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
BackgroundPatients 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 (...
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Frontiers Media S.A.
2020-02-01
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| Series: | Frontiers in Psychiatry |
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| Online Access: | https://www.frontiersin.org/article/10.3389/fpsyt.2019.01023/full |
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| author | Alicia Valiente-Gómez Alicia Valiente-Gómez Alicia Valiente-Gómez Alicia Valiente-Gómez Nuria Pujol Nuria Pujol Nuria Pujol Ana Moreno-Alcázar Ana Moreno-Alcázar Ana Moreno-Alcázar Ana Moreno-Alcázar Joaquim Radua Joaquim Radua Joaquim Radua Eila Monteagudo-Gimeno Eila Monteagudo-Gimeno Itxaso Gardoki-Souto Itxaso Gardoki-Souto Itxaso Gardoki-Souto Bridget Hogg Bridget Hogg Bridget Hogg Maria José Álvarez Gemma Safont Gemma Safont Gemma Safont Walter Lupo Victor Pérez Victor Pérez Victor Pérez Victor Pérez Benedikt L. Amann Benedikt L. Amann Benedikt L. Amann Benedikt L. Amann the FEP-EMDR Research Group Rebeca Alayón Montserrat Coll Jairo Santiago García Eslava Ezequiel Pérez Sánchez Carla Llimona Cristina Macias Anna Mané Lorena Marín Clara Montserrat Miriam Morales Ana María Rodríguez Roberto Sánchez Amira Trabsa Daniel Bergé |
| author_facet | Alicia Valiente-Gómez Alicia Valiente-Gómez Alicia Valiente-Gómez Alicia Valiente-Gómez Nuria Pujol Nuria Pujol Nuria Pujol Ana Moreno-Alcázar Ana Moreno-Alcázar Ana Moreno-Alcázar Ana Moreno-Alcázar Joaquim Radua Joaquim Radua Joaquim Radua Eila Monteagudo-Gimeno Eila Monteagudo-Gimeno Itxaso Gardoki-Souto Itxaso Gardoki-Souto Itxaso Gardoki-Souto Bridget Hogg Bridget Hogg Bridget Hogg Maria José Álvarez Gemma Safont Gemma Safont Gemma Safont Walter Lupo Victor Pérez Victor Pérez Victor Pérez Victor Pérez Benedikt L. Amann Benedikt L. Amann Benedikt L. Amann Benedikt L. Amann the FEP-EMDR Research Group Rebeca Alayón Montserrat Coll Jairo Santiago García Eslava Ezequiel Pérez Sánchez Carla Llimona Cristina Macias Anna Mané Lorena Marín Clara Montserrat Miriam Morales Ana María Rodríguez Roberto Sánchez Amira Trabsa Daniel Bergé |
| author_sort | Alicia Valiente-Gómez |
| collection | DOAJ |
| description | BackgroundPatients 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.ObjectivesTo 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.MethodsThis 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.ConclusionThis 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 Registrationwww.ClinicalTrials.gov, identifier: NCT03991377 |
| first_indexed | 2024-04-12T08:41:18Z |
| format | Article |
| id | doaj.art-008a858e9c62419fa99ceaff2440527b |
| institution | Directory Open Access Journal |
| issn | 1664-0640 |
| language | English |
| last_indexed | 2024-04-12T08:41:18Z |
| publishDate | 2020-02-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Psychiatry |
| spelling | doaj.art-008a858e9c62419fa99ceaff2440527b2022-12-22T03:39:51ZengFrontiers Media S.A.Frontiers in Psychiatry1664-06402020-02-011010.3389/fpsyt.2019.01023505639A Multicenter Phase II RCT to Compare the Effectiveness of EMDR Versus TAU in Patients With a First-Episode Psychosis and Psychological Trauma: A Protocol DesignAlicia Valiente-Gómez0Alicia Valiente-Gómez1Alicia Valiente-Gómez2Alicia Valiente-Gómez3Nuria Pujol4Nuria Pujol5Nuria Pujol6Ana Moreno-Alcázar7Ana Moreno-Alcázar8Ana Moreno-Alcázar9Ana Moreno-Alcázar10Joaquim Radua11Joaquim Radua12Joaquim Radua13Eila Monteagudo-Gimeno14Eila Monteagudo-Gimeno15Itxaso Gardoki-Souto16Itxaso Gardoki-Souto17Itxaso Gardoki-Souto18Bridget Hogg19Bridget Hogg20Bridget Hogg21Maria José Álvarez22Gemma Safont23Gemma Safont24Gemma Safont25Walter Lupo26Victor Pérez27Victor Pérez28Victor Pérez29Victor Pérez30Benedikt L. Amann31Benedikt L. Amann32Benedikt L. Amann33Benedikt L. Amann34the FEP-EMDR Research GroupRebeca AlayónMontserrat CollJairo Santiago García EslavaEzequiel Pérez SánchezCarla LlimonaCristina MaciasAnna ManéLorena MarínClara MontserratMiriam MoralesAna María RodríguezRoberto SánchezAmira TrabsaDaniel BergéCentre Forum Research Unit, Institut de Neuropsiquiatria i Addiccions (INAD), Parc de Salut Mar, Barcelona, SpainIMIM (Hospital del Mar Medical Research Institute), Barcelona, SpainCIBERSAM, Madrid, SpainDepartment of Psychiatry and Forensic Medicine, School of Medicine Universitat Autònoma de Barcelona, Barcelona, SpainIMIM (Hospital del Mar Medical Research Institute), Barcelona, SpainCIBERSAM, Madrid, SpainInstitut de Neuropsiquiatria i Addiccions (INAD), Hospital del Mar, Barcelona, SpainCentre Forum Research Unit, Institut de Neuropsiquiatria i Addiccions (INAD), Parc de Salut Mar, Barcelona, SpainIMIM (Hospital del Mar Medical Research Institute), Barcelona, SpainCIBERSAM, Madrid, SpainDepartment of Psychiatry and Forensic Medicine, School of Medicine Universitat Autònoma de