Is clinical DBT-PE the revolution we have all been waiting for in the treatment of victims of childhood sexual abuse?

BACKGROUND

Until only a few years ago, we had little to offer in terms of evidence based
treatment to those who suffer from the most severe consequences of childhood
sexual abuse (CSA), a combination of a posttraumatic stress disorder (PTSD) and
co-morbid conditions such as a borderline personality disorder (BPD) or
substance use disorder.

A history CSA is strongly associated with a substantial increase in the life
time risk of a variety of psychiatric disorders, including not only PTSD, but
also mood- and anxiety disorders, somatoform disorders, attention deficit
disorder, psychosis and schizophrenia, substance use disorders, suicidal
behaviour, deliberate self-harm and personality disorders.

Traditionally, treatment programs for patients with PTSD include stabilizing
interventions that are used to prepare patients with more severe forms of PTSD
for what is considered to be essential in the recovery from PTSD: exposure in
some form to trauma memories. For example, the ISTSS Expert Consensus
Guidelines for Complex PTSD propose a stepped model with three treatment
phases: 1. Stabilization and strengthening: patient safety, strengthening one*s
capacities for emotional awareness and expression, increasing positive
self-concept, addressing feelings of guilt and shame, and increase
interpersonal and social competencies. 2. Review and reappraisal of trauma
memories: re-experiencing traumatic events in the context of an actual and
subjectively experienced safe environment. 3. Consolidation of the gains of the
treatment so far.

Some experts have questioned this somewhat conservative approach to trauma
treatment. For example, some argue that there is no convincing empirical
evidence justifying the stabilization phase prior to an evidence-based trauma
treatment (EMDR of Trauma-focused cognitive behavioral therapy). In the
Netherlands, a number of experts have also suggested that trauma-focussed
therapy without a prior stabilisation phase is feasible and clinically
beneficial for patients with PTSD.

Especially in patients with a comorbid BPD, that may be characterized by
profound emotional instability, deliberate self-harm and suicidal behavior,
stability as a pre-treatment condition may be too much to ask for. Moreover,
often the symptoms and problems associated with the PTSD in turn complicate the
treatment of the personality disorder. With the two conditions complicating
and frustrating each other's treatment, therapists of victims of CSA had the
least to offer to those patients who needed it most, i.e., until recently.

In 2013, Martin Bohus and his co-workers from the Central Institute of Mental
Health in Mannheim published the results of a 12-week residential treatment
program that was specifically designed for patients with severe PTSD
complicated by comorbid conditions such as a BPD (Bohus 2013). The program
combines dialectical behavioral therapy (DBT), one of the best documented
interventions for BPD, with prolonged exposure (PE) to trauma memories (Steil
2011).

Bohus distinguishes three major challenges in the treatment of PTSD and
comorbid BPD that might interfere with the traditional treatment protocols for
PTSD. Firstly, patients with BPD are prone to exhibit emotional over-engagement
or severe dissociative symptoms during exposure. Secondly, the diversity of
trauma-related emotions and cognitions requires individualized, specific
interventions. Thirdly, the *complexity of multiple daily life problems*
referring to the problems PTSD-BPD patients often have with their daily hassles
because of their difficulties in social interaction, and their interference
with the therapeutic task. Bohus argues that, for the PTSD-BPD patients, a
modular programme that can be tailored to the actual needs of the patients is
better suited than a phase-based linear program, that often leads to early
dropout in this population.

Bohus et al. compared their intervention to a waiting list condition in a
single blind randomized design. The results of the Mannheim residential program
are very promising, with significant and clinically relevant changes in the
patient group that was randomized to the active condition, a large effect size
(a Hedges'g of 1.6), and little dropout. The treatment results on the PTSD
severity seem to be independent of severity of the personality disorder;
neither a diagnosis of BPD nor the severity of the number of BPD symptoms was
significantly related to treatment outcome.

One year earlier, in 2012, the research group of Marsha M. Linehan, founder of
DBT method, published the results of a similar combined DBT-PE treatment
program, however with a more linear design (Harned 2012). In this program, if
DBT leads to a complete disappearance of deliberate self-harm, patients are
allowed to start with prolonged exposure, while continuing with the DBT
programme. In contrast, in the Mannheim protocol, exposure starts, regardless
of the presence or absence of deliberate self-harm. Harned et al. also report
significant reductions in PTSD severity after treatment and no evidence for
exacerbations of deliberate self-harm.

Inspired by the promising results of the Mannheim program, GGZ Friesland
started a similar residential treatment program in Leeuwarden. The complete
staff of our department was trained by Martin Bohus before the first patients
were included in March 2014.

To date, there is only one published clinical trial, with less than a total of
80 randomized patients, to substantiate the claim of success of this new
intervention (Bohus 2013). It has been shown in numerous studies that the
results in first trials of new interventions are not necessarily replicated in
follow-up studies. Apart from publication bias that selects trials with
positive findings, the relation between effect and protocol adherence, the
effects of a particular psychological intervention may also be somewhat
dependent of the personal qualities of the founder and his or her team.
Implementation of the method by a different group, regardless of protocol
adherence, may not be as effective as the original one. To further solidify the
evidence base of this promising new method, follow-up studies are absolutely
necessary.

REFERENCES

Bohus, M., Dyer, A. S., Priebe, K., Kruger, A., Kleindienst, N., Schmahl, C.,
et al. (2013). Dialectical behaviour therapy for post-traumatic stress disorder
after childhood sexual abuse in patients with and without borderline
personality disorder: A randomised controlled trial. Psychotherapy and
Psychosomatics, 82(4), 221-233.

