CLINICAL STUDY PROTOCOL published: 15 March 2019 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 Edited by: Xiaochu Zhang, Design and Protocol University of Science and Technology of China, China 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 , Reviewed by: Domenico De Berardis, Marta Torrens 2,4,5,11 and Benedikt L. Amann 1,2,3,4,5 Azienda Usl Teramo, Italy 1 Centre Fòrum Research Unit, Institut de Neuropsiquiatria i Addiccions, Barcelona, Spain, 2 IMIM (Hospital del Mar Medical Franco De Crescenzo, Research Institute), Barcelona, Spain, 3 Centro de Investigación Biomédica en Red de Salud Mental, Madrid, Spain, 4 Institut University of Oxford, United Kingdom de Neuropsiquiatria i Addiccions, Hospital del Mar, Barcelona, Spain, 5 Department of Psychiatry, Universitat Autònoma de *Correspondence: Barcelona, Barcelona, Spain, 6 Institut d’Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain, 7 Department of Ana Moreno-Alcázar Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King’s College London, London, United Kingdom, 8 amoreno1@imim.es Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet, Stockholm, Sweden, 9 Benito Menni Complex Assistencial en Salut Mental, Sant Boi de Llobregat, Spain, 10 Department of Personality, Evaluation and Specialty section: Psychological Treatments, University of Barcelona, Barcelona, Spain, 11 RETICS-Redes Temáticas de Investigación This article was submitted to Cooperativa en Salud en Trastornos Adictivos, Barcelona, Spain Addictive Disorders, a section of the journal Frontiers in Psychiatry Background: Psychological trauma has a strong negative impact on the onset, course and prognosis of substance use disorders (SUD). Few trauma-oriented treatment Received: 15 November 2018 Accepted: 13 February 2019 approaches have been trialed, but preliminary evidence exists of the efficacy of Eye Published: 15 March 2019 Movement Desensitization and Reprocessing (EMDR) therapy in improving clinical Citation: symptoms in SUD patients. Valiente-Gómez A, Moreno-Alcázar A, Radua J, Hogg B, Blanco L, Lupo W, Objective: To assess if EMDR therapy leads to: (1) reduced substance consumption; Pérez V, Robles-Martínez M, (2) an improvement in psychopathological and in trauma-related symptoms; and (3) Torrens M and Amann BL (2019) A Multicenter Phase II Rater-Blinded an improvement in overall functioning. Our hypothesis is that the EMDR group will Randomized Controlled Trial to improve in all variables when compared to the treatment as usual (TAU) group at 6 and Compare the Effectiveness of Eye Movement Desensitization 12-months visits. Reprocessing Therapy vs. Treatment Method: In this multicenter phase II rater-blinded randomized controlled trial, 142 SUD as Usual in Patients With Substance Use Disorder and History of patients with a history of psychological trauma will be randomly assigned to EMDR (n = Psychological Trauma: A Study Design 71) or to TAU (n = 71). Patients in the EMDR group will receive 20 psychotherapeutic and Protocol. Front. Psychiatry 10:108. sessions of 60 min over 6 months. Substance use will be measured using the Timeline doi: 10.3389/fpsyt.2019.00108 Followback Questionnaire, the Dependence Severity Scale and the Visual Analog Scale. Frontiers in Psychiatry | www.frontiersin.org 1 March 2019 | Volume 10 | Article 108 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 Symptoms must have a duration of more than 1 month and cause clinically significant distress or impairment in the Substance use disorders (SUD) represent an important social patient’s overall functioning, and not be attributable to the and public health problem due to their negative consequences physiological effects of a substance or another medical condition in terms of delinquency, family disintegration, academic and (10). Finally, the term subthreshold PTSD should be used occupational disengagement, mental illness, transmission of when the clinical presentation does not meet all criteria for infectious diseases, intoxication, and mortality rates (1). One PTSD diagnosis. significant risk factor for problematic alcohol and substance use A large study into populations addicted to alcohol and various is the presence of multiple adverse childhood events, as shown illicit drugs found that PTSD and subsyndromal PTSD were by a recent meta-analysis in the Lancet (2). Different studies correlated with addiction severity, a worse disease prognosis, have found that between 66 and 97.4% of SUD patients have more hospital admissions, poorer response to treatment, experienced Criterion A traumatic events according to DSM shorter periods of abstinence and greater craving (4). These IV criteria (3–7), and the prevalence of post-traumatic stress characteristics make this specific population difficult to treat. disorder (PTSD) in inpatients with SUD is estimated to range In addition, trauma is highly prevalent in patients with severe from 25–51%, two to four times more than general population mental disorders (SMDs) such as depression, bipolar disorder rates ranging from 1.3 to 12.3% (8). Even adverse events not or psychosis, where PTSD and SUD are frequently comorbid meeting PTSD Criterion A have an important impact in the and negatively influence the course of mental illness (11, 12). course of the disorder because they have been shown to be In some cases, disease course is worsened by a high prevalence associated with substance use outcomes (2). of trauma-related dissociative symptoms (13). These findings In order to clarify the difference between psychological suggest psychological trauma should be assessed in SUD and in trauma, PTSD and subthreshold PTSD, we will provide a dual pathology patients and be included as an objective of the brief definition of them. Psychological trauma is a term that treatment plan (12, 14). refers to any life event that causes discomfort to the subject Along these lines, even though pharmacological treatment and exceeds an individual’s abilities to integrate the emotions such as selective serotonin reuptake inhibitors, atypical involved with the experience (9). The term PTSD refers to, antipsychotics and benzodiazepines have demonstrated a limited based on DSM-V criteria (10), exposure to actual or threatened efficacy in the treatment of PTSD and psychological trauma, death, serious injury, or sexual violence, accompanied by the some drugs such as prazosin could be a promising strategy to presence of the following trauma-related symptoms: intrusion, consider in adjuvant treatment with the psychological approach, persistent avoidance of stimuli, negative alterations in cognitions given the positive results shown in specific PTSD symptoms as and mood and marked alterations in arousal and reactivity. reported the meta-analysis of Berardis et al. (15). Frontiers in Psychiatry | www.frontiersin.org 2 March 2019 | Volume 10 | Article 108 Valiente-Gómez et al. EMDR in Traumatized SUD Patients TABLE 1 | SPIRIT flow diagram: schedule of enrolment, interventions, and They have suggested that EMDR, compared to the control assessments. group, significantly improves craving (19), depression, anxiety, Study period self-esteem (19, 20), and dissociative symptoms (21), but results must be repeated with larger samples. A large scale RCT is Enrolment Allocation Post-allocation Close-out currently underway (22) to determine the efficacy of EMDR in TIMEPOINT –t1 & t0 0 t1 t2 T3 reducing PTSD symptoms in an inpatient sample with comorbid SUD and PTSD or sub-threshold PTSD. ENROLMENT In the current study, we aim to carry out the first large RCT Eligibility screen X into the impact of EMDR on SUD symptoms in outpatients PRISM X (with or without comorbid SMDs) with a history of psychological MINI X trauma. This is groundbreaking in, firstly, focusing on addiction HDRS X X X outcomes instead of PTSD symptoms as a primary outcome and, YMRS X X X secondly, in including all patients showing trauma-associated BPRS X X X symptoms, even if they do not fulfill PTSD or subsyndromal TLFB X X X X PTSD criteria. SDS X X X X Additionally, EMDR is an interesting psychotherapeutic tool EVA X X X X for this population due to its potential to improve the course CTQ X of comorbid SMDs, where strong preliminary evidence also H-RLSI X shows EMDR to be a promising treatment beyond PTSD (23), EGEP X X X such as in bipolar disorder (24), or psychosis (25), as well as IES-R X X X in depression (26, 27) and anxiety (28–30). The evidence that DES X X X EMDR is efficacious in these kind of patients will help facilitate Informed consent X its application in complex real-world settings. Allocation X INTERVENTIONS EMDR METHODS TAU ASSESSMENTS This is a multicenter phase II rater-blinded randomized FAST X X X controlled trial, phase II, with two parallel branches, EMDR and TAU, of patients diagnosed with SUD who have a comorbid PRISM, Psychiatric Research Interview for Substance and Mental Disorders; MINI, history of psychological trauma, even if they do not currently Mini-International Neuropsychiatric Interview; HDRS, Hamilton Depression Rating Scale; meet DSM-V criteria for PTSD. The patients will be matched YMRS, Young’s scale for the evaluation of the Mania; BPRS, Brief Scale of Psychiatric by site, age, sex, and diagnosis. One group will consist of TAU Evaluation; TLFB, Timeline Followback; SDS, Dependence severity scale; EVA, Analog visual scale; CTQ, Childhood Trauma Questionnaire; H-RLSI, The Holmes-Rahe Life plus 20 individual 60-min EMDR sessions over a duration of 6 Stress Inventory; EGEP, Global Assessment of Posttraumatic Stress Questionnaire; IES-R, months, while the other group will receive TAU only. Patients Scale of the impact of events reviewed; DES, Scale of Dissociative Experiences; EMDR, will be evaluated at baseline (T0), 3 months (T1: only substance Eye movement desensitization and reprocessing therapy; TAU, Treatment as usual; FAST, Functioning Assessment Short Test. use-related symptoms), post-treatment at 6 months (T2), and at 12 months as follow-up (T3) (see Table 1). Clinical raters A recent Cochrane review into the efficacy of CBT- carrying out evaluations will be blind to the participants’ research based therapies for comorbid SUD and PTSD found that condition. Patients will not be blind to treatment as a sham preliminary evidence showed that trauma-focused therapy alternative to EMDR therapy is impossible due to its use of delivered alongside SUD therapy could improve PTSD symptoms bilateral stimulation. at short- and long-term, and SUD symptoms at long-term, The study has been approved by the Ethic Committees compared to treatment as usual. They concluded that more of the Hospital Benito Menni, Germanes Hospitalàries del research is needed on trauma-focused therapies for this Sagrat Cor de Jesús (PR-2018-04), and the IMIM, Parc de population, but that there is very little evidence to support Salut Mar (2017/7615/I). All participants will sign informed individual therapies not focused on trauma (16). consent prior to enrollment. Details of the trial design can One leading trauma-focused treatment is Eye Movement be also gathered from Supplementary Material (Standard Desensitization and Reprocessing (EMDR) therapy, Protocol Items: Recommendations for Interventional Trials recommended as a first-line PTSD treatment by international [SPIRIT] Checklist). bodies such as the American Psychiatric Association (APA) This is a multicenter phase II collaborative project will (17) and the World Health Organization (WHO) (18). Initial involve the participation of five different centers from the studies have shown the potential for EMDR to be applied to Barcelona catchment area, Spain: four outpatient addiction the SUD population. Until nowadays, there are three published clinics pertaining to the Institute of Neuropsychiatry and trials in SUD and EMDR: two small randomized controlled Addictions (INAD), Parc de Salut Mar, and a fifth pertaining trials (RCT) and one non-randomized controlled trial of EMDR to the Hospital Benito Menni, in Sant Boi de Llobregat. vs. treatment as usual (TAU) in patients with SUD (19–21). Both institutions involved are centers of reference in mental Frontiers in Psychiatry | www.frontiersin.org 3 March 2019 | Volume 10 | Article 108 Valiente-Gómez et al. EMDR in Traumatized SUD Patients health treatment and research, facilitating the recruitment and interview (Psychiatric Research Interview for Substance and development of the project. EMDR therapists have extensive Mental Disorders; PRISM) (42) and a review of case notes. experience in EMDR protocols and SUD. All participating raters Inclusion criteria are: (1) aged 18–65, (2) outpatient, and will be trained in the blind-to-treatment application of all (3) presence of one or more traumatic events currently causing clinical assessments. trauma-associated symptoms (Impact of Events Scale-Revised, IES-R > 0) and Subjective Disturbance Unit (SUD) > 5, that Study Outcomes assesses subjective disturbance in a scale between 0 and 10, but The primary outcome is to test the efficacy of EMDR therapy in it is not necessary that traumatic events meet DSM-5 criteria reducing the severity of substance use in patients