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A Multicenter Phase II RCT to Compare the Effectiveness of EMDR Versus TAU in Patients With a First-Episode Psychosis and Psychological Trauma: A Protocol Design.

ABSTRACT: Background:Patients with a first episode psychosis (FEP) who are admitted for the first time to a psychiatric hospital frequently have experienced prior psychological trauma. Additionally, 40-80% develop posttraumatic stress symptoms, which are summarized as a post-psychotic post-traumatic syndrome (PPS). Eye Movement Desensitization and reprocessing (EMDR) therapy could be an effective psychotherapy to treat a PPS and prior psychological traumas in this population. Objectives:To assess if EMDR therapy leads to: 1) a reduction of relapses after intervention, 2) an improvement of trauma-related, psychotic and affective symptoms, 3) an improvement of overall functioning, and 4) an improvement in quality of life. Methods:This is a multicenter phase II rater-blinded randomized controlled trial in which 80 FEP patients with a history of psychological trauma will be randomly assigned to EMDR (n = 40) or to TAU (n = 40). Traumatic events will be measured by the Global Assessment of Posttraumatic Stress Questionnaire, the Cumulative Trauma Screening, the Impact of Event Scale-Revised, the Dissociative Experiences Scale, the Childhood Trauma Scale, the Holmes-Rahe Life Stress Inventory, and the Dissociative Experiences Questionnaire. Clinical symptomatology will be evaluated using the Suicide and Drug Consumption module of the International Neuropsychiatric Interview, Structured Clinical Interview for Positive and Negative Syndrome Scale, Young's Scale for Mania Evaluation, and Beck Depression II Questionnaire. Functionality will be assessed with the Global Assessment of Functioning and the Quality of Life with the Standardized Instrument developed by the EuroQol Group. The cognitive insight and adherence to the treatment will be assessed with the Beck Cognitive Insight Scale and the Drug Attitude Inventory. All variables will be measured at baseline, post-treatment and at 12-month follow-up. Conclusion:This study will provide evidence of whether EMDR therapy is effective in reducing trauma and clinical symptoms, reducing relapses and in improving functionality and quality of life in patients with FEP and a history of trauma. Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT03991377.

SUBMITTER: Valiente-Gomez A

PROVIDER: S-EPMC7014965 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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A Multicenter Phase II RCT to Compare the Effectiveness of EMDR Versus TAU in Patients With a First-Episode Psychosis and Psychological Trauma: A Protocol Design.

Valiente-Gómez Alicia A Pujol Nuria N Moreno-Alcázar Ana A Radua Joaquim J Monteagudo-Gimeno Eila E Gardoki-Souto Itxaso I Hogg Bridget B Álvarez Maria José MJ Safont Gemma G Lupo Walter W Pérez Victor V Amann Benedikt L BL

Frontiers in psychiatry 20200205

<h4>Background</h4>Patients with a first episode psychosis (FEP) who are admitted for the first time to a psychiatric hospital frequently have experienced prior psychological trauma. Additionally, 40-80% develop posttraumatic stress symptoms, which are summarized as a post-psychotic post-traumatic syndrome (PPS). Eye Movement Desensitization and reprocessing (EMDR) therapy could be an effective psychotherapy to treat a PPS and prior psychological traumas in this population.<h4>Objectives</h4>To ...[more]

