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A Rater-blinded RCT to Compare Effectiveness of EMDR vs TAU in Patients With First Episode Psychosis and History of Psychological Trauma

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ClinicalTrials.gov Identifier: NCT03991377
Recruitment Status : Recruiting
First Posted : June 19, 2019
Last Update Posted : March 16, 2021
Sponsor:
Collaborators:
Consorci Hospitalari de Vic
Hospital Mutua de Terrassa
Althaia Xarxa Assistencial Universitària de Manresa
Information provided by (Responsible Party):
Parc de Salut Mar

Brief Summary:
The main objective of this project is to analyze whether EMDR therapy, as an adjuvant to usual treatment, is effective in reducing post-traumatic stress and psychotic/affective symptoms in patients with a FEP and comorbid psychological trauma associated with first hospital admission and / or previous stressful life event.

Condition or disease Intervention/treatment Phase
Psychotic Episode Psychological Trauma Behavioral: Eye movement desensitization and reprocessing therapy Drug: Treatment as usual Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a multicenter phase II rater-blinded randomized controlled trial with two parallel branches, EMDR + TAU and TAU, of 80 FEP patients who have a history of psychological trauma, even if they do not currently meet DSM-V criteria for PTSD.
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: A Multicenter Phase II Rater-blinded Randomized Controlled Trial (RCT) to Compare Effectiveness of Eye Movement Desensitization Reprocessing Therapy (EMDR) vs Treatment as Usual (TAU) in First Episode Psychosis and History of Trauma.
Actual Study Start Date : April 25, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EMDR therapy
Patients in the psychotherapy intervention will receive up to 20 individual sessions of EMDR, weekly sessions, of 60 minutes each, using the standard EMDR therapy protocol developed by Shapiro to treat both current and past trauma-related symptom.
Behavioral: Eye movement desensitization and reprocessing therapy

EMDR is an integrative psychotherapy that uses standardized protocols and elements of cognitive-behavioral, interpersonal, and body-centered therapies, as well as dual stimulation (e.g., side-to-side eye movements).

The current standard protocol includes eight phases:

  1. Patient history.
  2. Patient preparation.
  3. Patient assessment.
  4. Memory desensitization.
  5. Installing the positive cognition.
  6. Body scan.
  7. Closure.
  8. Reevaluation.
Other Name: EMDR

Drug: Treatment as usual
Once patients are discharged from hospital, they will be treated by the multidisciplinary team of the Specialized Early Intervention Programme for Incipient Psychosis (PAE-TPI) as part of their usual treatment, which consists of a multidisciplinary approach that includes pharmacological treatment and psychological support, from social workers or nursing 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.
Other Name: TAU

Active Comparator: Treatment as usual
Multidisciplinary approach that includes pharmacological treatment and psychological support.
Drug: Treatment as usual
Once patients are discharged from hospital, they will be treated by the multidisciplinary team of the Specialized Early Intervention Programme for Incipient Psychosis (PAE-TPI) as part of their usual treatment, which consists of a multidisciplinary approach that includes pharmacological treatment and psychological support, from social workers or nursing 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.
Other Name: TAU




Primary Outcome Measures :
  1. Reduction of the severity of trauma-related symptoms [ Time Frame: Change from baseline to visits at 6 and 12 months ]
    To measure severity and changes in trauma-related symptoms with the Impact of Event Scale - Revised. Items are rated on a 5-point Likert scale ranging from 0 and 4, yielding a total score ranging from 0 to 88.


Secondary Outcome Measures :
  1. Making a PTSD diagnosis [ Time Frame: Change from baseline to visits at 6 and 12 months ]
    To diagnose PTSD with the Global Assessment of Posttraumatic Stress Questionnaire. Higher scores indicate more severity in trauma-related symptoms.

  2. Detection of dissociative symptoms [ Time Frame: Change from baseline to visits at 6 and 12 months ]
    To assess dissociative symptoms with the Dissociative Experiences Scale. An overall mean score ranging from 0 to 100. The higher score, the higher the severity of the dissociative symptoms.

  3. Detection of Childhood life traumatic events [ Time Frame: Childhood period. It is administered only during the baseline visit. ]
    To assess life events with the Childhood Trauma Questionnaire. A 5-point Likert scale is used, ranging from "Never True" to "Very Often True".

  4. Detection of traumatic events in the last year [ Time Frame: The last year. It is administered only during the baseline visit. ]
    To assess events with The Holmes-Rahe Life Stress Inventory. 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.

  5. Reduction of positive psychotic symptoms [ Time Frame: Change from baseline to visits at 6 and 12 months ]
    To measure changes in the Positive and Negative Syndrome Scale (PANSS) . It ranges from 7 to 49: the higher the score, the worse the positive psychotic symptoms.

  6. Reduction in depressive symptoms [ Time Frame: Change from baseline to visits at 6 and 12 months ]
    To measure changes in the Beck Depression II Questionnaire. Total scores range from 0 to 52: the higher the score, the worse the depressive symptoms.

  7. Reduction of (hypo) manic symptoms [ Time Frame: Change from baseline to visits at 6 and 12 months ]
    To measure changes in the Young Mania Rating Scale. It ranges from 0 to 130: the higher the score, the worse the manic symptoms.