with comorbid for PTSD. SUD and a history of psychological trauma, irrespective of Exclusion criteria are: (1) presence of organic brain diseases, whether the patient meets DSM-V PTSD criteria. Changes from (2) presence of acute suicidal ideation, (3) having received a baseline in the severity of substance use are measured by the trauma-focused therapy or attended psychotherapeutic groups Timeline Follow Back (TLFB) (31), the Severity of Dependence for survivors of violence within the last 2 years, or (4) acute Scale (SDS) (32), and the Visual Analog Scale (VAS). episode of comorbid psychiatric disorder. The secondary outcome is to test the efficacy of EMDR in improving trauma-related psychological symptoms, Randomization Procedure psychopathological symptoms, and the overall functionality Clinical trials use randomization to balance confounding factors in SUD patients with a history of psychological trauma. (to an uncontrolled extent) and to conceal allocation. However, Changes in psychological trauma and dissociative symptoms are complete randomization in small to moderate studies may fail measured using the Global Assessment of Posttraumatic Stress to balance groups, severely affecting inference. To overcome Questionnaire (EGEP-5) (33), the Impact of Event Scale-Revised this issue Efron (43) introduced the biased coin methods, (IES-R) (34), and the Dissociative Experiences Scale (DES) (35), which randomize each patient to one or the other group respectively. The type and severity of traumatic experiences are with a probability or another with the aim of increasing measured using the Childhood Trauma Questionnaire (CTQ) the balance of known confounding factors. Importantly, these (36) and The Holmes-Rahe Life Stress Inventory (37). Changes methods still randomize each of the patients, thus balancing in psychopathological symptoms are measured by the Hamilton the unknown confounding factors (to the uncontrolled extend Depression Rating Scale (HDRS) (38), Young Mania Rating that complete randomization does) and concealing allocation Scale (YMRS) (39), and the Brief Psychiatric Rating Scale (BPRS) (44). Non-deterministic dynamic allocation designs, such as (40). Changes in overall functioning will be measured using the the biased coin methods, were included in international Functioning Assessment Short Test (FAST) (41). 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. Hypotheses URL: https://www.ich.org/products/guidelines/efficacy/efficacy- 1. Patients in the EMDR group will show a reduction in the level single/article/statistical-principles-for-clinical-trials.html). and severity of substance use-related symptoms as compared In this trial, all patients meeting the inclusion criteria will to the TAU group. receive the baseline (T0) assessment. After T0, participants will 2. Patients in the EMDR group will show a reduction in the be assigned to the EMDR or TAU group following a biased number of relapses as compared to the TAU group. coin procedure (46): (1) the first two patients will be randomly 3. Patients in the EMDR group will show a reduction in the allocated to EMDR with p = 0.5, (2) the next patient will be severity of trauma-related symptoms as compared to the allocated as follows: (b1) if one group already includes at least two TAU group. more patients than the other group, the patient will be randomly 4. There will be a reduction in depressive symptoms associated allocated to EMDR with p = 0.8 is this is the smallest group and with a comorbid psychiatric disorder in the EMDR group as with p = 0.2 if it is the largest group, (b2) otherwise, we will first compared to the TAU group. simulate that the patient is allocated to EMDR and calculate the 5. There will be a reduction in (hypo) manic symptoms sum of the between-group square standardized differences in site, associated with a comorbid psychiatric disorder in the EMDR age, sex, diagnosis (dual vs. not dual) and number of substances group as compared to the TAU group. consumed during the month before the randomization (none. 6. There will be a reduction in general psychopathology one or more than one), we will then simulate that the patient is symptoms associated with psychiatric comorbidity in the allocated to TAU and recalculate the sum, and finally randomly EMDR group as compared to the TAU group. allocate the patient to EMDR with p = 0.8 if this was associated 7. Patients in the EMDR group will show an improvement in to the smallest sum and with p = 0.2 if not. For example, if functioning as compared to the TAU group. we had already included 10 patients to the EMDR group and 8 patients to the TAU group, the 19th patient would be randomly Study Participants allocated with p = 0.2 for EMDR and p = 0.8 for TAU. If The study sample will consist of 142 outpatients fulfilling the he/she was allocated to TAU, for the 20th patient we would criteria of the Diagnostic and Statistical Manual of Mental calculate the above sum of covariates after simulating that the Disorders, fifth edition (DSM-5), for SUD based on a clinical he/she is allocated to EMDR and after simulating that he/she is Frontiers in Psychiatry | www.frontiersin.org 4 March 2019 | Volume 10 | Article 108 Valiente-Gómez et al. EMDR in Traumatized SUD Patients allocated to TAU, and if the sum of the EMDR simulation was Hase (48) to treat both trauma-related symptoms and SUD larger than the sum of the TAU simulation, we would randomly symptoms, respectively. allocate the 20th patient with p = 0.2 for EMDR and p = 0.8 The current standard protocol includes eight phases, briefly for TAU. Following this procedure, the final groups should be described below: balanced in size and matched in site, age, sex and diagnosis. All 1. Patient history: The therapist assesses the patient’s attachment steps of the randomization process will be automatically carried history, medical history, physical problems and identifies out by an independent researcher in a central location using a traumatic events and their relationship to current symptoms. computer program. A treatment plan is developed. Computation of Sample Size 2. Patient preparation: A safe therapeutic environment is The study aims to assess the efficacy of EMDR therapy compared established, the theory and processes of EMDR are explained, with TAU, in inpatients with SUD, in terms of a reduction in and the therapist may try out different modalities of substance use, a reduction in symptoms associated with craving bilateral stimulation, including eye movements, where the and associated symptoms of anxiety and depression, and an