PMID: 32116827

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Project description:Among the different therapeutic alternatives for post-traumatic stress disorder (PTSD), Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) and Eye Movement Desensitization and Reprocessing (EMDR) Therapy have shown promising results in helping patients cope with PTSD symptoms. However, given the different theoretical and methodological substrate of TF-CBT and EMDR, a potentially different impact on the brain for the two interventions could be hypothesized, as well as an interaction between trauma-specific PTSD symptomatology and response to a given psychotherapy. In this study, we monitored psychological and spontaneous functional connectivity fMRI patterns in two groups of PTSD patients who suffered by the same traumatic event (i.e., natural disaster), before and after a cycle of psychotherapy sessions based on TF-CBT and EMDR. Thirty-seven (37) PTSD patients were enrolled from a larger sample of people exposed to a single, acute psychological stress (i.e., 2002 earthquake in San Giuliano di Puglia, Italy). Patients were randomly assigned to TF-CBT (n = 14) or EMDR (n = 17) psychotherapy. Clinical assessment was performed using the Clinician-Administered PTSD Scale (CAPS), the Davidson Trauma Scale (DTS) and the Work and Social Adjustment Scale (WSAS), both at baseline and after treatment. All patients underwent a fMRI data acquisition session before and after treatment, aimed at characterizing their functional connectivity (FC) profile at rest, as well as potential connectivity changes associated with the clinical impact of psychotherapy. Both EMDR and TF-CBT induced statistically significant changes in clinical scores, with no difference in the clinical impact of the two treatments. Specific changes in FC correlated with the improvement at the different clinical scores, and differently for EMDR and TF-CBT. However, a similarity in the connectivity changes associated with changes in CAPS in both groups was also observed. Specifically, changes at CAPS in the entire sample correlated with an (i) increase in connectivity between the bilateral superior medial frontal gyrus and right temporal pole, and a (ii) decrease in connectivity between left cuneus and left temporal pole. Results point to a similar, beneficial psychological impact of EMDR and TF-CBT for treatment of natural-disaster PTSD patients. Neuroimaging data suggest a similar neurophysiological substrate for clinical improvement following EMDR and TF-CBT, involving changes affecting bilateral temporal pole connectivity.

Project description:BackgroundThe limited available data suggest that the prevalence of problem gambling is increased among young adults with first-episode psychosis, possibly due in part to several risk factors for problem gambling that are common in this population. Aripiprazole, a widely used antipsychotic drug, has also been linked to cases of problem gambling, but causality remains uncertain. Although the consequences of problem gambling further hinder the recovery of people with first-episode psychosis, there is a paucity of research about this comorbidity and its risk factors. Additionally, to our knowledge, no screening instrument for problem gambling tailored to these individuals exists, contributing to its under-recognition. Further, treatment approaches for problem gambling adapted to this population are at an embryonic stage, while existing treatments effectiveness remains to be documented. Using an innovative screening and assessment procedure for problem gambling, this study aims to identify risk factors for problem gambling among people with first-episode psychosis and to document the effectiveness of standard treatment approaches.MethodsThis is a multicenter prospective cohort study conducted in two first-episode psychosis clinics, including all patients admitted between November 1st, 2019, and November 1st, 2023, followed for up to 3 years until May 1st, 2024. These 2 clinics admit approximately 200 patients annually, for an expected sample size of 800 individuals. The primary outcome is the occurrence of a DSM-5 diagnosis of gambling disorder. All patients are screened and evaluated for problem gambling using a systematic procedure at admission, and every 6 months thereafter. Socio-demographic and clinical variables are prospectively extracted from the patients' medical records. The nature and effectiveness of treatments for problem gambling offered to affected individuals are also documented from medical records. Survival analyses with Cox regression models will be used to identify potential risk factors for problem gambling. Descriptive statistics will document the effectiveness of treatments for problem gambling in this population.DiscussionA better understanding of potential risk factors for problem gambling among people with first-episode psychosis will allow for better prevention and detection of this neglected comorbidity. Results of this study will also hopefully raise clinicians' and researchers' awareness and serve as the basis to adapted treatments that will better support recovery.Trial registrationClinicalTrials.gov, NCT05686772. Retrospectively registered, 9 January 2023.