Barcelona, Barcelona, SpainInstitut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, SpainDepartment of Psychosis Studies, Institute of Psychiatry, Psychology & Neuroscience, King’s College London, London, United KingdomDepartment of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet, Stockholm, SwedenDepartment of Psychiatry and Forensic Medicine, School of Medicine Universitat Autònoma de Barcelona, Barcelona, SpainInstitut de Neuropsiquiatria i Addiccions (INAD), Hospital del Mar, Barcelona, SpainCentre Forum Research Unit, Institut de Neuropsiquiatria i Addiccions (INAD), Parc de Salut Mar, Barcelona, SpainIMIM (Hospital del Mar Medical Research Institute), Barcelona, SpainDepartment of Psychiatry and Forensic Medicine, School of Medicine Universitat Autònoma de Barcelona, Barcelona, SpainCentre Forum Research Unit, Institut de Neuropsiquiatria i Addiccions (INAD), Parc de Salut Mar, Barcelona, SpainIMIM (Hospital del Mar Medical Research Institute), Barcelona, SpainDepartment of Psychiatry and Forensic Medicine, School of Medicine Universitat Autònoma de Barcelona, Barcelona, SpainMental Health Department, Vic Hospital Consortium, Barcelona, SpainCIBERSAM, Madrid, SpainDepartment of Psychiatry and Forensic Medicine, School of Medicine Universitat Autònoma de Barcelona, Barcelona, Spain0University Hospital Mutua Terrassa, Barcelona, SpainCentre Forum Research Unit, Institut de Neuropsiquiatria i Addiccions (INAD), Parc de Salut Mar, Barcelona, SpainIMIM (Hospital del Mar Medical Research Institute), Barcelona, SpainCIBERSAM, Madrid, SpainDepartment of Psychiatry and Forensic Medicine, School of Medicine Universitat Autònoma de Barcelona, Barcelona, SpainInstitut de Neuropsiquiatria i Addiccions (INAD), Hospital del Mar, Barcelona, SpainCentre Forum Research Unit, Institut de Neuropsiquiatria i Addiccions (INAD), Parc de Salut Mar, Barcelona, SpainIMIM (Hospital del Mar Medical Research Institute), Barcelona, SpainCIBERSAM, Madrid, SpainDepartment of Psychiatry and Forensic Medicine, School of Medicine Universitat Autònoma de Barcelona, Barcelona, SpainBackgroundPatients 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.ObjectivesTo 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.MethodsThis 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.ConclusionThis 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 Registrationwww.ClinicalTrials.gov, identifier: NCT03991377https://www.frontiersin.org/article/10.3389/fpsyt.2019.01023/fullfirst episode psychosispsychological traumapost-psychotic posttraumatic stresscomorbidityEMDR therapytreatment as usual |
| spellingShingle | Alicia Valiente-Gómez Alicia Valiente-Gómez Alicia Valiente-Gómez Alicia Valiente-Gómez Nuria Pujol Nuria Pujol Nuria Pujol Ana Moreno-Alcázar Ana Moreno-Alcázar Ana Moreno-Alcázar Ana Moreno-Alcázar Joaquim Radua Joaquim Radua Joaquim Radua Eila Monteagudo-Gimeno Eila Monteagudo-Gimeno Itxaso Gardoki-Souto Itxaso Gardoki-Souto Itxaso Gardoki-Souto Bridget Hogg Bridget Hogg Bridget Hogg Maria José Álvarez Gemma Safont Gemma Safont Gemma Safont Walter Lupo Victor Pérez Victor Pérez Victor Pérez Victor Pérez Benedikt L. Amann Benedikt L. Amann Benedikt L. Amann Benedikt L. Amann the FEP-EMDR Research Group Rebeca Alayón Montserrat Coll Jairo Santiago García Eslava Ezequiel Pérez Sánchez Carla Llimona Cristina Macias Anna Mané Lorena Marín Clara Montserrat Miriam Morales Ana María Rodríguez Roberto Sánchez Amira Trabsa Daniel Bergé 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 Frontiers in Psychiatry first episode psychosis psychological trauma post-psychotic posttraumatic stress comorbidity EMDR therapy treatment as usual |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | first episode psychosis psychological trauma post-psychotic posttraumatic stress comorbidity EMDR therapy treatment as usual |
| url | https://www.frontiersin.org/article/10.3389/fpsyt.2019.01023/full |
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multicenterphaseiircttocomparetheeffectivenessofemdrversustauinpatientswithafirstepisodepsychosisandpsychologicaltraumaaprotocoldesign AT thefepemdrresearchgroup multicenterphaseiircttocomparetheeffectivenessofemdrversustauinpatientswithafirstepisodepsychosisandpsychologicaltraumaaprotocoldesign AT rebecaalayon multicenterphaseiircttocomparetheeffectivenessofemdrversustauinpatientswithafirstepisodepsychosisandpsychologicaltraumaaprotocoldesign AT montserratcoll multicenterphaseiircttocomparetheeffectivenessofemdrversustauinpatientswithafirstepisodepsychosisandpsychologicaltraumaaprotocoldesign AT jairosantiagogarciaeslava multicenterphaseiircttocomparetheeffectivenessofemdrversustauinpatientswithafirstepisodepsychosisandpsychologicaltraumaaprotocoldesign AT ezequielperezsanchez multicenterphaseiircttocomparetheeffectivenessofemdrversustauinpatientswithafirstepisodepsychosisandpsychologicaltraumaaprotocoldesign AT carlallimona 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