patient’s eyes follow the therapist’s fingers moving in improvement in functioning. horizontally or diagonally across their field of vision. We aim for the study to be able to detect medium-sized While eye movements are generally recommended, if differences in the pre-post changes between groups with an they are not well-tolerated, another modality, such as 80% statistical power. Given that there are no previous studies tapping the back of the patient’s hands or auditory tones, that report the variability of these changes, we have defined may be used. medium-sized differences as those with a medium effect size (d 3. Patient assessment: The therapist helps the patient to bring the = 0.5). With the function power.t.test from R (http: //www.r- traumatic memory to mind and identify associated cognitions, project.org/), we have calculated that the number of patients emotions and physical sensations. The patient identifies the required to detect medium-sized differences (d = 0.5) with image which represents the worst part of the traumatic a statistical power of 80% is n = 64 per intervention group memory and an associated negative cognition, and is helped to (two groups, total n = 128). Assuming a loss percentage of identify a positive cognition to replace this. Finally, the patient approximately 10% of the patients in the study, it would be identifies the distress level they experience upon bringing necessary to recruit approximately 142 patients, 71 for each the traumatic experience and negative cognition to mind. intervention branch. Distress is measured using the Subjective Units of Disturbance Scale (SUD), scored from 0 (minimum disturbance) to 10 Statistical Analysis (maximum disturbance). The distribution of socio-demographic and clinical 4. Memory desensitization: The patient brings to mind the characteristics between groups in the baseline state will be traumatic image, negative cognition and associated emotion summarized using descriptive statistics. The change in clinical and notices any physical discomfort generated in the present and functional variables with regard to baseline evaluation moment. The patient focuses on this material and a 30–40 s at strategic points of the intervention will be analyzed using set of bilateral stimulation is applied, during which the patient mixed-effects repeated-measures linear models, including as is instructed to observe what is happening without judgment, fixed factors time, treatment conditions and their interactions, and afterwards express what occurred. The therapist asks and as a random factor the site. The differences between groups, the patient to focus on new material without comment, for the categorical variables and main clinics, will be analyzed assessment, or interpretation. This is repeated until no new by adding covariates to the models. Those covariates that are material arises and the traumatic memory generates no statistically significant may be added in the same model to distress (SUD = 0 or 1). determine which covariates are best predictors of the response. 5. Installing the positive cognition: The patient brings the The size of the effects will be estimated using the g of Hedges or positive cognition and original experience to mind. Further the r of Pearson. It will be corrected for multiple comparisons. sets of bilateral stimulation are applied, causing the patient to The statistical software used for the analysis will be the latest link the positive cognition with the original memory, until the available version of R. We will conduct an intention to treat positive belief is fully installed. (ITT) analysis. The “Last Observation Carried Forward” (LOCF) 6. Body scan: The therapist asks the patient to close their eyes method will be used for losses of follow-up. 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 STEPWISE PROCEDURES bilateral stimulation until it disappears. If the sensation is Intervention positive, it will be reinforced with short sets (10–12 s) of EMDR bilateral stimulation. Patients in the EMDR condition will receive 20 individual 7. Closure: The therapist explains possible effects following the sessions of 60 min each, using the standard EMDR therapy session, such as new insights, thoughts, memories, and even protocol developed by Shapiro (47) and a further specific dreams or nightmares, and offers recommendations about protocol for SUD, the CRAVEX protocol, developed by what to do in each case. Frontiers in Psychiatry | www.frontiersin.org 5 March 2019 | Volume 10 | Article 108 Valiente-Gómez et al. EMDR in Traumatized SUD Patients TABLE 2 | Measurements to evaluate consumption symptoms. TABLE 3 | Measurements to evaluate psychological trauma symptoms. Clinical Measurement T0 T1 T2 T3 Clinical Measurement T0 T1 T2 T3 variable interview/ variable interview/ Self-report Baseline Mid- Post- Post- Self-report Baseline Mid- Post- Post- treatment treatment treatment treatment treatment treatment 6 months 12 months 6 months 12 months Timeline TLFB x x x x Childhood T CTQ x Dependence SDS x x x x PTSD EGEP x x x Craving EVA x x x x Traumatic H-RLSI x events TLFB, Timeline Followback Questionnaire; SDS, Severity of Dependence Scale; EVA, Trauma’s IES-R x x x Visual Analog Scale. impact Dissociation DES x x x 8. Reevaluation: The therapist assesses the patient’s experiences Childhood T, Childhood trauma; CTQ, Childhood Trauma Questionnaire; PTSD, since the previous session and reevaluates the traumatic post-traumatic stress disorder; EGEP, Global Assessment of Posttraumatic Stress memory to confirm functional processing. If the memory has Questionnaire; H-RLSI, The Holmes-Rahe Life Stress Inventory; IES-R, Impact Event been desensitized, the therapist selects a new target of either Scale; DES, Scale of Dissociative Experiences. another traumatic memory, a current trigger of distress, or a potentially threatening future event. The CRAVEX protocol (48) will also be applied to process during the acute phase. In the case of relapse during follow- craving. This protocol focuses on the concept of addiction up, patients will be maintained in the trial to obtain maximum memory (AM), in which the biological effect of the drugs has information on the course of the illness. a serious impact on the brain comparable to trauma, which leads to the formation of a maladaptive implicit memory which MATERIALS AND EQUIPMENT if reprocessed can decrease cravings or urges, and potentially promote access to the brain channels connected to the initial Instruments and Measures reasons the individual became addicted (49). Instead of SUD, The