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. 2023 Apr 19:33:101134.
doi: 10.1016/j.conctc.2023.101134. eCollection 2023 Jun.

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

W Lau  1 , K Chisholm  1 , M W Gallagher  2 , K Felmingham  3 , K Murray  1 , A Pearce  1 , N Doyle  1 , S Alexander  1 , H O'Brien  1 , A Putica  1 , J Khatri  4 , P Bockelmann  1 , F Hosseiny  5   6 , A Librado  5 , M Notarianni  5   6 , M L O'Donnell  1
Affiliations

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

W Lau et al. Contemp Clin Trials Commun. .

Abstract

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).

Keywords: Emotion regulation; PTSD; Posttraumatic stress disorder; Prolonged exposure; Randomized controlled trial; Transdiagnostic treatment; Unified protocol.

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Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
Planned participant flow through the study. UP: Unified Protocol: PE: Prolonged Exposure.
See this image and copyright information in PMC

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