Evidence map›Paper›PMID 36199107›Full record

ArticleTrials2022

Trauma-focused therapies for post-traumatic stress in psychosis: study protocol for the RE.PROCESS randomized controlled trial.

Simone R Burger, Tineke van der Linden, Amy Hardy, Paul de Bont, Berber van der Vleugel, Anton B P Staring, Carlijn de Roos, Catherine van Zelst, Jennifer D Gottlieb, Kim T Mueser and 5 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
2.9field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 15 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 9 institutions in 3 countries.

Simone R Burger *Department of Clinical Psychology, VU University and Amsterdam Public Health Research Institute, Room MF-B543, Van der Boechorstraat 7, Amsterdam, 1081 BT, the Netherlands. s.r.burger@vu.nl.ORCID http://orcid.org/0000-0001-8927-0338
Tineke van der Linden *Department of Clinical Psychology, VU University and Amsterdam Public Health Research Institute, Room MF-B543, Van der Boechorstraat 7, Amsterdam, 1081 BT, the Netherlands.
Amy HardyInstitute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
Paul de BontGGZ Oost-Brabant Mental Health Institute, Boekel, the Netherlands.
Berber van der VleugelGGZ Noord-Holland-Noord Mental Health Institute, Alkmaar, the Netherlands.
Anton B P StaringAltrecht Mental Health Institute, Utrecht, the Netherlands.
Carlijn de RoosAcademic Centre for Child and Adolescent Psychiatry Level, Amsterdam University Medical Centre (location AMC), Amsterdam, The Netherlands.
Catherine van ZelstDepartment of Psychosis Research and Innovation, Parnassia Psychiatric Institute, The Hague, the Netherlands.
Jennifer D GottliebCambridge Health Alliance & Harvard Medical School Department of Psychiatry, Cambridge, MA, USA.
Kim T MueserBoston University, Boston, USA.
Agnes van MinnenBehavourial Science Institute, Radboud Universiteit Nijmegen, Nijmegen, the Netherlands.
Ad de JonghPSYTREC Mental Health Institute, Bilthoven, the Netherlands.
Machteld MarcelisDepartment of Research and Innovation, GGzE Mental Health Institute, Eindhoven, the Netherlands.
Mark van der GaagDepartment of Clinical Psychology, VU University and Amsterdam Public Health Research Institute, Room MF-B543, Van der Boechorstraat 7, Amsterdam, 1081 BT, the Netherlands.
David van den BergDepartment of Clinical Psychology, VU University and Amsterdam Public Health Research Institute, Room MF-B543, Van der Boechorstraat 7, Amsterdam, 1081 BT, the Netherlands.
Parnassia Groep · NLAltrecht GGZ · NLCambridge Health Alliance · USGGZ Noord-Holland-Noord · NLGGZ Oost Brabant · NLKing's College London · GBMaastricht University · NLQueen's University Belfast · GBRadboud University Nijmegen · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionMany 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.

trial registrationISRCTN ISRCTN56150327 . Registered 18 June 2019.

Indexed as

Eye Movement Desensitization ReprocessingPsychotic DisordersStress Disorders, Post-TraumaticAdolescentEquivalence Trials as TopicHumansMulticenter Studies as TopicPragmatic Clinical Trials as TopicPsychotherapyRandomized Controlled Trials as TopicSingle-Blind MethodTreatment OutcomeCognitive restructuringEMDR therapyProlonged exposurePsychosisPTSDTraumaTrauma-focused treatment

Identifiers

PMID36199107
PMCPMC9532824
OpenAlexW4301586404

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.