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

For posttraumatic stress disorder (PTSD), international expert consensus guidelines recommend the use of evidence-based, trauma-focused psychological treatments, particularly cognitive behavioural therapy (i.e., prolonged exposure) and eye movement desensitization and reprocessing (EMDR) therapy [1, 2]. For PTSD following childhood abuse, the application of trauma-focused treatments is generally associated with reductions in PTSD symptom severity and comorbid symptoms of depression, anxiety, and dissociation [3‐7].

Childhood physical and/or sexual abuse is considered to be one of the traumatic stressors associated with the development of complex PTSD [8]. The term complex PTSD was first launched by Herman [9] and is assumed to develop following the experience of severe, prolonged, and/or repeated interpersonal trauma. Complex PTSD is diagnosed when, in addition to meeting criteria for PTSD, trauma survivors exhibit disturbances in three domains of self-organization - affect regulation, self-concept, and interpersonal functioning [10] - and is currently being considered for inclusion as a separate diagnostic entity in International Classification of Diseases 11 (ICD-11) [11].

It has been argued that individuals with a history of childhood abuse who suffer from symptoms of complex PTSD may be insufficiently stable to tolerate evidence-based immediate trauma-focused treatment [8, 12]. In 2011 the International Society for Traumatic Stress Studies (ISTSS) Complex Trauma Task Force published the results of a survey meant to obtain expert opinions about the treatment of patients with symptoms of complex PTSD [13] showing that 85% of the experts reported that they would use a phase-based approach as their first line of treatment. Based upon these results, a phase-based treatment has been recommended for these patients [8], in which trauma-focused treatment (phase II) is preceded by a stabilization phase (phase I) aimed at ensuring the individual’s safety, reducing self-regulatory problems, and improving emotional, social, and other psychological skills. This phase-based approach is then completed with a reintegration phase (phase III), aimed at consolidating treatment gains and helping the person to adapt to his or her present life circumstances [8]. In clinical practice, the phase I treatment for PTSD with symptoms of complex PTSD varies from eight weekly sessions (i.e., the programme Skills Training in Affective and Interpersonal Regulation (STAIR)) [14] up to programme with a much longer duration [15, 16]. In the guidelines of the ISTSS the majority of the experts considered 6 months as a reasonable length for phase I [8].

Until now, the safety and efficacy of the phase-based treatment approach for treating complex PTSD has been addressed in two studies [12, 14]. The first study used a randomized controlled trial (RCT) to compare the efficacy of STAIR (a phase I treatment) followed by prolonged exposure versus a waiting-list condition in a sample of female patients that suffer from PTSD as a result of childhood physical and/or sexual abuse [14]. The STAIR/exposure condition resulted in significant symptom reductions (i.e., PTSD severity, depression, general anxiety, dissociation), plus significant improvements in mood and anger regulation skills. In the STAIR phase, depression, anxiety, anger expression, and negative mood regulation improved significantly. There were no improvements in PTSD symptoms, dissociation, and alexithymia. The prolonged Exposure (PE) phase showed reductions in PTSD symptoms, dissociation, and alexithymia, and further improvements in depression and anxiety. No improvements were found in negative mood regulation and in anger expression in the PE phase. The results of this study suggest that the combination of STAIR/exposure is feasible and leads to a decrease in PTSD and a broad range of other symptoms associated with complex PTSD. One limitation of this study, however, was the relatively high drop-out rate in the STAIR/exposure condition (29% compared to 11% in the waiting list control group). Also, effect sizes pointed to the phase of exposure treatment conferring the bulk of the therapeutic benefits. Hence, although this study supports the effectiveness of a STAIR/exposure combination, the results do not provide univocal support for the contention that a phase-based treatment is superior to immediate trauma-focused treatment for individuals suffering from severe PTSD and symptoms of complex PTSD (see also [17]). Clearly, there was a need for direct comparison between a phase-based and an immediate trauma-focused treatment condition. Accordingly, in a second study, Cloitre and colleagues evaluated the efficacy of a phase-based treatment (STAIR/exposure) versus supportive counselling followed by prolonged exposure (support/ exposure) and versus STAIR followed by supportive counselling (STAIR/support) [12]. Women with PTSD related to childhood sexual and/or physical abuse were assigned to one of the three treatment conditions. The application of STAIR/exposure was found to be associated with greater benefits compared to the support/exposure condition in terms of self-reported reduction in PTSD symptom severity, interpersonal problems, and emotion regulation, but only at follow up (both 3 and 6 months). Immediately after treatment, all three experimental treatment conditions resulted in a substantial proportion of patients being PTSD negative (i.e., no significant differences were found between the three conditions). However, the lack of a treatment condition in which patients were directly exposed to their traumatic memories precludes drawing any firm conclusions about the relative benefits of a phase-based treatment approach over an immediate trauma-focused approach for patients suffering from PTSD related to childhood abuse (see De Jongh et al.) [18]. In other words, the core question is still whether the addition of a stabilization phase is a necessary condition for, and/or has added value over, immediate trauma-focused treatment. And if so, it is important to know which of the two treatment approaches works best for whom. The present study aims to address these questions.

There is debate about the treatment of PTSD related to physical and/or sexual abuse during childhood. A history of (chronic) traumatisation during childhood has been linked to the development of distinct symptoms, such as problems in affect regulation, negative self-concept, and interpersonal problems, which are symptoms that are categorized under the name of complex PTSD [10].

Many experts in the trauma field consider a phase-based approach as the preferred treatment for individuals suffering from the consequences of (repeated) early childhood interpersonal trauma, with symptoms of complex PTSD [8, 12, 61]. Proponents of such a treatment trajectory argue that with the addition of a stabilization phase prior to a trauma-focused treatment, these individuals are more likely to profit from, and less likely to drop out of treatment. Stated differently: “without stabilization, operating at least at an implicit relational level, no trauma-focused intervention can have a durably positive outcome in the treatment of Complex PTSD” [62]. Conversely, proponents of the application of immediate evidence-based treatments for this target population argue that a stabilization phase could delay or restrict access to trauma-focused treatments, thereby preventing immediate benefit from those treatments [18]. Because of this controversy, the results of the present study may deliver a pivotal contribution to the field, and the worldwide debate about the treatment of individuals suffering from PTSD due to prolonged or repeated childhood abuse, which may lead to the development of more effective, tailor-made treatments for this group of patients.

An improvement in study design relative to previous studies is that the present study specifically focuses on the added value of stabilization. Assessing the two groups after the same amount of treatment sessions (after 8 or 16 sessions) may provide answers to the question as to which of the two conditions works best and in what phase of treatment. Comparing the two conditions post-treatment makes it possible to answer the question whether STAIR has an added value over EMDR only. As some previous studies found that treatment gains emerged only months after treatment has ended [12], the follow-up assessments are pivotal. To ensure that patients engaging in this study represent a group with severe psychopathology, our inclusion and exclusion criteria state that patients must repeatedly be exposed to sexual and/or physical abuse during childhood (i.e., complex trauma). Further, psychotic symptoms and bipolar disorders are not excluded with the only exception of those displaying acute suicidality at T0. Finally, to increase the generalizability of the results of the present study, we will also include male patients.

There are some potential limitations of the present study that need to be noted. First, instead of exposure therapy as the trauma-focused components, EMDR will be used, rendering a direct comparison more difficult with previous studies that employed PE as the trauma-focused therapy. However, same as PE, EMDR is one of the first-choice trauma-focused treatments for PTSD [1, 2]. An advantage of using EMDR therapy rather than imaginal exposure is that most therapists in the research setting are already well-educated in using EMDR therapy, as EMDR maybe more widely used than other trauma-focused therapies, at least in Europe [63‐65].

Furthermore, the quality of assessment of symptoms of complex PTSD is not ideal. While in clinical practice, the term complex PTSD is widely used, definitions of complex PTSD have changed over time and validated diagnostic interviews are not yet available for the current construct of CPTSD as proposed for ICD-11 [11]. Therefore, in this study, the SIDES is used to index severity of complex PTSD and additionally, a variety of psychometrically sound questionnaires to measure the different symptoms associated with complex PTSD separately (e.g. interpersonal functioning, emotion regulation, dissociation).

Most importantly, the results of this study might help to ameliorate treatment for patients suffering from PTSD due to repeated sexual and/or physical abuse during childhood thereby providing important insights on how to improve tailor-made guideline recommendations for this target group.

The second protocol version was finished in May 2016. Trial enrolment started on 5 September 2017 and recruitment is ongoing as of 31 December 2018 Additional file 1.