consumption of substances will be quantified using the the CRAVEX protocol uses Level of Urge (LOU), with a scale of following tools (see Table 2): 0 (no urge) to 10 (worst urge imaginable), referring to the urge 1. Timeline Followback Questionnaire (TLFB): The TLFB (31) to consume the substance. As in the standard protocol, positive is a retrospective calendar-based measure of daily substance and negative cognitions, emotions and physical sensations are use, initially developed to obtain self-reports of alcohol use but identified but, in this case, they are associated with the last time nowadays also used for other substances. that the subject consumed the drug. Bilateral stimulation is used 2. Severity of Dependence Scale (SDS): The SDS (32) is a 5- until the AM is desensitized, and finally the positive cognition item questionnaire indicating the degree of dependence on is installed. different types of drugs. Each item is scored on a 4-point scale (0–3) and summed to create a total score. Higher scores TAU indicate greater dependence. All patients included in this study will participate in the TAU 3. Visual Analog Scale (VAS): A self-report scale to measure condition, comprising the standard care package offered by the craving intensity, classically used to measure pain intensity. Drug and Alcohol Outpatient Unit. This is a multidisciplinary It ranges from 0 to 10: the higher the score, the greater the unit with doctors, psychiatrists, clinical psychologists, nurses, and craving severity. social workers on the staff. An individual care plan is drawn up depending on individual needs and may include follow-up Trauma-related symptoms will be evaluated using the tools listed psychiatric visits to evaluate clinical status and, if necessary, in Table 3: readjust pharmacological treatment, and psychological visits to 1. Childhood Trauma Questionnaire (CTQ): The CTQ (36), assess and detect risk situations and prevent relapses using a non- Spanish validation (50), is a self-administered 28-item scale trauma focused CBT. In no case will psychological treatment developed as a screening tool for histories of childhood abuse focus on PTSD. TAU also includes nurse visits for health and and neglect, with 5 subscales: emotional, physical or sexual self-care habits and nurses may also carry out abstinence controls. abuse, and emotional or physical neglect. A 5-point Likert scale is used for the responses, ranging from “Never True” to Dropouts and Follow-Up “Very Often True.” If a participant requires an inpatient stay due to substance misuse 2. Global Assessment of Posttraumatic Stress or an acute episode of a comorbid disorder during the 6-month Questionnaire(EGEP-5): The EGEP-5 (51) is a clinical intervention period, the patient will be excluded from the trial interview for the diagnosis of PTSD, both current and in and considered as dropout because the hospital admission will the past, based on DSM-V criteria. This scale contains three mean the patient cannot continue with the EMDR psychotherapy sections: events, symptoms and functioning. Frontiers in Psychiatry | www.frontiersin.org 6 March 2019 | Volume 10 | Article 108 Valiente-Gómez et al. EMDR in Traumatized SUD Patients 3. The Holmes-Rahe Life Stress Inventory (37); Spanish TABLE 4 | Measurements to evaluate clinical symptoms and functionality. validation (52): this is a scale assessing the frequency of Clinical Measurement T0 T1 T2 T3 43 common stressful life events over the past 12 months, variable interview/ providing a standardized measure of their impact (53). Scores Self-report Baseline Mid- Post- Post- below 150 reflect low levels of stress, scores between 150 treatment treatment treatment and 299 represent a 50% risk of a stress-related illness in 6 months 12 months the near future and scores above 300 represent an 80% risk Diagnosis PRISM x (37), although each individual’s reactions to stress and coping Diagnosis MINI x ability must be considered. Mania YMRS x x x 4. Impact of Event Scale-Revised (IES-R): The IES-R (54), Depression HDRS x x x Spanish validation (55), is a 22-item self-report measure of subjective distress over the previous 7 days related to a specific Psychiatric S. BPRS x x x stressful life event. Items correspond directly to 14 of the 17 Functionality FAST x x x DSM-IV symptoms of PTSD. Items are rated on a 5-point PRISM, Psychiatric Research Interview for Substance and Mental Disorders; MINI, scale ranging from 0 and 4, yielding a total score ranging Mini-International Neuropsychiatric Interview; YMRS, Young Mania Rating Scale; HDRS, from 0 to 88, with subscale scores for Intrusion, Avoidance, Hamilton Depression Rating Scale; Psychiatric S, Psychiatric symptoms; BPRS, Brief Scale of Psychiatric Evaluation, FAST, Functioning Assessment Short Test; Psychiatric and Hyperarousal. S, Psychiatric symptoms. 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 a 4-point scale and summed to obtain a global score normal to pathological, with an overall mean score ranging ranging from 0 to 72. The higher scores indicate poorer from 0 to 100 (57). functional status. Diagnosis, clinical symptoms, and functioning will be assessed using the following instruments (see Table 4): Anticipated Results 1. The clinical diagnosis of SUD will be made according to The expected results of the current study will provide DSM-5 criteria, using the Spanish version of the clinical evidence of whether EMDR therapy is effective in reducing interview Psychiatric Research Interview for Substance and symptoms related to substance use, trauma-related and clinical Mental Disorders (PRISM) (42). symptoms in outpatients with SUD and a comorbid history of 2. Mini-International Neuropsychiatric Interview (MINI): A psychological trauma. Spanish-validated brief structured diagnostic interview to assess the 17 most common psychiatric disorders as per DSM- DISCUSSION IV criteria (58). 3. Hamilton Depression Rating Scale (HDRS): The HDRS (38), In recent years, the third-generation psychotherapies such as Spanish validation (59), is a 17-item hetero-administered scale EMDR, which emerged in the 90s within the tradition of designed to be used in patients previously diagnosed with behavioral therapy (62), have gained considerable interest in depression, to quantitatively assess the severity of and changes both social and scientific fields due to their ability to integrate in depressive symptoms. Each item has three or five possible cognitive, emotional and behavioral components within the answers, scored 0–2 or 0–4, respectively. Total scores range same psychotherapeutic approach, processing adverse life events from 0 to 52. and therefore ameliorating associated psychiatric symptoms. To 4. Young Mania Rating Scale (YMRS): The YMRS (39), Spanish date, preliminary evidence exists suggesting EMDR therapy is validation (60), is an 11-item hetero-administered scale which efficacious in SUD patients, thanks to previous studies done quantifies the severity of manic and hypomanic episodes. in that population (20, 63). In a more recent publication (21), Four items are given more weight to compensate for a quasi-experimental study of 40 SUD outpatients found that poor cooperation from severely ill patients and are graded EMDR as an add-on treatment had a pronounced effect in on a 0–8 scale (irritability, speech, thought content and reducing post-traumatic and dissociative symptoms and also disruptive/aggressive behavior), while the remaining seven caused a significant improvement in the global severity of items are graded on a 0–4 scale. psychiatric symptoms. The aim of our trial is to provide further 5. Brief Psychiatric Rating Scale (BPRS): The BPRS (40), Spanish evidence of a positive effect of EMDR in this difficult-to- validation (61), is an 18-item hetero-administered scale treat population in a larger RCT. In our study, we aim to measuring psychopathological changes. It includes anxious, treat real-world dual patients, with a wide range of substances affective and psychotic symptoms, with each rated on a used and varied comorbid psychiatric and somatic illnesses severity scale of 1–7. (except neurological disorders). In contrast to prior studies, 6. Functioning Assessment Short Test (FAST): The FAST (41) we also include a year follow-up to test whether possible is a 24-item instrument to evaluate functioning in six areas: improvements are maintained. With results from a large RCT, autonomy, occupational functioning, cognitive functioning, we aim to promote trauma-oriented therapies in patients with finances, relationships and leisure. Each item is rated on dual disorders. Although it has been shown that there is a Frontiers in Psychiatry | www.frontiersin.org 7 March 2019 | Volume 10 | Article 108 Valiente-Gómez et al. EMDR in Traumatized SUD Patients clear association between PTSD and addiction (64), most mental be changed as far as possible, once patients have been health care programs do not offer trauma-oriented therapies stabilized. Moreover, it should be noted that our center for patients with SUD. To understand better the relationship has extensive experience in the treatment of SUD and uses between the presence of traumatic events and the diagnosis standardized treatment protocols, which will also help limit this of SUD, we will study several variables before, during and potential issue. after treatment. We will assess variables of clinical severity, consumption and overall functioning with specific and validated AUTHOR CONTRIBUTIONS instruments. In short, the potential of this study is to demonstrate the effectiveness and safety of EMDR in dual disorders. Along BA and MT had the idea for the project. AV-G, AM-A, LB, these lines, we could be closer to establishing an effective new MR-M, and BA contributed to the design of the study. AV-G psychological treatment for these patients in addition to the wrote the first draft of the manuscript, with supervision from standard treatment. In this way, the impact of this trial is to AM-A, BH, and BA (primary supervisor). JR will carry out improve the clinical evolution and prognosis and to reduce the randomization of patients and the statistical analyses. JR, hospital admissions in SUD patients. LB, BH, WL, MR-M, VP, and MT contributed to the revisions and modifications of the manuscript and all have approved the LIMITATIONS final version. A limitation of this study is the inclusion of heterogeneous FUNDING patients with various psychiatric diagnoses, including SUD with somatic and other psychiatric comorbidities. This trial This work is supported by a PERIS Grant (SLT006/17/00038) has been specifically designed as a pragmatic real-world study from the Catalonia Government. The sources of funding have no with few exclusion criteria. We believe this limitation can influence on the design and the conducting and the reporting of be sufficiently controlled by matching samples in both arms the trial. and by the fact that the main common clinical underlying variable of all patients is a comorbid psychological trauma. SUPPLEMENTARY MATERIAL Furthermore, the lack of control regarding drug treatment is a potential source of bias. To partly overcome this The Supplementary Material for this article can be found limitation, the “pharmacological treatment” variable will be online at: https://www.frontiersin.org/articles/10.3389/fpsyt. taken into account and the treatment regimen should not 2019.00108/full#supplementary-material REFERENCES the gain in addition to PTSD symptoms? Psychiatry Res. (2015) 226:328–32. doi: 10.1016/j.psychres.2015.01.014 1. Tirado-otálvaro AF. El consumo de drogas en el debate de la 9. van der Kolk BA, Brown P, van der Hart O. Pierre Janet on post- salud pública. Saúde Públ. (2016) 32:1–11. doi: 10.1590/0102-311 traumatic stress. J Trauma Stress. (1989) 2:365–78. doi: 10.1007/B X00177215 F00974596 2. Hughes K, Bellis MA, Hardcastle KA, Sethi D, Butchart A, Mikton C, 10. American Psychiatric Association. Diagnostic and Statistical et al. The effect of multiple adverse childhood experiences on health: a Manual of Mental Disorders. 5th ed. Washington, DC. (2013). systematic review and meta-analysis. Lancet Public Heal. (2017) 2:e356–66. doi: 10.1176/appi.books.9780890425596.744053 doi: 10.1016/S2468-2667(17)30118-4 11. Gradus JL. Prevalence and prognosis of stress disorders: a review 3. Dragan M, Lis-Turlejska M. Prevalence of posttraumatic stress disorder of the epidemiologic literature. Clin Epidemiol. (2017) 9:251–60. in alcohol dependent patients in Poland. Addict Behav. (2007) 32:902–11. doi: 10.2147/CLEP.S106250 doi: 10.1016/j.addbeh.2006.06.025 12. Mauritz MW, Goossens PJJ, Draijer N, van Achterberg T. Prevalence 4. Driessen M, Schulte S, Luedecke C, Schaefer I, Sutmann F, Ohlmeier of interpersonal trauma exposure and trauma-related disorders in severe M, et al. Trauma and PTSD in patients with alcohol, drug, or dual mental illness. Eur J Psychotraumatol. (2013) 4:19985. doi: 10.3402/ejpt.v dependence: a multi-center study. Alcohol Clin Exp Res. (2008) 32:481–8. 