The effect of twice-weekly versus once-weekly sessions of either imagery rescripting or eye movement desensitization and reprocessing for adults with PTSD from childhood trauma (IREM-Freq): a study protocol for an international randomized clinical trial.


Journal

Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253

Informations de publication

Date de publication:
27 Nov 2021
Historique:
received: 13 11 2020
accepted: 11 10 2021
entrez: 28 11 2021
pubmed: 29 11 2021
medline: 1 12 2021
Statut: epublish

Résumé

Trauma-focused treatments for posttraumatic stress disorder (PTSD) are commonly delivered either once or twice a week. Initial evidence suggests that session frequency affects treatment response, but very few trials have investigated the effect of session frequency. The present study's aim is to compare treatment outcomes of twice-weekly versus once-weekly sessions of two treatments for PTSD related to childhood trauma, imagery rescripting (ImRs) and eye movement desensitization and reprocessing (EMDR). We hypothesize that both treatments will be more effective when delivered twice than once a week. How session frequency impacts treatment response, whether treatment type moderates the frequency effect, and which treatment type and frequency works best for whom will also be investigated. The IREM-Freq trial is an international multicenter randomized clinical trial conducted in mental healthcare centers across Australia, Germany, and the Netherlands. We aim to recruit 220 participants, who will be randomized to one of four conditions: (1) EMDR once a week, (2) EMDR twice a week, (3) ImRs once a week, or (4) ImRs twice a week. Treatment consists of 12 sessions. Data are collected at baseline until one-year follow-up. The primary outcome measure is clinician-rated PTSD symptom severity. Secondary outcome measures include self-reported PTSD symptom severity, complex PTSD symptoms, trauma-related cognitions and emotions, depressive symptoms, dissociation, quality of life, and functioning. Process measures include memory, learning, therapeutic alliance, motivation, reluctance, and avoidance. Additional investigations will focus on predictors of treatment outcome and PTSD severity, change mechanisms of EMDR and ImRs, the role of emotions, cognitions, and memory, the optimization of treatment selection, learned helplessness, perspectives of patients and therapists, the network structure of PTSD symptoms, and sudden treatment gains. This study will extend our knowledge on trauma-focused treatments for PTSD related to childhood trauma and, more specifically, the importance of session frequency. More insight into the optimal session frequency could lead to improved treatment outcomes and less dropout, and in turn, to a reduction of healthcare costs. Moreover, the additional investigations will broaden our understanding of how the treatments work and variables that affect treatment outcome. Netherlands Trial Register NL6965, registered 25/04/2018.

Sections du résumé

BACKGROUND BACKGROUND
Trauma-focused treatments for posttraumatic stress disorder (PTSD) are commonly delivered either once or twice a week. Initial evidence suggests that session frequency affects treatment response, but very few trials have investigated the effect of session frequency. The present study's aim is to compare treatment outcomes of twice-weekly versus once-weekly sessions of two treatments for PTSD related to childhood trauma, imagery rescripting (ImRs) and eye movement desensitization and reprocessing (EMDR). We hypothesize that both treatments will be more effective when delivered twice than once a week. How session frequency impacts treatment response, whether treatment type moderates the frequency effect, and which treatment type and frequency works best for whom will also be investigated.
METHODS METHODS
The IREM-Freq trial is an international multicenter randomized clinical trial conducted in mental healthcare centers across Australia, Germany, and the Netherlands. We aim to recruit 220 participants, who will be randomized to one of four conditions: (1) EMDR once a week, (2) EMDR twice a week, (3) ImRs once a week, or (4) ImRs twice a week. Treatment consists of 12 sessions. Data are collected at baseline until one-year follow-up. The primary outcome measure is clinician-rated PTSD symptom severity. Secondary outcome measures include self-reported PTSD symptom severity, complex PTSD symptoms, trauma-related cognitions and emotions, depressive symptoms, dissociation, quality of life, and functioning. Process measures include memory, learning, therapeutic alliance, motivation, reluctance, and avoidance. Additional investigations will focus on predictors of treatment outcome and PTSD severity, change mechanisms of EMDR and ImRs, the role of emotions, cognitions, and memory, the optimization of treatment selection, learned helplessness, perspectives of patients and therapists, the network structure of PTSD symptoms, and sudden treatment gains.
DISCUSSION CONCLUSIONS
This study will extend our knowledge on trauma-focused treatments for PTSD related to childhood trauma and, more specifically, the importance of session frequency. More insight into the optimal session frequency could lead to improved treatment outcomes and less dropout, and in turn, to a reduction of healthcare costs. Moreover, the additional investigations will broaden our understanding of how the treatments work and variables that affect treatment outcome.
TRIAL REGISTRATION BACKGROUND
Netherlands Trial Register NL6965, registered 25/04/2018.

