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CLINICAL STUDY PROTOCOL
published: 15 March 2019
doi: 10.3389/fpsyt.2019.00108
Frontiers in Psychiatry | www.frontiersin.org 1March 2019 | Volume 10 | Article 108
Edited by:
Xiaochu Zhang,
University of Science and Technology
of China, China
Reviewed by:
Domenico De Berardis,
Azienda Usl Teramo, Italy
Franco De Crescenzo,
University of Oxford, United Kingdom
*Correspondence:
Ana Moreno-Alcázar
amoreno1@imim.es
Specialty section:
This article was submitted to
Addictive Disorders,
a section of the journal
Frontiers in Psychiatry
Received: 15 November 2018
Accepted: 13 February 2019
Published: 15 March 2019
Citation:
Valiente-Gómez A, Moreno-Alcázar A,
Radua J, Hogg B, Blanco L, Lupo W,
Pérez V, Robles-Martínez M,
Torrens M and Amann BL (2019) A
Multicenter Phase II Rater-Blinded
Randomized Controlled Trial to
Compare the Effectiveness of Eye
Movement Desensitization
Reprocessing Therapy vs. Treatment
as Usual in Patients With Substance
Use Disorder and History of
Psychological Trauma: A Study Design
and Protocol.
Front. Psychiatry 10:108.
doi: 10.3389/fpsyt.2019.00108
A Multicenter Phase II Rater-Blinded
Randomized Controlled Trial to
Compare the Effectiveness of Eye
Movement Desensitization
Reprocessing Therapy vs. Treatment
as Usual in Patients With Substance
Use Disorder and History of
Psychological Trauma: A Study
Design and Protocol
Alicia Valiente-Gómez 1,2,3,4, 5, Ana Moreno-Alcázar 1, 2,3
*, Joaquim Radua 6,7,8 ,
Bridget Hogg 1,2 , Laura Blanco 9,10, W. Lupo 1, Víctor Pérez 2,3,4, 5, Maria Robles-Martínez 2, 4,11,
Marta Torrens 2,4,5, 11 and Benedikt L. Amann 1,2,3,4, 5
1Centre Fòrum Research Unit, Institut de Neuropsiquiatria i Addiccions, Barcelona, Spain, 2IMIM (Hospital del Mar Medical
Research Institute), Barcelona, Spain, 3Centro de Investigación Biomédica en Red de Salud Mental, Madrid, Spain, 4Institut
de Neuropsiquiatria i Addiccions, Hospital del Mar, Barcelona, Spain, 5Department of Psychiatry, Universitat Autònoma de
Barcelona, Barcelona, Spain, 6Institut d’Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain, 7Department of
Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King’s College London, London, United Kingdom,
8Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet, Stockholm, Sweden, 9Benito
Menni Complex Assistencial en Salut Mental, Sant Boi de Llobregat, Spain, 10 Department of Personality, Evaluation and
Psychological Treatments, University of Barcelona, Barcelona, Spain, 11 RETICS-Redes Temáticas de Investigación
Cooperativa en Salud en Trastornos Adictivos, Barcelona, Spain
Background: Psychological trauma has a strong negative impact on the onset, course
and prognosis of substance use disorders (SUD). Few trauma-oriented treatment
approaches have been trialed, but preliminary evidence exists of the efficacy of Eye
Movement Desensitization and Reprocessing (EMDR) therapy in improving clinical
symptoms in SUD patients.
Objective: To assess if EMDR therapy leads to: (1) reduced substance consumption;
(2) an improvement in psychopathological and in trauma-related symptoms; and (3)
an improvement in overall functioning. Our hypothesis is that the EMDR group will
improve in all variables when compared to the treatment as usual (TAU) group at 6 and
12-months visits.
Method: In this multicenter phase II rater-blinded randomized controlled trial, 142 SUD
patients with a history of psychological trauma will be randomly assigned to EMDR (n=
71) or to TAU (n=71). Patients in the EMDR group will receive 20 psychotherapeutic
sessions of 60 min over 6 months. Substance use will be measured using the Timeline
Followback Questionnaire, the Dependence Severity Scale and the Visual Analog Scale.
Valiente-Gómez et al. EMDR in Traumatized SUD Patients
Traumatic events will be measured by The Holmes-Rahe Life Stress Inventory, the
Childhood Trauma Questionnaire Scale, the Global Assessment of Posttraumatic Stress
Questionnaire, the Impact of Event Scale-Revised and the Dissociative Experiences
Scale. Clinical symptomatology will be evaluated using the Hamilton Depression Rating
Scale, the Young Mania Rating Scale and the Brief Psychiatric Rating Scale. Functionality
will be assessed with the Functioning Assessment Short Test. All variables will be
measured at baseline, post-treatment and 12 months as follow-up. Primary outcome:
to test the efficacy of EMDR therapy in reducing the severity of substance use. The
secondary outcomes: to test the efficacy in reducing trauma-related psychological
symptoms and psychopathological symptoms and in improving overall functioning in
patients with comorbid SUD and a history of psychological trauma.