Project description:INTRODUCTION:Survival after trauma has considerably improved. This warrants research on non-fatal outcome. We aimed to identify characteristics associated with both short and long-term health status (HS) after trauma and to describe the recovery patterns of HS and psychological outcomes during 24 months of follow-up. METHODS:Hospitalized patients with all types of injuries were included. Data were collected at 1 week 1, 3, 6, 12, and 24 months post-trauma. HS was assessed with the EuroQol-5D-3L (EQ-5D-3L) and the Health Utilities Index Mark 2 and 3 (HUI2/3). For the screening of symptoms of post-traumatic stress, anxiety and depression, the Impact of Event Scale (IES) and the Hospital Anxiety and Depression Scale (HADS) subscale anxiety (HADSA) and subscale depression (HADSD) were used. Recovery patterns of HS and psychological outcomes were examined with linear mixed model analyses. RESULTS:A total of 4,883 patients participated (median age 68 (Interquartile range 53-80); 50% response rate). The mean (Standard Deviation (SD)) pre-injury EQ-5D-3L score was 0.85 (0.23). One week post-trauma, mean (SD) EQ-5D-3L, HUI2 and HUI3 scores were 0.49 (0.32), 0.61 (0.22) and 0.38 (0.31), respectively. These scores significantly improved to 0.77 (0.26), 0.77 (0.21) and 0.62 (0.35), respectively, at 24 months. Most recovery occurred up until 3 months. At long-term follow-up, patients of higher age, with comorbidities, longer hospital stay, lower extremity fracture and spine injury showed lower HS. The mean (SD) scores of the IES, HADSA and HADSD were respectively 14.80 (15.80), 4.92 (3.98) and 5.00 (4.28), respectively, at 1 week post-trauma and slightly improved over 24 months post-trauma to 10.35 (14.72), 4.31 (3.76) and 3.62 (3.87), respectively. DISCUSSION:HS and psychological symptoms improved over time and most improvements occurred within 3 months post-trauma. The effects of severity and type of injury faded out over time. Patients frequently reported symptoms of post-traumatic stress. TRIAL REGISTRATION:ClinicalTrials.gov identifier: NCT02508675.

Project description:Despite advances in genetic research, causal variants affecting risk for schizophrenia remain poorly characterized, and the top 108 loci identified through genome-wide association studies (GWAS) explain only 3.4% of variance in risk profiles. Such work is defining the highly complex nature of this condition, with omnigenic models of schizophrenia suggesting that gene regulatory networks are sufficiently interconnected such that altered expression of any "peripheral" gene in a relevant cell type has the capacity to indirectly modulate the expression of "core" schizophrenia-associated genes. This wealth of associated genes with small effect sizes makes identifying new druggable targets difficult, and current pharmacological treatments for schizophrenia can involve serious side effects. However, the fact that the majority of schizophrenia genome-wide associated variants fall within non-coding DNA is suggestive of their potential to modulate gene regulation. This would be consistent with risks that can be mediated in a "gene × environment" (G × E) manner. Stress and trauma can alter the regulation of key brain-related pathways over the lifetime of an individual, including modulation of brain development, and neurochemistry in the adult. Recent studies demonstrate a significant overlap between psychotic symptoms and trauma, ranging from prior trauma contributing to psychosis, as well as trauma in response to the experience of psychosis itself or in response to treatment. Given the known effects of trauma on both CNS gene expression and severity of psychosis symptoms, it may be that pharmacological treatment alone risks leaving individuals with a highly stressful and unresolved environmental component that continues to act in a "G × E" manner, with the likelihood that this would negatively impact recovery and relapse risk. This review aims to cover the recent advances elucidating the complex genetic architecture of schizophrenia, as well as the long-term effects of early life trauma on brain function and future mental health risk. Further, the evidence demonstrating the role of ongoing responses to trauma or heightened stress sensitivity, and their impact on the course of illness and recovery, is presented. Finally, the need for trauma-informed approaches and psychological therapy-based interventions is discussed, and a brief overview of the evidence to determine their utility is presented.

Project description: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. 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.

Dataset Information

A Multicenter Phase II RCT to Compare the Effectiveness of EMDR Versus TAU in Patients With a First-Episode Psychosis and Psychological Trauma: A Protocol Design.

Publications

A Multicenter Phase II RCT to Compare the Effectiveness of EMDR Versus TAU in Patients With a First-Episode Psychosis and Psychological Trauma: A Protocol Design.

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