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

Abstract

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 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 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 Netherlands Trial Register NL6965, registered 25/04/2018.

A brief measure of guilt and shame: validation of the Guilt and Shame Questionnaire (GSQ-8)

“…In total, 209 individuals seeking treatment for childhood trauma-related posttraumatic stress disorder participated in this study within the scope of an international multicentre clinical trial (Wibbelink et al, 2021 ). Data were collected in five, three and two mental healthcare centres in the Netherlands, Germany, and Australia (Wibbelink et al, 2021 ).…”

“…In total, 209 individuals seeking treatment for childhood trauma-related posttraumatic stress disorder participated in this study within the scope of an international multicentre clinical trial (Wibbelink et al, 2021 ). Data were collected in five, three and two mental healthcare centres in the Netherlands, Germany, and Australia (Wibbelink et al, 2021 ). Participants were eligible if they (1) were between 18 and 70 years old; (2) had a primary diagnosis of PTSD as assessed by the Structural Clinical Interview for DSM-5-Clinician Version or Research Version (SCID-5-CV/RV); (3) had experienced the worst traumatic event before the age of 16; and (4) had been experiencing PTSD symptoms for longer than three months.…”

Blended delivery of imagery rescripting for childhood PTSD: A case study during the COVID-19 pandemic

“…The IREM-freq study design is registered in NTR7153 and approved by the ethics committee of the University Amsterdam. The design manuscript of the study was submitted recently ( Wibbelink et al, 2021 ). Larry was randomly allocated to the two times a week ImRs condition, 90 minutes per session with a maximum of 12 sessions.…”

“…Due to the pandemic, the face-to-face sessions had to be stopped, and treatment was continued online. Because of methodological considerations, the study participants that could not be treated vis-à-vis were excluded from the IREM-freq study (see Wibbelink et al, 2021 , and trial registration). Therefore, the case of Larry could be separately presented.…”

“…ImRs might be potentially more cost-effective than EMDR, because of lower training costs and shorter sessions (60 vs 90 minutes). It is also still not clear how session frequency impacts the effectiveness of PTSD treatments, whether treatment type moderates the frequency effect, and which treatment type and frequency works best for which patient ( Wibbelink et al, 2021 ). ImRs uses a different method compared to prolonged exposure and EMDR, therefore, ImRs might additionally work for patients who do not benefit from other PTSD treatments.…”