Conclusion: This study will provide evidence of whether EMDR therapy is effective in
reducing addiction-related, trauma and clinical symptoms and in improving functionality
in patients with SUD and a history of trauma.
Clinical Trial Registration: The trial is registered at ClinicalTrials.gov,
identifier: NCT03517592.
Keywords: substance use disorder, addiction, psychological trauma, comorbidity, EMDR therapy, treatment
as usual
INTRODUCTION
Substance use disorders (SUD) represent an important social
and public health problem due to their negative consequences
in terms of delinquency, family disintegration, academic and
occupational disengagement, mental illness, transmission of
infectious diseases, intoxication, and mortality rates (1). One
significant risk factor for problematic alcohol and substance use
is the presence of multiple adverse childhood events, as shown
by a recent meta-analysis in the Lancet (2). Different studies
have found that between 66 and 97.4% of SUD patients have
experienced Criterion A traumatic events according to DSM
IV criteria (3–7), and the prevalence of post-traumatic stress
disorder (PTSD) in inpatients with SUD is estimated to range
from 25–51%, two to four times more than general population
rates ranging from 1.3 to 12.3% (8). Even adverse events not
meeting PTSD Criterion A have an important impact in the
course of the disorder because they have been shown to be
associated with substance use outcomes (2).
In order to clarify the difference between psychological
trauma, PTSD and subthreshold PTSD, we will provide a
brief definition of them. Psychological trauma is a term that
refers to any life event that causes discomfort to the subject
and exceeds an individual’s abilities to integrate the emotions
involved with the experience (9). The term PTSD refers to,
based on DSM-V criteria (10), exposure to actual or threatened
death, serious injury, or sexual violence, accompanied by the
presence of the following trauma-related symptoms: intrusion,
persistent avoidance of stimuli, negative alterations in cognitions
and mood and marked alterations in arousal and reactivity.
Symptoms must have a duration of more than 1 month
and cause clinically significant distress or impairment in the
patient’s overall functioning, and not be attributable to the
physiological effects of a substance or another medical condition
(10). Finally, the term subthreshold PTSD should be used
when the clinical presentation does not meet all criteria for
PTSD diagnosis.
A large study into populations addicted to alcohol and various
illicit drugs found that PTSD and subsyndromal PTSD were
correlated with addiction severity, a worse disease prognosis,
more hospital admissions, poorer response to treatment,
shorter periods of abstinence and greater craving (4). These
characteristics make this specific population difficult to treat.
In addition, trauma is highly prevalent in patients with severe
mental disorders (SMDs) such as depression, bipolar disorder
or psychosis, where PTSD and SUD are frequently comorbid
and negatively influence the course of mental illness (11,12).
In some cases, disease course is worsened by a high prevalence
of trauma-related dissociative symptoms (13). These findings
suggest psychological trauma should be assessed in SUD and in
dual pathology patients and be included as an objective of the
treatment plan (12,14).
Along these lines, even though pharmacological treatment
such as selective serotonin reuptake inhibitors, atypical
antipsychotics and benzodiazepines have demonstrated a limited
efficacy in the treatment of PTSD and psychological trauma,
some drugs such as prazosin could be a promising strategy to
consider in adjuvant treatment with the psychological approach,
given the positive results shown in specific PTSD symptoms as
reported the meta-analysis of Berardis et al. (15).
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Valiente-Gómez et al. EMDR in Traumatized SUD Patients
TABLE 1 | SPIRIT flow diagram: schedule of enrolment, interventions, and
assessments.
Study period
Enrolment Allocation Post-allocation Close-out
TIMEPOINT –t1& t00t1t2T3
ENROLMENT
Eligibility screen X
PRISM X
MINI X
HDRS X X X
YMRS X X X
BPRS X X X
TLFB X X X X
SDS X X X X
EVA X X X X
CTQ X
H-RLSI X
EGEP X X X
IES-R X X X
DES X X X
Informed consent X
Allocation X
INTERVENTIONS
EMDR
TAU
ASSESSMENTS
FAST X X X
PRISM, Psychiatric Research Interview for Substance and Mental Disorders; MINI,
Mini-International Neuropsychiatric Interview; HDRS, Hamilton Depression Rating Scale;
YMRS, Young’s scale for the evaluation of the Mania; BPRS, Brief Scale of Psychiatric
Evaluation; TLFB, Timeline Followback; SDS, Dependence severity scale; EVA, Analog
visual scale; CTQ, Childhood Trauma Questionnaire; H-RLSI, The Holmes-Rahe Life
Stress Inventory; EGEP, Global Assessment of Posttraumatic Stress Questionnaire; IES-R,
Scale of the impact of events reviewed; DES, Scale of Dissociative Experiences; EMDR,
Eye movement desensitization and reprocessing therapy; TAU, Treatment as usual; FAST,
Functioning Assessment Short Test.
A recent Cochrane review into the efficacy of CBT-
based therapies for comorbid SUD and PTSD found that
preliminary evidence showed that trauma-focused therapy
delivered alongside SUD therapy could improve PTSD symptoms
at short- and long-term, and SUD symptoms at long-term,
compared to treatment as usual. They concluded that more
research is needed on trauma-focused therapies for this
population, but that there is very little evidence to support
individual therapies not focused on trauma (16).
One leading trauma-focused treatment is Eye Movement
Desensitization and Reprocessing (EMDR) therapy,
recommended as a first-line PTSD treatment by international
bodies such as the American Psychiatric Association (APA)
(17) and the World Health Organization (WHO) (18). Initial
studies have shown the potential for EMDR to be applied to
the SUD population. Until nowadays, there are three published
trials in SUD and EMDR: two small randomized controlled
trials (RCT) and one non-randomized controlled trial of EMDR
vs. treatment as usual (TAU) in patients with SUD (19–21).
They have suggested that EMDR, compared to the control
group, significantly improves craving (19), depression, anxiety,
self-esteem (19,20), and dissociative symptoms (21), but results
must be repeated with larger samples. A large scale RCT is
currently underway (22) to determine the efficacy of EMDR in
reducing PTSD symptoms in an inpatient sample with comorbid
SUD and PTSD or sub-threshold PTSD.
In the current study, we aim to carry out the first large RCT
into the impact of EMDR on SUD symptoms in outpatients
(with or without comorbid SMDs) with a history of psychological
trauma. This is groundbreaking in, firstly, focusing on addiction
outcomes instead of PTSD symptoms as a primary outcome and,
secondly, in including all patients showing trauma-associated
symptoms, even if they do not fulfill PTSD or subsyndromal
PTSD criteria.
Additionally, EMDR is an interesting psychotherapeutic tool
for this population due to its potential to improve the course
of comorbid SMDs, where strong preliminary evidence also
shows EMDR to be a promising treatment beyond PTSD (23),
such as in bipolar disorder (24), or psychosis (25), as well as
in depression (26,27) and anxiety (28–30). The evidence that
EMDR is efficacious in these kind of patients will help facilitate
its application in complex real-world settings.
METHODS
This is a multicenter phase II rater-blinded randomized
controlled trial, phase II, with two parallel branches, EMDR and
TAU, of patients diagnosed with SUD who have a comorbid
history of psychological trauma, even if they do not currently
meet DSM-V criteria for PTSD. The patients will be matched
by site, age, sex, and diagnosis. One group will consist of TAU
plus 20 individual 60-min EMDR sessions over a duration of 6
months, while the other group will receive TAU only. Patients
will be evaluated at baseline (T0), 3 months (T1: only substance
use-related symptoms), post-treatment at 6 months (T2), and
at 12 months as follow-up (T3) (see Table 1). Clinical raters
carrying out evaluations will be blind to the participants’ research
condition. Patients will not be blind to treatment as a sham
alternative to EMDR therapy is impossible due to its use of
bilateral stimulation.
The study has been approved by the Ethic Committees
of the Hospital Benito Menni, Germanes Hospitalàries del
Sagrat Cor de Jesús (PR-2018-04), and the IMIM, Parc de
Salut Mar (2017/7615/I). All participants will sign informed
consent prior to enrollment. Details of the trial design can
be also gathered from Supplementary Material (Standard
Protocol Items: Recommendations for Interventional Trials
[SPIRIT] Checklist).
This is a multicenter phase II collaborative project will
involve the participation of five different centers from the
Barcelona catchment area, Spain: four outpatient addiction
clinics pertaining to the Institute of Neuropsychiatry and
Addictions (INAD), Parc de Salut Mar, and a fifth pertaining
to the Hospital Benito Menni, in Sant Boi de Llobregat.
Both institutions involved are centers of reference in mental
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Valiente-Gómez et al. EMDR in Traumatized SUD Patients
health treatment and research, facilitating the recruitment and
development of the project. EMDR therapists have extensive
experience in EMDR protocols and SUD. All participating raters
will be trained in the blind-to-treatment application of all
clinical assessments.
Study Outcomes
The primary outcome is to test the efficacy of EMDR therapy in
reducing the severity of substance use in patients with comorbid
SUD and a history of psychological trauma, irrespective of
whether the patient meets DSM-V PTSD criteria. Changes from
baseline in the severity of substance use are measured by the
Timeline Follow Back (TLFB) (31), the Severity of Dependence
Scale (SDS) (32), and the Visual Analog Scale (VAS).
The secondary outcome is to test the efficacy of EMDR
in improving trauma-related psychological symptoms,
psychopathological symptoms, and the overall functionality
in SUD patients with a history of psychological trauma.
Changes in psychological trauma and dissociative symptoms are
measured using the Global Assessment of Posttraumatic Stress
Questionnaire (EGEP-5) (33), the Impact of Event Scale-Revised
(IES-R) (34), and the Dissociative Experiences Scale (DES) (35),
respectively. The type and severity of traumatic experiences are
measured using the Childhood Trauma Questionnaire (CTQ)
(36) and The Holmes-Rahe Life Stress Inventory (37). Changes
in psychopathological symptoms are measured by the Hamilton
Depression Rating Scale (HDRS) (38), Young Mania Rating
Scale (YMRS) (39), and the Brief Psychiatric Rating Scale (BPRS)
(40). Changes in overall functioning will be measured using the
Functioning Assessment Short Test (FAST) (41).
Hypotheses
1. Patients in the EMDR group will show a reduction in the level
and severity of substance use-related symptoms as compared
to the TAU group.
2. Patients in the EMDR group will show a reduction in the
number of relapses as compared to the TAU group.
3. Patients in the EMDR group will show a reduction in the
severity of trauma-related symptoms as compared to the
TAU group.
4. There will be a reduction in depressive symptoms associated
with a comorbid psychiatric disorder in the EMDR group as
compared to the TAU group.
5. There will be a reduction in (hypo) manic symptoms
associated with a comorbid psychiatric disorder in the EMDR
group as compared to the TAU group.
6. There will be a reduction in general psychopathology
symptoms associated with psychiatric comorbidity in the
EMDR group as compared to the TAU group.
7. Patients in the EMDR group will show an improvement in
functioning as compared to the TAU group.
Study Participants
The study sample will consist of 142 outpatients fulfilling the
criteria of the Diagnostic and Statistical Manual of Mental
Disorders, fifth edition (DSM-5), for SUD based on a clinical
interview (Psychiatric Research Interview for Substance and
Mental Disorders; PRISM) (42) and a review of case notes.
Inclusion criteria are: (1) aged 18–65, (2) outpatient, and
(3) presence of one or more traumatic events currently causing
trauma-associated symptoms (Impact of Events Scale-Revised,
IES-R >0) and Subjective Disturbance Unit (SUD) >5, that
assesses subjective disturbance in a scale between 0 and 10, but
it is not necessary that traumatic events meet DSM-5 criteria
for PTSD.
Exclusion criteria are: (1) presence of organic brain diseases,
(2) presence of acute suicidal ideation, (3) having received a
trauma-focused therapy or attended psychotherapeutic groups
for survivors of violence within the last 2 years, or (4) acute
episode of comorbid psychiatric disorder.
Randomization Procedure
Clinical trials use randomization to balance confounding factors
(to an uncontrolled extent) and to conceal allocation. However,
complete randomization in small to moderate studies may fail
to balance groups, severely affecting inference. To overcome
this issue Efron (43) introduced the biased coin methods,
which randomize each patient to one or the other group
with a probability or another with the aim of increasing
the balance of known confounding factors. Importantly, these
methods still randomize each of the patients, thus balancing
the unknown confounding factors (to the uncontrolled extend
that complete randomization does) and concealing allocation
(44). Non-deterministic dynamic allocation designs, such as
the biased coin methods, were included in international
guidelines for drug clinical trials (45) adopted by the European
Community, Japan, United States FDA, Canada and Switzerland
(Implementation of E9 Statistical Principles for Clinical Trials.
URL: https://www.ich.org/products/guidelines/efficacy/efficacy-
single/article/statistical-principles-for-clinical-trials.html).
