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Comparing the unified protocol for transdiagnostic treatment of emotional disorders to prolonged exposure for the treatment of PTSD: Design of a non-inferiority randomized controlled trial

BACKGROUND: Prolonged Exposure (PE), a trauma-focused therapy, is one of the most efficacious treatments available for PTSD. However, many people with PTSD do not lose their diagnosis following delivery of PE. The Unified Protocol (UP) for Transdiagnostic Treatment of Emotional Disorders is a non-tr...

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Autores principales: Lau, W., Chisholm, K., Gallagher, M.W., Felmingham, K., Murray, K., Pearce, A., Doyle, N., Alexander, S., O'Brien, H., Putica, A., Khatri, J., Bockelmann, P., Hosseiny, F., Librado, A., Notarianni, M., O'Donnell, M.L.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10205430/
https://www.ncbi.nlm.nih.gov/pubmed/37228903
http://dx.doi.org/10.1016/j.conctc.2023.101134
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author Lau, W.
Chisholm, K.
Gallagher, M.W.
Felmingham, K.
Murray, K.
Pearce, A.
Doyle, N.
Alexander, S.
O'Brien, H.
Putica, A.
Khatri, J.
Bockelmann, P.
Hosseiny, F.
Librado, A.
Notarianni, M.
O'Donnell, M.L.
author_facet Lau, W.
Chisholm, K.
Gallagher, M.W.
Felmingham, K.
Murray, K.
Pearce, A.
Doyle, N.
Alexander, S.
O'Brien, H.
Putica, A.
Khatri, J.
Bockelmann, P.
Hosseiny, F.
Librado, A.
Notarianni, M.
O'Donnell, M.L.
author_sort Lau, W.
collection PubMed
description BACKGROUND: Prolonged Exposure (PE), a trauma-focused therapy, is one of the most efficacious treatments available for PTSD. However, many people with PTSD do not lose their diagnosis following delivery of PE. The Unified Protocol (UP) for Transdiagnostic Treatment of Emotional Disorders is a non-trauma focused treatment that may offer an alternative treatment for PTSD. METHODS: This paper describes the study protocol for IMPACT, an assessor-blinded randomized controlled trial that examines the non-inferiority of UP relative to PE for participants who meet DSM-5 criteria for current PTSD. One hundred and twenty adult participants with PTSD will be randomized to receive either 10 × 90-min sessions of UP or PE with a trained provider. The primary outcome is severity of PTSD symptoms assessed by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) at post-treatment. DISCUSSION: While evidence-based treatments are available for PTSD, high levels of treatment dropout and non-response require new approaches to be tested. The UP is based on emotion regulation theory and is effective in treating anxiety and depressive disorders, however, there has been limited application to PTSD. This is the first rigorous study comparing UP to PE in a non-inferiority randomized controlled trial and may help improve clinical outcomes for those with PTSD. TRIAL REGISTRATION: This trial was prospectively registered with the Australian New Zealand Clinical Trials Registry, Trial ID (ACTRN12619000543189).
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spelling pubmed-102054302023-05-24 Comparing the unified protocol for transdiagnostic treatment of emotional disorders to prolonged exposure for the treatment of PTSD: Design of a non-inferiority randomized controlled trial Lau, W. Chisholm, K. Gallagher, M.W. Felmingham, K. Murray, K. Pearce, A. Doyle, N. Alexander, S. O'Brien, H. Putica, A. Khatri, J. Bockelmann, P. Hosseiny, F. Librado, A. Notarianni, M. O'Donnell, M.L. Contemp Clin Trials Commun Article BACKGROUND: Prolonged Exposure (PE), a trauma-focused therapy, is one of the most efficacious treatments available for PTSD. However, many people with PTSD do not lose their diagnosis following delivery of PE. The Unified Protocol (UP) for Transdiagnostic Treatment of Emotional Disorders is a non-trauma focused treatment that may offer an alternative treatment for PTSD. METHODS: This paper describes the study protocol for IMPACT, an assessor-blinded randomized controlled trial that examines the non-inferiority of UP relative to PE for participants who meet DSM-5 criteria for current PTSD. One hundred and twenty adult participants with PTSD will be randomized to receive either 10 × 90-min sessions of UP or PE with a trained provider. The primary outcome is severity of PTSD symptoms assessed by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) at post-treatment. DISCUSSION: While evidence-based treatments are available for PTSD, high levels of treatment dropout and non-response require new approaches to be tested. The UP is based on emotion regulation theory and is effective in treating anxiety and depressive disorders, however, there has been limited application to PTSD. This is the first rigorous study comparing UP to PE in a non-inferiority randomized controlled trial and may help improve clinical outcomes for those with PTSD. TRIAL REGISTRATION: This trial was prospectively registered with the Australian New Zealand Clinical Trials Registry, Trial ID (ACTRN12619000543189). Elsevier 2023-04-19 /pmc/articles/PMC10205430/ /pubmed/37228903 http://dx.doi.org/10.1016/j.conctc.2023.101134 Text en © 2023 Published by Elsevier Inc. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Article
Lau, W.
Chisholm, K.
Gallagher, M.W.
Felmingham, K.
Murray, K.
Pearce, A.
Doyle, N.
Alexander, S.
O'Brien, H.
Putica, A.
Khatri, J.
Bockelmann, P.
Hosseiny, F.
Librado, A.
Notarianni, M.
O'Donnell, M.L.
Comparing the unified protocol for transdiagnostic treatment of emotional disorders to prolonged exposure for the treatment of PTSD: Design of a non-inferiority randomized controlled trial
title Comparing the unified protocol for transdiagnostic treatment of emotional disorders to prolonged exposure for the treatment of PTSD: Design of a non-inferiority randomized controlled trial
title_full Comparing the unified protocol for transdiagnostic treatment of emotional disorders to prolonged exposure for the treatment of PTSD: Design of a non-inferiority randomized controlled trial
title_fullStr Comparing the unified protocol for transdiagnostic treatment of emotional disorders to prolonged exposure for the treatment of PTSD: Design of a non-inferiority randomized controlled trial
title_full_unstemmed Comparing the unified protocol for transdiagnostic treatment of emotional disorders to prolonged exposure for the treatment of PTSD: Design of a non-inferiority randomized controlled trial
title_short Comparing the unified protocol for transdiagnostic treatment of emotional disorders to prolonged exposure for the treatment of PTSD: Design of a non-inferiority randomized controlled trial
title_sort comparing the unified protocol for transdiagnostic treatment of emotional disorders to prolonged exposure for the treatment of ptsd: design of a non-inferiority randomized controlled trial
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10205430/
https://www.ncbi.nlm.nih.gov/pubmed/37228903
http://dx.doi.org/10.1016/j.conctc.2023.101134
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