcome will be CAPS-5 and secondary outcomes will be HADS and WHO-5. The variables used to mediate these outcomes will be the Trauma-Related Guilt Inventory (TRGI), Negative Core Beliefs Inventory (NCBI) and the California Psychotherapy Alliance Scale (CALPAS-P). EXPECTED RESULTS: PTSD symptoms are expected to be reduced after TBCT, MBHP and PPT. No statistical difference is expected to be found among the three. DISCUSSION: The present study will evaluate and contribute towards the development of new psychotherapeutic options for patients with PTSD. The results of this study will allow the dissemination of new effective and adaptable interventions for patients with PTSD.

Medical Subject Headings (MeSH)
COVID-19Cognitive Behavioral TherapyHealth PromotionHumansMindfulnessMulticenter Studies as TopicPandemicsPsychotherapyRandomized Controlled Trials as TopicSARS-CoV-2Single-Blind MethodStress Disorders, Post-TraumaticTreatment Outcome
Study Links
Quality Scores
SafetyNot Assessed
Efficacy75/10
Quality85/10
Citation Metrics
Total Citations4
Citations/Year1.3
Relative Citation Ratio0.87
NIH Percentile45%
Research Impact Scores
APT Score0.50
Weight Score1.61
Normalized Score0.67
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