In this trial, all patients meeting the inclusion criteria will
receive the baseline (T0) assessment. After T0, participants will
be assigned to the EMDR or TAU group following a biased
coin procedure (46): (1) the first two patients will be randomly
allocated to EMDR with p=0.5, (2) the next patient will be
allocated as follows: (b1) if one group already includes at least two
more patients than the other group, the patient will be randomly
allocated to EMDR with p=0.8 is this is the smallest group and
with p=0.2 if it is the largest group, (b2) otherwise, we will first
simulate that the patient is allocated to EMDR and calculate the
sum of the between-group square standardized differences in site,
age, sex, diagnosis (dual vs. not dual) and number of substances
consumed during the month before the randomization (none.
one or more than one), we will then simulate that the patient is
allocated to TAU and recalculate the sum, and finally randomly
allocate the patient to EMDR with p=0.8 if this was associated
to the smallest sum and with p=0.2 if not. For example, if
we had already included 10 patients to the EMDR group and 8
patients to the TAU group, the 19th patient would be randomly
allocated with p=0.2 for EMDR and p=0.8 for TAU. If
he/she was allocated to TAU, for the 20th patient we would
calculate the above sum of covariates after simulating that the
he/she is allocated to EMDR and after simulating that he/she is
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Valiente-Gómez et al. EMDR in Traumatized SUD Patients
allocated to TAU, and if the sum of the EMDR simulation was
larger than the sum of the TAU simulation, we would randomly
allocate the 20th patient with p=0.2 for EMDR and p=0.8
for TAU. Following this procedure, the final groups should be
balanced in size and matched in site, age, sex and diagnosis. All
steps of the randomization process will be automatically carried
out by an independent researcher in a central location using a
computer program.
Computation of Sample Size
The study aims to assess the efficacy of EMDR therapy compared
with TAU, in inpatients with SUD, in terms of a reduction in
substance use, a reduction in symptoms associated with craving
and associated symptoms of anxiety and depression, and an
improvement in functioning.
We aim for the study to be able to detect medium-sized
differences in the pre-post changes between groups with an
80% statistical power. Given that there are no previous studies
that report the variability of these changes, we have defined
medium-sized differences as those with a medium effect size (d
=0.5). With the function power.t.test from R (http: //www.r-
project.org/), we have calculated that the number of patients
required to detect medium-sized differences (d=0.5) with
a statistical power of 80% is n=64 per intervention group
(two groups, total n=128). Assuming a loss percentage of
approximately 10% of the patients in the study, it would be
necessary to recruit approximately 142 patients, 71 for each
intervention branch.
Statistical Analysis
The distribution of socio-demographic and clinical
characteristics between groups in the baseline state will be
summarized using descriptive statistics. The change in clinical
and functional variables with regard to baseline evaluation
at strategic points of the intervention will be analyzed using
mixed-effects repeated-measures linear models, including as
fixed factors time, treatment conditions and their interactions,
and as a random factor the site. The differences between groups,
for the categorical variables and main clinics, will be analyzed
by adding covariates to the models. Those covariates that are
statistically significant may be added in the same model to
determine which covariates are best predictors of the response.
The size of the effects will be estimated using the g of Hedges or
the r of Pearson. It will be corrected for multiple comparisons.
The statistical software used for the analysis will be the latest
available version of R. We will conduct an intention to treat
(ITT) analysis. The “Last Observation Carried Forward” (LOCF)
method will be used for losses of follow-up.
STEPWISE PROCEDURES
Intervention
EMDR
Patients in the EMDR condition will receive 20 individual
sessions of 60 min each, using the standard EMDR therapy
protocol developed by Shapiro (47) and a further specific
protocol for SUD, the CRAVEX protocol, developed by
Hase (48) to treat both trauma-related symptoms and SUD
symptoms, respectively.
The current standard protocol includes eight phases, briefly
described below:
1. Patient history: The therapist assesses the patient’s attachment
history, medical history, physical problems and identifies
traumatic events and their relationship to current symptoms.
A treatment plan is developed.
2. Patient preparation: A safe therapeutic environment is
established, the theory and processes of EMDR are explained,
and the therapist may try out different modalities of
bilateral stimulation, including eye movements, where the
patient’s eyes follow the therapist’s fingers moving in
horizontally or diagonally across their field of vision.
While eye movements are generally recommended, if
they are not well-tolerated, another modality, such as
tapping the back of the patient’s hands or auditory tones,
may be used.
3. Patient assessment: The therapist helps the patient to bring the
traumatic memory to mind and identify associated cognitions,
emotions and physical sensations. The patient identifies the
image which represents the worst part of the traumatic
memory and an associated negative cognition, and is helped to
identify a positive cognition to replace this. Finally, the patient
identifies the distress level they experience upon bringing
the traumatic experience and negative cognition to mind.
Distress is measured using the Subjective Units of Disturbance
Scale (SUD), scored from 0 (minimum disturbance) to 10
(maximum disturbance).
4. Memory desensitization: The patient brings to mind the
traumatic image, negative cognition and associated emotion
and notices any physical discomfort generated in the present
moment. The patient focuses on this material and a 30–40 s
set of bilateral stimulation is applied, during which the patient
is instructed to observe what is happening without judgment,
and afterwards express what occurred. The therapist asks
the patient to focus on new material without comment,
assessment, or interpretation. This is repeated until no new
material arises and the traumatic memory generates no
distress (SUD =0 or 1).
5. Installing the positive cognition: The patient brings the
positive cognition and original experience to mind. Further
sets of bilateral stimulation are applied, causing the patient to
link the positive cognition with the original memory, until the
positive belief is fully installed.
6. Body scan: The therapist asks the patient to close their eyes
and focus on the original experience and positive cognition,
and to notice if any sensation arises. If a negative or
uncomfortable sensation is reported, the therapist will resume
bilateral stimulation until it disappears. If the sensation is
positive, it will be reinforced with short sets (10–12 s) of
bilateral stimulation.
7. Closure: The therapist explains possible effects following the
session, such as new insights, thoughts, memories, and even
dreams or nightmares, and offers recommendations about
what to do in each case.
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Valiente-Gómez et al. EMDR in Traumatized SUD Patients
TABLE 2 | Measurements to evaluate consumption symptoms.
Clinical
variable
Measurement
interview/
Self-report
T0 T1 T2 T3
Baseline Mid-
treatment
Post-
treatment
Post-
treatment
6 months 12 months
Timeline TLFB x x x x
Dependence SDS x x x x
Craving EVA x x x x
TLFB, Timeline Followback Questionnaire; SDS, Severity of Dependence Scale; EVA,
Visual Analog Scale.
8. Reevaluation: The therapist assesses the patient’s experiences
since the previous session and reevaluates the traumatic
memory to confirm functional processing. If the memory has
been desensitized, the therapist selects a new target of either
another traumatic memory, a current trigger of distress, or a
potentially threatening future event.
The CRAVEX protocol (48) will also be applied to process
craving. This protocol focuses on the concept of addiction
memory (AM), in which the biological effect of the drugs has
a serious impact on the brain comparable to trauma, which
leads to the formation of a maladaptive implicit memory which
if reprocessed can decrease cravings or urges, and potentially
promote access to the brain channels connected to the initial
reasons the individual became addicted (49). Instead of SUD,
the CRAVEX protocol uses Level of Urge (LOU), with a scale of
0 (no urge) to 10 (worst urge imaginable), referring to the urge
to consume the substance. As in the standard protocol, positive
and negative cognitions, emotions and physical sensations are
identified but, in this case, they are associated with the last time
that the subject consumed the drug. Bilateral stimulation is used
until the AM is desensitized, and finally the positive cognition
is installed.
TAU
All patients included in this study will participate in the TAU
condition, comprising the standard care package offered by the
Drug and Alcohol Outpatient Unit. This is a multidisciplinary
unit with doctors, psychiatrists, clinical psychologists, nurses, and
social workers on the staff. An individual care plan is drawn
up depending on individual needs and may include follow-up
psychiatric visits to evaluate clinical status and, if necessary,
readjust pharmacological treatment, and psychological visits to
assess and detect risk situations and prevent relapses using a non-
trauma focused CBT. In no case will psychological treatment
focus on PTSD. TAU also includes nurse visits for health and
self-care habits and nurses may also carry out abstinence controls.
Dropouts and Follow-Up
If a participant requires an inpatient stay due to substance misuse
or an acute episode of a comorbid disorder during the 6-month
intervention period, the patient will be excluded from the trial
and considered as dropout because the hospital admission will
mean the patient cannot continue with the EMDR psychotherapy
TABLE 3 | Measurements to evaluate psychological trauma symptoms.
Clinical
variable
Measurement
interview/
Self-report
T0 T1 T2 T3
Baseline Mid-
treatment
Post-
treatment
Post-
treatment
6 months 12 months
Childhood T CTQ x
PTSD EGEP x x x
Traumatic
events
H-RLSI x
Trauma’s
impact
IES-R x x x
Dissociation DES x x x
Childhood T, Childhood trauma; CTQ, Childhood Trauma Questionnaire; PTSD,
post-traumatic stress disorder; EGEP, Global Assessment of Posttraumatic Stress
Questionnaire; H-RLSI, The Holmes-Rahe Life Stress Inventory; IES-R, Impact Event
Scale; DES, Scale of Dissociative Experiences.
during the acute phase. In the case of relapse during follow-
up, patients will be maintained in the trial to obtain maximum
information on the course of the illness.
MATERIALS AND EQUIPMENT
Instruments and Measures
The consumption of substances will be quantified using the
following tools (see Table 2):
1. Timeline Followback Questionnaire (TLFB): The TLFB (31)
is a retrospective calendar-based measure of daily substance
use, initially developed to obtain self-reports of alcohol use but
nowadays also used for other substances.