4i0.19985 doi: 10.1111/j.1530-0277.2007.00591.x 13. Álvarez MJ, Masramon H, Peña C, Pont M, Gourdier C, Roura-Poch 5. Gielen N, Havermans RC, Tekelenburg M, Jansen A. Prevalence of post- P, et al. Cumulative effects of childhood traumas: polytraumatization, traumatic stress disorder among patients with substance use disorder: it is dissociation, and schizophrenia. Community Ment Health J. (2014) 51:54–62. higher than clinicians think it is. Eur J Psychotraumatol. (2012) 3:17734. doi: 10.1007/s10597-014-9755-2 doi: 10.3402/ejpt.v3i0.17734 14. Grundmann J, Lincoln TM, Lüdecke D, Bong S, Schulte B, Verthein 6. Proescholdt MG, Müller SE, Vogel M, Lang U, Wiesbeck GA, Breit W, et al. U, et al. Traumatic experiences, revictimization and posttraumatic Early screening for posttraumatic stress disorder in inpatient detoxification stress disorder in german inpatients treated for alcohol dependence. and motivation treatment: results and consequences. Eur Addict Res. (2018) Subst Use Misuse. (2018) 53:677–85. doi: 10.1080/10826084.2017. 24:128–36. doi: 10.1159/000490382 1361997 7. Reynolds M, Mezey G, Chapman M, Wheeler M, Drummond C, 15. Berardis D, Marini S, Serroni N, Iasevoli F, Tomasetti C, Bartolomeis A, Baldacchino A. Co-morbid post-traumatic stress disorder in a substance et al. Targeting the noradrenergic system in posttraumatic stress disorder: misusing clinical population. Drug Alcohol Depend. (2005) 77:251–8. a systematic review and meta-analysis of prazosin trials. Curr Drug Targets. doi: 10.1016/j.drugalcdep.2004.08.017 (2015) 16:1094–106. doi: 10.2174/1389450116666150506114108 8. Kok T, de Haan H, van der Meer M, Najavits L, de Jong C. Assessing traumatic 16. Roberts NP, Roberts PA, Jones N, Bisson JI. Psychological experiences in screening for PTSD in substance use disorder patients: what is therapies for post-traumatic stress disorder and comorbid substance Frontiers in Psychiatry | www.frontiersin.org 8 March 2019 | Volume 10 | Article 108 Valiente-Gómez et al. EMDR in Traumatized SUD Patients use disorder. Cochrane Database Syst Rev. (2016) 4:CD010204. 36. Bernstein D, Fink L, Handelsman L, Lovejoy M, Wenzel K, Sapareto E, et al. doi: 10.1002/14651858.CD010204.pub2 Initial reliability and validity of a new retrospective measure of child ab...: 17. American Psychiatric Association. Practice Guideline for the Treatment EBSCOhost. Am J Psychiatry. (1994) 151:1132–6. doi: 10.1176/ajp.151.8.1132 of Patients with Acute Stress Disorder and Posttraumatic Stress Disorder. 37. Holmes TH, Rahe RH. The social readjustment rating scale. J Psychosom Res. Washington: Masson (2004). (1967) 11:213–8. doi: 10.1016/0022-3999(67)90010-4 18. World Health Organisation. Guidelines for the Management of Conditions 38. Hamilton MC. Hamilton Depression Rating Scale (HAM-D). Redloc. (1960) Specifically Related to Stress. Geneva: WHO (2013). 23:56–62. doi: 10.1111/j.1600-0447.1986.tb10903.x 19. Hase M, Schallmayer S, Sack M. EMDR reprocessing of the addiction memory: 39. Young RC, Biggs JT, Ziegler VE, Meyer DA. A rating scale for mania: pretreatment, posttreatment, and 1-month follow-up. J EMDR Pract Res. reliability, validity and sensitivity. Br J Psychiatry. (1978) 133:429–35. (2008) 2:170–9. doi: 10.1891/1933-3196.2.3.170 doi: 10.1192/bjp.133.5.429 20. Perez-Dandieu B, Tapia G. Treating trauma in addiction with 40. Overall JE, Gorham DR. The brief psychiatric rating scale. Psychol Rep. (1962) EMDR: a pilot study. J Psychoactive Drugs. (2014) 46:303–9. 10:799–812. doi: 10.2466/pr0.1962.10.3.799 doi: 10.1080/02791072.2014.921744 41. Rosa AR, Sánchez-Moreno J, Martínez-Aran A, Salamero M, Torrent C, 21. Carletto S, Oliva F, Barnato M, Antonelli T, Cardia A, Mazzaferro P, Reinares M, et al. Validity and reliability of the Functioning Assessment Short et al. EMDR as add-on treatment for psychiatric and traumatic symptoms Test (FAST) in bipolar disorder. Clin Pract Epidemiol Ment Heal. (2007) 3:5. in patients with substance use disorder. Front Psychol. (2017) 8:2333. doi: 10.1186/1745-0179-3-5 doi: 10.3389/fpsyg.2017.02333 42. Torrens M, Serrano D, Astals M, Pérez-Domínguez G, Martín-Santos R. 22. Schäfer I, Chuey-Ferrer L, Hofmann A, Lieberman P, Mainusch G, Lotzin A. Diagnosing comorbid psychiatric disorders in substance abusers: validity of Effectiveness of EMDR in patients with substance use disorder and comorbid the Spanish versions of the psychiatric research interview for substance and PTSD: study protocol for a randomized controlled trial. BMC Psychiatry. mental disorders and the structured clinical interview for DSM-IV. Am J (2017) 17:95. doi: 10.1186/s12888-017-1255-9 Psychiatry. (2004) 161:1231–7. doi: 10.1176/appi.ajp.161.7.1231 23. Valiente-Gómez A, Moreno-Alcázar A, Treen D, Cedrón C, Colom F, Pérez 43. Efron B. Forcing a sequential experiment to be balanced. Biometrika. (1971) V, et al. EMDR beyond PTSD: a systematic literature review. Front Psychol. 58:403–17. doi: 10.1093/biomet/58.3.403 (2017) 8:1668. doi: 10.3389/fpsyg.2017.01668 44. Antognini AB, Rosenberger WF, Wang Y, Zagoraiou M. Exact optimum 24. Novo P, Landin-Romero R, Radua J, Vicens V, Fernandez I, Garcia F, et al. Eye coin bias in Efron’s randomization procedure. Stat Med. (2015) 34:3760–8. movement desensitization and reprocessing therapy in subsyndromal bipolar doi: 10.1002/sim.6576 patients with a history of traumatic events: a randomized, controlled pilot- 45. E9 Statistical Principles for Clinical Trials. The International Council for study. Psychiatry Res. (2014) 219:122–8. doi: 10.1016/j.psychres.2014.05.012 Harmonisation of Technical Requirements for Pharmaceuticals for Human 25. De Bont PAJM, Van Den Berg DPG, Van Der Vleugel BM, De Roos C, De Use (ICH). (1998). Available online at: https://www.ich.org/fileadmin/Public_ Jongh A, Van Der Gaag M, et al. Prolonged exposure and EMDR for PTSD v. Web_Site/ICH_Products/Guidelines/Efficacy/E9/Step4/E9_Guideline.pdf a PTSD waiting-list condition: effects on symptoms of psychosis, depression 46. Chambless DL, Hollon SD. Defining empirically supported therapies. J and social functioning in patients with chronic psychotic disorders. Psychol Consult Clin Psychol. (1998) 66:7–18. doi: 10.1037/0022-006X.66.1.7 Med. (2016) 46:2411–21. doi: 10.1017/S0033291716001094 47. Shapiro F. Eye Movement Desensitization and Reprocessing: Basic Principles, 26. Behnammoghadam M, Alamdari AK, Behnammoghadam A, Darban F. Effect Protocols, and Procedures. 2nd ed. (2001). Available online at: http://proxy. of eye movement desensitization and reprocessing (EMDR) on depression in library.nd.edu/login?url=http://search.proquest.com/docview/619595584? patients with myocardial infarction (MI). Glob J Health Sci. (2015) 7:258–62. accountid=12874 LA - English doi: 10.5539/gjhs.v7n6p258 48. Hase M. CravEx: An EMDR Approach to Treat Substance Abuse and 27. Hase M, Balmaceda UM, Hase A, Lehnung M, Tumani V, Huchzermeier C, Addiction. (2010). Available online at: http://ovidsp.ovid.com/ovidweb.cgi?T= et al. Eye movement desensitization and reprocessing (EMDR) therapy in the JS&PAGE=reference&D=psyc6&NEWS=N&AN=2009-16776-037 treatment of depression: a matched pairs study in an inpatient setting. Brain 49. O’Brien JM, Abel NJ. EMDR, addictions, and the stages of change: Behav. (2015) 5:1–9. doi: 10.1002/brb3.342 a road map for intervention. J EMDR Pract Res.. (2011) 5:121–30. 28. Doering S, Ohlmeier MC, de Jongh A, Hofmann A, Bisping V. Efficacy of a doi: 10.1891/1933-3196.5.3.121 trauma-focused treatment approach for dental phobia: a randomized clinical 50. Hernandez A, Gallardo-Pujol D, Pereda N, Arntz A, Bernstein DP, trial. Eur J Oral Sci. (2013) 121:584–93. doi: 10.1111/eos.12090 Gaviria AM, et al. Initial validation of the Spanish childhood trauma 29. Feske U, Goldstein AJ. Eye movement desensitization and reprocessing questionnaire-short form: factor structure, reliability and association with treatment for panic disorder: a controlled outcome and partial parenting. J Interpers Violence. (2013) 28:1498–518. doi: 10.1177/08862 dismantling study. J Consult Clin Psychol. (1997) 65:1026–35. 60512468240 doi: 10.1037/0022-006X.65.6.1026 51. Crespo M, Gómez M. Posttraumatic stress assessment: introducing the global 30. Nazari H, Momeni N, Jariani M, Tarrahi MJ. Comparison of eye assessment of posttraumatic stress questionnaire. Clín Salud. (2012) 23:25–41. movement desensitization and reprocessing with citalopram in treatment of doi: 10.5093/cl2012a4 obsessive-compulsive disorder. Int J Psychiatry Clin Pract. (2011) 15:270–4. 52. González de Rivera JL, Morera Fumero A. La valoración de sucesos doi: 10.3109/13651501.2011.590210 vitales: adaptación española de la escala de Holmes y Rahe. Psiquis. 31. Sobell LC, Sobell MB. Timeline follow-back. In: Litten RZ, Allen JP, (1983) 4:7–11. editors. Measuring Alcohol Consumption: Psychosocial and Biological Methods. 53. Weber K, Giannakopoulos P, Herrmann FR, Bartolomei J, Digiorgio S, Totowa, NJ: Humana Press (1992). doi: 10.1007/978-1-4612-0357-5_3 Ortiz Chicherio N, et al. Stressful life events and neuroticism as predictors 32. Gossop M, Darke S, Griffiths P, Hando J, Powis B, Hall WSJ. The Severity of late-life versus early-life depression. Psychogeriatrics. (2013) 13:221–8. of Dependence Scale (SDS): psychometric properties of the SDS in English doi: 10.1111/psyg.12024 and Australian samples of heroin, cocaine and amphetamine users. Addiction. 54. Weiss DS, Marmar CR. The impact of event scale-revised. Int Cult Psychol Ser. (1995) 90:607–14. doi: 10.1046/j.1360-0443.1995.9056072.x (1997) 11:219–38. doi: 10.1007/978-0-387-70990-1_10 33. Crespo M, Gómez M. Development and validation of the Global Assessment 55. Costa Requena G, Gil Moncayo FL. Propiedades Psicométricas de la Escala of Post-traumatic Stress scale. J Vict. (2015) 1:55–71. doi: 10.12827/RVJV-2-03 Revisada del Impacto del Evento Estresante (IES-R) en una Muestra Espańola 34. Weiss DS, Marmar CR. The impact of event scale—revised. In: Wilson JP, de Pacientes con Cáncer. Análisis y Modificación Conducta. (2007) 33:311–32. Keane TM, editors. Assessing Psychological Trauma and PTSD. New York, NY: 56. Icaran E, Colom R, Orengo Garcia F. Dissociative Experiences: A Measurement Guilford Press (1997). p. 399–411. Scale. (1996). Available online at: http://ovidsp.ovid.com/ovidweb.cgi?T=JS& 35. Bernstein EM, Putnam FW. Development, reliability, and validity PAGE=reference&D=psyc3&NEWS=N&AN=1997-08030-004 of a dissociation scale. J Nerv Ment Dis. (1986) 174:727–35. 57. Nijenhuis ERS, Spinhoven P, VanDyck R, VanderHart O, Vanderlinden doi: 10.1097/00005053-198612000-00004 J. The development and psychometric characteristics of the somatoform Frontiers in Psychiatry | www.frontiersin.org 9 March 2019 | Volume 10 | Article 108 Valiente-Gómez et al. EMDR in Traumatized SUD Patients dissociation questionnaire (SDQ-20). J Nerv Ment Dis. (1996) 184:688–94. 64. Konkolÿ Thege B, Horwood L, Slater L, Tan MC, Hodgins DC, doi: 10.1097/00005053-199611000-00006 Wild TC. Relationship between interpersonal trauma exposure and 58. Bobes J. A Spanish validation study of the mini international addictive behaviors: a systematic review. BMC Psychiatry. (2017) 17:164. neuropsychiatric interview. Eur Psychiatry. (1998) 13:198s−9s. doi: 10.1186/s12888-017-1323-1 doi: 10.1016/S0924-9338(99)80240-5 59. Ramos-Brieva JA, Cordero-Villafafila A. A new validation of the Conflict of Interest Statement: BA is the Research Committee Chair of EMDR Hamilton Rating Scale for depression. J Psychiatr Res. (1988) 22:21–8. Europe and he has been invited as speaker to various national and international doi: 10.1016/0022-3956(88)90024-6 congresses of EMDR. WL is supervisor of the Spanish Association of EMDR. 60. Colom F, Vieta E, Martínez-Arán A, Garcia-Garcia M, Reinares M, Torrent C, et al. Spanish version of a scale for the assessment The remaining authors declare that the research was conducted in the absence of of mania: validity and reliability of the Young Mania Rating any commercial or financial relationships that could be construed as a potential Scale. Med Clin. (2002) 119:366–71. doi: 10.1016/S0025-7753(02) conflict of interest. 73419-2 61. Sánchez R, Ibáñez MAPA. Factor analysis and validation of a Spanish version Copyright © 2019 Valiente-Gómez, Moreno-Alcázar, Radua, Hogg, Blanco, Lupo, of the Brief Psychiatric Rating Scale in Colombia. Biomedica. (2005) 25:120–8. Pérez, Robles-Martínez, Torrens and Amann. This is an open-access article doi: 10.7705/biomedica.v25i1.1333 distributed under the terms of the Creative Commons Attribution License (CC BY). 62. Pérez-Álvarez M. Third-generation therapies: achievements and challenges. The use, distribution or reproduction in other forums is permitted, provided the Int J Clin Heal Psychol. (2012) 12:291–310. original author(s) and the copyright owner(s) are credited and that the original 63. Brown SH, Gilman SG, Goodman EG, Adler-Tapia R, Freng S. Integrated publication in this journal is cited, in accordance with accepted academic practice. trauma treatment in drug court: combining EMDR therapy and seeking safety. No use, distribution or reproduction is permitted which does not comply with these J EMDR Pract Res. (2015) 9:123–36. doi: 10.1891/1933-3196.9.3.123 terms. Frontiers in Psychiatry | www.frontiersin.org 10 March 2019 | Volume 10 | Article 108