Harned, M. S., Korslund, K. E., Foa, E. B., & Linehan, M. M. (2012). Treating
PTSD in suicidal and self-injuring women with borderline personality disorder:
Development and preliminary evaluation of a dialectical behaviour therapy
prolonged exposure protocol. Behaviour Research and Therapy, 50(6), 381-386.

Steil, R., Dyer, A., Priebe, K., Kleindienst, N., & Bohus, M. (2011).
Dialectical behaviour therapy for posttraumatic stress disorder related to
childhood sexual abuse: A pilot study of an intensive residential treatment
program. Journal of Traumatic Stress, 24(1), 102-106.

The current study aims to replicate the Bohus study published in 2013,
comparing the effect of a 12-week residential DBT-PE program on the severity of
PTSD to that of a waiting list condition in patients who suffer from CSA
related PTSD and from one or more comorbid conditions such as BPD.

Question 1) What is the effect of clinical DBT-PE on the severity of PTSD at 12
weeks from the start of the program?

Secondary questions are:

Question 2) Does the effect of clinical DBT-PE depend on the presence or
absence, or the severity of symptoms of a co-morbid borderline personality
disorder?

Question 3) What is the effect of clinical DBT-PE on the frequency of and urge
for non-suicidal self-injury (NSSI) and suicidal ideation?

Question 4) What is the effect of clinical DBT-PE on the severity of the
symptoms of borderline personality disorder?

Question 5) How stable are the effects of clinical DBT-PE after the clinical
treatment program has stopped?

Question 6) What is the effect of the clinical DBT-PE on social functioning?

Question 7) What is the incremental cost-effectiveness of clinical DBT-PE as
compared to a 5-year traditional ambulatory treatment?

We propose a single-blinded randomized controlled trial (RCT), comparing our
12-week clinical DBT-PE program to a 12-week waiting list condition (WL). In
this waiting list condition, participants are allowed to continue their current
treatment with the referring therapist, except for trauma therapy. The proposed
design and choice of effect parameters deliberately concur with those of the
trial published by Bohus et al. (Bohus 2013). It is in many respects a replica,
because we want to examine the generalizability of their results to a new
treatment centre (i.e., a different team in a different country). It is single
blinded in the sense that only the observers of the treatment effect will be
blinded for the treatment condition. The proposed duration of our WL condition
(12 weeks) accidentally approximates the current average waiting time for our
program. Thus, participation with the possibility of being randomized to WL
will not pose an extra burden on our patients, as far as waiting for treatment
is concerned. For the WL condition we schedule two evaluations, the first (T0)
before randomization, the second (T1) at 12 weeks. For the DBT-PE condition, we
add a third evaluation (T2) at 24 weeks in order to examine the stability of
the treatment effects (study question 5). The follow-up duration for the
participants randomized to the WL condition in our study will be limited to 12
weeks, in contrast to the 26 weeks in the Bohus trial. Bohus et al. (2013)
demonstrated that the symptom severity among patients in the WL condition
remains essentially unchanged during the 26 weeks of follow-up.

Bohus, M., Dyer, A. S., Priebe, K., Kruger, A., Kleindienst, N., Schmahl, C.,
et al. (2013). Dialectical behaviour therapy for post-traumatic stress disorder
after childhood sexual abuse in patients with and without borderline
personality disorder: A randomised controlled trial. Psychotherapy and
Psychosomatics, 82(4), 221-233.

Dialectical behavioural therapy + prolonged exposure (DBT-PE): our clinical
DBT-PE program is very similar to the treatment program in Mannheim. Our team
has been fully trained in all details of the interventions by prof. Bohus
before we included our first patients. During the first year, our team was
supervised on a regular basis by prof. Bohus, to enhance protocol adherence.
The DBT-PE is a 12-week residential program with an intensive modular therapy
program that is specifically tailored to the individual patient. It consists of
individual treatment within a group setting; in addition to individual trauma
therapy there are numerous group modules that are targeted at increasing the
general coping skills of the participants. The program allows for a total of 25
individual psychotherapy sessions, lasting 60 minutes each.
There is a strong holding environment for the patient thanks to the 24-hour
care. The treatment entails three different phases. The first phase covers the
first three weeks during which patients prepare themselves for trauma therapy
by determining their individual goals during their therapy and learning skills
to regulate their arousal. During the second phase, from week 4 until week 9,
the focus is on skills-based prolonged exposure. Skills-based prolonged
exposure implies that patients use their skills to regulate their arousal
during the trauma therapy, allowing the patient to process his trauma. In the
last three weeks, the aim is to finalize processing of the trauma through
radical acceptance of the trauma as part of history with its consequences for
the future and the main focus will be resocialization in order to prepare to
return home.
In each phase there is a variety of treatment modules to suit the purpose of
the relevant phase. Some modules are standard, others are facultative. From
this complete set of treatment modules, a subset is selected that is tailored
to the specific needs of the participant. This individual program can be
adjusted during the course of the therapy.
There are a few small differences between our program and the Mannheim program.
Our program, for example, provides the possibility of family therapy, whereas
in Mannheim, the program allows for massages, physiotherapy and therapeutic
boxing. In Mannheim it is possible to consult a social worker about
resocialization.

Waiting list (WL): the participants randomised to the TAU-WL group, are allowed
to continue their current treatment with the referring therapist, except for
trauma therapy. For support, they are allowed to contact an independent person
who is not involved in the investigation. Participants of this group are
offered to start DBT-PE with priority after 12 weeks.

see E9