2. Severity of Dependence Scale (SDS): The SDS (32) is a 5-
item questionnaire indicating the degree of dependence on
different types of drugs. Each item is scored on a 4-point
scale (0–3) and summed to create a total score. Higher scores
indicate greater dependence.
3. Visual Analog Scale (VAS): A self-report scale to measure
craving intensity, classically used to measure pain intensity.
It ranges from 0 to 10: the higher the score, the greater the
craving severity.
Trauma-related symptoms will be evaluated using the tools listed
in Table 3:
1. Childhood Trauma Questionnaire (CTQ): The CTQ (36),
Spanish validation (50), is a self-administered 28-item scale
developed as a screening tool for histories of childhood abuse
and neglect, with 5 subscales: emotional, physical or sexual
abuse, and emotional or physical neglect. A 5-point Likert
scale is used for the responses, ranging from “Never True” to
“Very Often True.”
2. Global Assessment of Posttraumatic Stress
Questionnaire(EGEP-5): The EGEP-5 (51) is a clinical
interview for the diagnosis of PTSD, both current and in
the past, based on DSM-V criteria. This scale contains three
sections: events, symptoms and functioning.
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Valiente-Gómez et al. EMDR in Traumatized SUD Patients
3. The Holmes-Rahe Life Stress Inventory (37); Spanish
validation (52): this is a scale assessing the frequency of
43 common stressful life events over the past 12 months,
providing a standardized measure of their impact (53). Scores
below 150 reflect low levels of stress, scores between 150
and 299 represent a 50% risk of a stress-related illness in
the near future and scores above 300 represent an 80% risk
(37), although each individual’s reactions to stress and coping
ability must be considered.
4. Impact of Event Scale-Revised (IES-R): The IES-R (54),
Spanish validation (55), is a 22-item self-report measure of
subjective distress over the previous 7 days related to a specific
stressful life event. Items correspond directly to 14 of the 17
DSM-IV symptoms of PTSD. Items are rated on a 5-point
scale ranging from 0 and 4, yielding a total score ranging
from 0 to 88, with subscale scores for Intrusion, Avoidance,
and Hyperarousal.
5. Dissociative Experiences Scale (DES): The DES (36), Spanish
validation (56), is a 28-item self-reported questionnaire
measuring a wide range of dissociative experiences, from
normal to pathological, with an overall mean score ranging
from 0 to 100 (57).
Diagnosis, clinical symptoms, and functioning will be assessed
using the following instruments (see Table 4):
1. The clinical diagnosis of SUD will be made according to
DSM-5 criteria, using the Spanish version of the clinical
interview Psychiatric Research Interview for Substance and
Mental Disorders (PRISM) (42).
2. Mini-International Neuropsychiatric Interview (MINI): A
Spanish-validated brief structured diagnostic interview to
assess the 17 most common psychiatric disorders as per DSM-
IV criteria (58).
3. Hamilton Depression Rating Scale (HDRS): The HDRS (38),
Spanish validation (59), is a 17-item hetero-administered scale
designed to be used in patients previously diagnosed with
depression, to quantitatively assess the severity of and changes
in depressive symptoms. Each item has three or five possible
answers, scored 0–2 or 0–4, respectively. Total scores range
from 0 to 52.
4. Young Mania Rating Scale (YMRS): The YMRS (39), Spanish
validation (60), is an 11-item hetero-administered scale which
quantifies the severity of manic and hypomanic episodes.
Four items are given more weight to compensate for
poor cooperation from severely ill patients and are graded
on a 0–8 scale (irritability, speech, thought content and
disruptive/aggressive behavior), while the remaining seven
items are graded on a 0–4 scale.
5. Brief Psychiatric Rating Scale (BPRS): The BPRS (40), Spanish
validation (61), is an 18-item hetero-administered scale
measuring psychopathological changes. It includes anxious,
affective and psychotic symptoms, with each rated on a
severity scale of 1–7.
6. Functioning Assessment Short Test (FAST): The FAST (41)
is a 24-item instrument to evaluate functioning in six areas:
autonomy, occupational functioning, cognitive functioning,
finances, relationships and leisure. Each item is rated on
TABLE 4 | Measurements to evaluate clinical symptoms and functionality.
Clinical
variable
Measurement
interview/
Self-report
T0 T1 T2 T3
Baseline Mid-
treatment
Post-
treatment
Post-
treatment
6 months 12 months
Diagnosis PRISM x
Diagnosis MINI x
Mania YMRS x x x
Depression HDRS x x x
Psychiatric S. BPRS x x x
Functionality FAST x x x
PRISM, Psychiatric Research Interview for Substance and Mental Disorders; MINI,
Mini-International Neuropsychiatric Interview; YMRS, Young Mania Rating Scale; HDRS,
Hamilton Depression Rating Scale; Psychiatric S, Psychiatric symptoms; BPRS, Brief
Scale of Psychiatric Evaluation, FAST, Functioning Assessment Short Test; Psychiatric
S, Psychiatric symptoms.
a 4-point scale and summed to obtain a global score
ranging from 0 to 72. The higher scores indicate poorer
functional status.
