Phase-based treatment versus immediate trauma-focused treatment in patients with childhood trauma-related posttraumatic stress disorder: study protocol for a randomized controlled trial

Abstract

BackgroundThe treatment of posttraumatic stress disorder (PTSD) related to a history of sexual and/or physical abuse in childhood is the subject of international debate, with some favouring a phase-based approach as their preferred treatment, while others argue for immediate trauma-focused treatment. A history of (chronic) traumatisation during childhood has been linked to the development of distinct symptoms that are often labelled as symptoms of complex PTSD. Many therapists associate the presence of symptoms of complex PTSD with a less favourable treatment prognosis. The purpose of this study is to determine whether a phase-based approach is more effective than stand-alone trauma-focused therapy in individuals with PTSD and possible symptoms of complex PTSD resulting from a history of repeated sexual and/or physical abuse in childhood. An additional aim is to investigate moderators, predictors of treatment (non) response and drop-out.MethodThe sample consists of patients between 18 and 65 years old with a diagnosis of PTSD who report a history of repeated sexual and/or physical abuse in childhood (N = 122). Patients will be blindly allocated to either 16 sessions of eye movement desensitization and reprocessing (EMDR) therapy preceded by a stabilization phase (eight sessions of Skills Training in Affect and Interpersonal Regulation (STAIR)) or only 16 sessions of EMDR therapy. Assessments are carried out pre-treatment, after every eighth session, post-treatment, and at 3 and 6 months follow up. The main parameter will be the severity of PTSD symptoms (PTSD Symptoms Scale-Self Report). Secondary outcome variables are the presence of a PTSD diagnosis (Clinician-Administered PTSD Scale for DSM-5), severity of complex PTSD symptoms (Structured Interview for Disorders of Extreme Stress-Revised and symptoms-specific questionnaires), changes in symptoms of general psychopathology (Brief Symptom Inventory), and quality of life (Euroqol-5D). Health care consumption and productivity loss in patients will also be indexed.DiscussionThe study results may help to inform the ongoing debate about whether a phase-based approach has added value over immediate trauma-focused therapy in patients suffering from PTSD due to childhood abuse. Furthermore, the results will contribute to knowledge about the safety, efficacy, and cost-effectiveness of treatments in this target group.Trial registrationNederlands Trialregister, NTR5991. Registered on 23 august 2016. http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5991Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2508-8) contains supplementary material, which is available to authorized users.

Phase-based treatment versus immediate trauma-focused treatment for post-traumatic stress disorder due to childhood abuse: randomised clinical trial

“…The study is a single-blind RCT with two arms (EMDR therapy versus EMDR therapy preceded by STAIR) with measurements at pre-treatment, every eight sessions, post-treatment and at 3- and 6-month follow-up. The design paper for this trial 8 is available at . This also includes a CONSORT checklist.…”

“…If they agreed to participate and signed the informed consent form, they were assessed for inclusion ( n = 151). After inclusion, participants were randomly assigned to one of the two treatment conditions (the exact randomisation procedure is described in the design paper 8 ).…”

Research and recovery: Can patient participation in research promote recovery for people with complex post‐traumatic stress disorder, CPTSD?

“…Many clinicians advocate a three-phase approach for psychological treatment which was originally formulated by Judith Herman in 1992, 18 although this has recently been contested. 19,20 Herman described an initial stabilization phase, a trauma-focused stage and a community re-integration stage. From this perspective, participating in research could be seen as community integration during which relationships with others are rebuilt.…”

“…Many clinicians advocate a three‐phase approach for psychological treatment which was originally formulated by Judith Herman in 1992,18 although this has recently been contested 19,20. Herman described an initial stabilization phase, a trauma‐focused stage and a community re‐integration stage.…”

The Tern Programme Study protocol for an implementation trial of a flexible, long-term psychosocial intervention for complex posttraumatic stress in young people

“…Expert consensus has recommended that CT interventions follow a ‘phased’ structure with client safety and self-regulation skills prioritized before the use of exposure-based techniques for addressing traumatic memory (Cloitre et al, 2011 ). However, this recommendation has been criticized due to lack of evidence, which has led to a new area of investigation regarding the true benefits of delaying exposure methods in the treatment of CT (Cloitre, 2015 ; de Jongh et al, 2016 ; van Vliet, Huntjens, van Dijk, & de Jongh, 2018 ). Further studies are required to clarify the circumstances in which phased interventions are/are not of benefit – particularly for young people.…”