Trauma-focused therapies for post-traumatic stress in psychosis: Study protocol for the RE.PROCESS randomized controlled trial
The first RCT to compare the effects of cognitive restructuring (CR), prolonged exposure (PE), and EMDR in individuals with psychosis & PTSD.
Article Abstract
“Introduction: Many people with psychotic disorders experience symptoms of post-traumatic stress disorder (PTSD). In recent years, several trauma-focused therapies (TFTs), including cognitive restructuring (CR), prolonged exposure (PE), and eye movement desensitization and reprocessing (EMDR) have been studied and found to be safe and effective in reducing PTSD symptoms in individuals with psychosis. However, studies were conducted in different countries, with varying inclusion criteria, therapy duration, control groups, and trial outcomes. RE.PROCESS will be the first study to compare the impact of CR, PE, and EMDR with a waiting list control condition within the same context.
Methods and analysis: This is the protocol of a pragmatic, single-blind, multicentre, superiority randomized controlled trial, in which CR, PE, and EMDR are compared to a waiting list control condition for TFT (WL) in a naturalistic treatment setting. Inclusion criteria are as follows: age ≥ 16 years; meeting full DSM-5 diagnostic criteria for PTSD on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), with a total CAPS score ≥ 23; and a psychotic disorder in the schizophrenia spectrum confirmed by the Structured Clinical Interview for DSM-5 (SCID-5). Participants (N=200) will be randomly allocated to 16 sessions of one of the TFTs or WL, in addition to receiving treatment as usual (TAU) for psychosis. The primary objective is to compare the effects of CR, PE, and EMDR to WL on researcher-rated severity of PTSD symptoms over time from baseline to 6-month follow-up. Secondary objectives are to examine these effects at the separate time-points (i.e., mid-treatment, post-treatment, and at 6-month follow-up) and to test the effects for clinician-rated presence of PTSD diagnosis, and self-rated severity of (complex) PTSD symptoms.
Discussion: This is the first RCT to directly compare the effects of CR, PE, and EMDR within the same context to TAU on PTSD symptoms in individuals with psychosis and PTSD. Secondary effects on clinical and functional outcomes will be investigated both directly after therapy and long term.”
—Description from publisher
Article Access
Open Access
Burger, S. R., van der Linden, T., Hardy, A., de Bont, P., van der Vleugel, B., Staring, A. B. P., de Roos, C., van Zelst, C., Gottlieb, J. D., Mueser, K. T., van Minnen, A., de Jongh, A., Marcelis, M., van der Gaag, M., & van den Berg, D. (2022). Trauma-focused therapies for post-traumatic stress in psychosis: Study protocol for the RE.PROCESS randomized controlled trial. BMC Trials, 23, 851. Open access: https://doi.org/10.1186/s13063-022-06808-6
Date
October 5, 2022
Creator(s)
Simone R. Burger, Tineke van der Linden, Amy Hardy
Contributor(s)
Paul de Bont, Berber van der Vleugel, Anton B. P. Staring, Carlijn de Roos, Catherine van Zelst, Jennifer D. Gottlieb, Kim T. Mueser, Agnes van Minnen, Ad de Jongh, Machteld Marcelis, Mark van der Gaag, David van den Berg
Topics
PTSD, Psychosis/Schizophrenia
Extent
13 pages
Publisher
Springer Nature
Rights
© The Author(s) 2022. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
APA Citation
Burger, S. R., van der Linden, T., Hardy, A., de Bont, P., van der Vleugel, B., Staring, A. B. P., de Roos, C., van Zelst, C., Gottlieb, J. D., Mueser, K. T., van Minnen, A., de Jongh, A., Marcelis, M., van der Gaag, M., & van den Berg, D. (2022). Trauma-focused therapies for post-traumatic stress in psychosis: Study protocol for the RE.PROCESS randomized controlled trial. BMC Trials, 23, 851. Open access: https://doi.org/10.1186/s13063-022-06808-6
Audience
EMDR Therapists, Other Mental Health Professionals
Language
English
Content Type
Article, Peer-Reviewed, RCT
Access Type
External Resource, Open Access