Anticipated Results
The expected results of the current study will provide
evidence of whether EMDR therapy is effective in reducing
symptoms related to substance use, trauma-related and clinical
symptoms in outpatients with SUD and a comorbid history of
psychological trauma.
DISCUSSION
In recent years, the third-generation psychotherapies such as
EMDR, which emerged in the 90s within the tradition of
behavioral therapy (62), have gained considerable interest in
both social and scientific fields due to their ability to integrate
cognitive, emotional and behavioral components within the
same psychotherapeutic approach, processing adverse life events
and therefore ameliorating associated psychiatric symptoms. To
date, preliminary evidence exists suggesting EMDR therapy is
efficacious in SUD patients, thanks to previous studies done
in that population (20,63). In a more recent publication (21),
a quasi-experimental study of 40 SUD outpatients found that
EMDR as an add-on treatment had a pronounced effect in
reducing post-traumatic and dissociative symptoms and also
caused a significant improvement in the global severity of
psychiatric symptoms. The aim of our trial is to provide further
evidence of a positive effect of EMDR in this difficult-to-
treat population in a larger RCT. In our study, we aim to
treat real-world dual patients, with a wide range of substances
used and varied comorbid psychiatric and somatic illnesses
(except neurological disorders). In contrast to prior studies,
we also include a year follow-up to test whether possible
improvements are maintained. With results from a large RCT,
we aim to promote trauma-oriented therapies in patients with
dual disorders. Although it has been shown that there is a
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Valiente-Gómez et al. EMDR in Traumatized SUD Patients
clear association between PTSD and addiction (64), most mental
health care programs do not offer trauma-oriented therapies
for patients with SUD. To understand better the relationship
between the presence of traumatic events and the diagnosis
of SUD, we will study several variables before, during and
after treatment. We will assess variables of clinical severity,
consumption and overall functioning with specific and validated
instruments. In short, the potential of this study is to demonstrate
the effectiveness and safety of EMDR in dual disorders. Along
these lines, we could be closer to establishing an effective new
psychological treatment for these patients in addition to the
standard treatment. In this way, the impact of this trial is to
improve the clinical evolution and prognosis and to reduce
hospital admissions in SUD patients.
LIMITATIONS
A limitation of this study is the inclusion of heterogeneous
patients with various psychiatric diagnoses, including SUD
with somatic and other psychiatric comorbidities. This trial
has been specifically designed as a pragmatic real-world study
with few exclusion criteria. We believe this limitation can
be sufficiently controlled by matching samples in both arms
and by the fact that the main common clinical underlying
variable of all patients is a comorbid psychological trauma.
Furthermore, the lack of control regarding drug treatment
is a potential source of bias. To partly overcome this
limitation, the “pharmacological treatment” variable will be
taken into account and the treatment regimen should not
be changed as far as possible, once patients have been
stabilized. Moreover, it should be noted that our center
has extensive experience in the treatment of SUD and uses
standardized treatment protocols, which will also help limit this
potential issue.
AUTHOR CONTRIBUTIONS
BA and MT had the idea for the project. AV-G, AM-A, LB,
MR-M, and BA contributed to the design of the study. AV-G
wrote the first draft of the manuscript, with supervision from
AM-A, BH, and BA (primary supervisor). JR will carry out
the randomization of patients and the statistical analyses. JR,
LB, BH, WL, MR-M, VP, and MT contributed to the revisions
and modifications of the manuscript and all have approved the
final version.
FUNDING
This work is supported by a PERIS Grant (SLT006/17/00038)
from the Catalonia Government. The sources of funding have no
influence on the design and the conducting and the reporting of
the trial.
SUPPLEMENTARY MATERIAL
The Supplementary Material for this article can be found
online at: https://www.frontiersin.org/articles/10.3389/fpsyt.
2019.00108/full#supplementary-material
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Conflict of Interest Statement: BA is the Research Committee Chair of EMDR
Europe and he has been invited as speaker to various national and international
congresses of EMDR. WL is supervisor of the Spanish Association of EMDR.
The remaining authors declare that the research was conducted in the absence of
any commercial or financial relationships that could be construed as a potential
conflict of interest.
Copyright © 2019 Valiente-Gómez, Moreno-Alcázar, Radua, Hogg, Blanco, Lupo,
Pérez, Robles-Martínez, Torrens and Amann. This is an open-access article
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