Identifiants

pubmed: 34838102
doi: 10.1186/s13063-021-05712-9
pii: 10.1186/s13063-021-05712-9
pmc: PMC8626728
doi:

Types de publication

Clinical Trial Protocol Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

848

Informations de copyright

© 2021. The Author(s).

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Auteurs

Carlijn J M Wibbelink (CJM)

Department of Clinical Psychology, University of Amsterdam, Nieuwe Achtergracht 129-B, 1018 WS, Amsterdam, the Netherlands. C.J.M.Wibbelink@uva.nl.

Christopher W Lee (CW)

Faculty of Health and Medical Sciences, University of Western Australia, 35 Stirling Highway, Crawley, Western Australia, 6009, Australia.

Nathan Bachrach (N)

GGZ Oost Brabant, RINO Zuid and Tilburg University, Kluisstraat 2, 5427 EM, Boekel, the Netherlands.

Sarah K Dominguez (SK)

School of Psychology and Exercise Science, Murdoch University and Sexual Assault Resource Centre, 90 South Street, Murdoch, Western Australia, 6150, Australia.

Thomas Ehring (T)

Department of Psychology, LMU Munich, Leopoldstr. 13, 80802, Munich, Germany.

Saskia M van Es (SM)

PsyQ Amsterdam, Parnassia Groep, Overschiestraat 57, 1062 HN, Amsterdam, the Netherlands.

Eva Fassbinder (E)

Department of Psychiatry and Psychotherapy, Christian-Albrechts-University Kiel, Niemannsweg 147, 24105, Kiel, Germany.
Department of Psychiatry and Psychotherapy, University of Lübeck, Ratzeburger Allee 160, 23538, Lübeck, Germany.

Sandra Köhne (S)

Department of Psychiatry and Psychotherapy, University of Lübeck, Ratzeburger Allee 160, 23538, Lübeck, Germany.

Magda Mascini (M)

GGZ Noord-Holland-Noord, Stationsplein 138, 1703 WC, Heerhugowaard, the Netherlands.

Marie-Louise Meewisse (ML)

Abate, Centre of Expertise in Anxiety and Trauma, Postweg 3, 1601 SX, Enkhuizen, the Netherlands.

Simone Menninga (S)

PsyQ Beverwijk, Parnassia Groep, Leeghwaterweg 1a, 1951 NA, Velsen-Noord, the Netherlands.

Nexhmedin Morina (N)

Institute of Psychology, University of Münster, Fliednerstr. 21, 48149, Muenster, Germany.

Sophie A Rameckers (SA)

Department of Clinical Psychology, University of Amsterdam, Nieuwe Achtergracht 129-B, 1018 WS, Amsterdam, the Netherlands.

Kathleen Thomaes (K)

Sinai Center, the Psychotrauma Expertise Center of Arkin and Amsterdam UMC, location VUmc, Department Psychiatry and Department of Anatomy and Neuroscience, Laan van de Helende Meesters 2, 1186 AM, Amstelveen, the Netherlands.

Carla J Walton (CJ)

Centre for Psychotherapy, Hunter New England Mental Health Service, NSW, Australia, PO Box 833, Newcastle, NSW, 2300, Australia.

Ingrid G Wigard (IG)

PsyQ Amsterdam, Parnassia Groep, Overschiestraat 57, 1062 HN, Amsterdam, the Netherlands.

Arnoud Arntz (A)

Department of Clinical Psychology, University of Amsterdam, Nieuwe Achtergracht 129-B, 1018 WS, Amsterdam, the Netherlands.

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