  8. Improvement of global functioning [ Time Frame: Change from baseline to visits at 6 and 12 months ]
    To measure changes with the Global Assessment of Functioning Scale. The global score ranges from 0 to 100. The higher the score, the higher the functional status.

  9. Improving of the quality of life associated with health [ Time Frame: Change from baseline to visits at 6 and 12 months ]
    To measure changes with the Standardized Instrument for Evaluating Quality of Life Associated with Health.The global score ranging from 0 to 100. The lower scores indicate poorer awareness of the quality of life associated with health.

  10. Improving awareness of having a mental disorder and of their need for treatment [ Time Frame: Change from baseline to visits at 6 and 12 months ]
    To measure changes in the with the Beck Cognitive Insight Scale. The total score ranging from 0 to 45. The higher score on the scale, the lower severity of negative symptomatology.

  11. Improving adherence to pharmacological treatment [ Time Frame: Change from baseline to visits at 6 and 12 months ]
    To measure changes in the attitude towards medication with the Drug Attitude Inventory. The total score can oscillate between 10 and 20. The higher the score, the more positive the perceived effect of the medication.

  12. Reducing in the number of relapses [ Time Frame: Change from baseline to visits at 6 and 12 months ]
    To measure relapses with the register of the number hospital admissions and/or emergency visits



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age ≥16 years old
  • presence of one or more traumatic events, causing symptoms associated with the trauma (Impact of Event Scale-Revised >0 and Subjective Units of Distress >5), but it is not necessary that traumatic events meet DSM-5 criteria for PTSD
  • psychotic symptoms/psychiatric hospitalization will be considered a traumatic event when the criteria for a trauma-related disorder or stress factors according to DSM-V (Post-Traumatic Stress Disorder, Acute Stress Disorder, and Other Trauma-related Disorder and unspecified stress factors) are also met
  • ability to read and write in Spanish.

Exclusion Criteria:

  • suicidal risk, to be operated on the basis of: suicide risk scale - suicidal risk module scale MINI≥ 1 or suicide attempt in the last six months
  • presence of organic brain diseases
  • have received trauma-focused therapy in the past 2 years.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03991377


Contacts
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Contact: BENEDIKT L AMANN, PhD 34933268500 ext 8403 BAMANN@PARCDESALUTMAR.CAT
Contact: ALICIA VALIENTE-GÓMEZ, PhD 34933268500 ext 8403 AVALIENTE@PARCDESALUTMAR.CAT

Locations
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Spain
Parc de Salut Mar Recruiting
Barcelona, Spain, 08003
Sponsors and Collaborators
Parc de Salut Mar
Consorci Hospitalari de Vic
Hospital Mutua de Terrassa
Althaia Xarxa Assistencial Universitària de Manresa
Investigators
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Principal Investigator: BENEDIKT L AMANN, PhD Parc de Salut Mar
Publications:
Báguena, M., Villarroya, E., Beleña, Á., Díaz, A., Roldán, C., and Reig, R. (2001). Propiedades Psycometricas de la Version Española de la Escala Revisionada de Impacto del Estresor (EIE-R). Anal. y Modif. Conduct. 27, 581-604.
Bobes., J. (1998). A Spanish validation study of the MINI International Neuropsychiatric Interview. SEC55.Diagnostic tools Prim. care psychiatry, 198s-199s.
González de Rivera, J. L., and Morera Fumero, A. (1983). La valoración de sucesos vitales : Adaptación española de la escala de Holmes y Rahe. Psiquis (Mexico). 4, 7-11.
http://www.who.int/mediacentre/news/releases/2013/trauma_mental_health_20130806/es/ (2013).
https://euroqol.org/eq-5d-instruments/eq-5d-5l-about/ (2019).
Icaran, E., Colom, R., and Orengo Garcia, F. (1996). Dissociative experiences: A measurement scale. Exp. disociativas una escala medida. 70, 69-84.
María Crespo y Ma Mar Gómez (2012). Posttraumatic Stress Assessment: Introducing the Global Assessment of Posttraumatic Stress Questionnaire. Clínica y Salud 23, 25-41.
Shapiro, F. (2001). Eye movement desensitization and reprocessing: Basic principles, protocols, and procedures (2nd ed.). Available at: http://proxy.library.nd.edu/login?url=http://search.proquest.com/docview/619595584?accountid=12874 LA - English.
Vázquez, C., and Sanz, J. (1999). Fiabilidad y validez de la versión española del Inventario para la Depresión de Beck de 1978 en pacientes con trastornos psicológicos. Clínica y Salud 10, 59-81.
Weiss, D. S., and Marmar, C. R. (1997a). The Impact of Event Scale-Revised. doi:10.1007/978-0-387-70990-1_10.
Weiss, D. S., and Marmar, C. R. (1997b). "The Impact of Event Scale-Revised.," in Assessing psychological trauma and PTSD, 399-411.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT03991377    
Other Study ID Numbers: PI18/00009
First Posted: June 19, 2019    Key Record Dates
Last Update Posted: March 16, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Parc de Salut Mar:
First psychotic episode, psychological trauma, EMDR therapy, Treatment as usual
Additional relevant MeSH terms:
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Wounds and Injuries
Psychotic Disorders
Mental Disorders
Psychological Trauma
Schizophrenia Spectrum and Other Psychotic Disorders
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders