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EMDR in Psychiatric Inpatients With Severe Mental Disorder

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ClinicalTrials.gov Identifier: NCT03664713
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : March 20, 2019
Sponsor:
Collaborators:
EMDR Europe
Fundacion IMIM
Information provided by (Responsible Party):
Parc de Salut Mar

Brief Summary:
The study of psychological trauma has become increasingly important in the field of mental health research due to the strong negative impact it has on the course and prognosis of psychiatric pathologies. However, from a clinical point of view it is still an overlooked and even ignored component. There is scientific evidence that treating traumatic events at outpatient hospital services in patients with severe mental disorder improves both trauma-related symptoms and clinical symptoms. A first-line treatment for psychological trauma is Eye Movement Desensitization and Reprocessing (EMDR) therapy. This therapy is recommended by the World Health Organization for treating Post-Traumatic Stress Disorder and which has obtained promising first results in patients with severe mental disorder. This project proposes to test whether EMDR therapy in addition to standard treatment is more effective than standard treatment alone in psychiatric in-patients with severe mental disorder, in terms of reducing symptoms related to psychopathology and trauma, and in terms of improving functioning. Our first hypothesis is that EMDR will be more effective than standard treatment alone in reducing the severity of psychiatric symptoms. Our second hypothesis is that EMDR will be more effective than standard treatment alone in reducing the severity of trauma-related symptoms. Our third hypothesis is that EMDR will be more effective than standard treatment alone in improving functioning.

Condition or disease Intervention/treatment Phase
Severe Mental Disorder Psychological Trauma Behavioral: Eye Movement Desensitization and Reprocessing (EMDR) Therapy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The project will be carried out in the sub-acute and long-stay inpatient wards of Parc de Salut Mar, Institute of Neuropsychiatry and Addiction (INAD), located in the Centre Forum. It consists of a single-blind RCT with two parallel branches, 1) individual therapy with EMDR and TAU, and 2) TAU only, with patients matched by age, sex, psychiatric diagnosis and premorbid IQ. Once the patient has been stabilized with psychotropic medication and has begun taking part in the psychosocial activities proposed by the unit, they will be offered the chance to receive 25 individual EMDR therapy sessions, each lasting 60 minutes. The patients will be evaluated at the beginning of their hospital stay, again when discharged from the unit and then at 6 and 12 month follow up.
Masking: Single (Outcomes Assessor)
Masking Description: Evaluators will be blind to treatment. Participants cannot be blind to treatment due to the impossibility of creating a sham alternative to EMDR therapy, due to its use of bilateral stimulation.
Primary Purpose: Treatment
Official Title: Efficacy of Eye Movement Desensitization and Reprocessing (EMDR) Therapy Compared to Treatment As Usual (TAU) in Psychiatric Inpatients With Severe Mental Disorder and a History of Psychological Trauma
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EMDR plus TAU
Individual Eye Movement Desensitization and Reprocessing (EMDR) Therapy: This consists of 25 individual sessions of 60 minutes each, applying the standard protocol with the existing validated modifications for specific pathologies. The standard EMDR protocol consists of 8 phases: 1) Patient history; 2) Patient preparation; 3) Evaluation of the main aspects of the traumatic memory; 4) Desensitization of the memory; 5) Installation of the positive cognition; 6) Body scan; 7) Close and 8) Reevaluation.
Behavioral: Eye Movement Desensitization and Reprocessing (EMDR) Therapy
EMDR is an 8-phase psychological treatment composed of protocols and standardized procedures applicable to both adults and children. The eight phases (patient history, patient preparation, evaluation of the main aspects of the memory, desensitization of the traumatic memory, installation of the positive cognition, body scan, close and re-evaluation) and the protocol of the time line of past-present-future, allow a holistic evaluation of the image of the traumatic memory, and allow for the patient to be well-prepared before processing past events which underlie current pathology, current situations which cause perturbation, and challenges and possible future stimuli which might lead to the appearance of symptoms. (Shapiro, 2014)

No Intervention: TAU only
Treatment As Usual (TAU): The patients in this condition will participate in the psychosocial activities proposed by the inpatient unit (with a focus on autonomy, psychoeducation, treatment adherence, insight, functioning and family interventions). Patients who receive EMDR therapy will also participate in these activities.



Primary Outcome Measures :
  1. Change in clinical severity from baseline to post-treatment at 6 months and follow up at 12 months. [ Time Frame: The stated improvement will be seen at 6 months and maintained at 12 months. ]
    There will be a reduction in clinical severity of symptoms in the EMDR group as compared to the control group in terms of total score on the Brief Psychiatric Rating Scale (BPRS).


Secondary Outcome Measures :
  1. Change in global clinical severity from baseline to post-treatment at 6 months and follow up at 12 months. [ Time Frame: The stated improvement will be seen at 6 months and maintained at 12 months. ]
    There will be a reduction in global clinical severity in the EMDR group as compared to the control group as measured by the Clinical Global Impression Scale (CGI).

  2. Change in depression symptoms from baseline to post-treatment at 6 months and follow up at 12 months. [ Time Frame: The stated improvement will be seen at 6 months and maintained at 12 months. ]
    There will be a reduction in depression symptoms in the EMDR group as compared to the control group as measured by the Hamilton Depression Rating Scale (HDRS).

  3. Change in mania symptoms from baseline to post-treatment at 6 months and follow up at 12 months. [ Time Frame: The stated improvement will be seen at 6 months and maintained at 12 months. ]
    There will be a reduction in symptoms of mania in the EMDR group as compared to the control group as measured by the Young Mania Rating Scale (YMRS).

  4. Change in symptoms of schizophrenia from baseline to post-treatment at 6 months and follow up at 12 months. [ Time Frame: The stated improvement will be seen at 6 months and maintained at 12 months. ]
    There will be a reduction in symptoms related to schizophrenia in the EMDR group as compared to the control group as measured by the Positive and Negative Symptoms Scale (PANSS).

  5. Change in number of patients with a Post-traumatic Stress Disorder (PTSD) diagnosis from baseline to post-treatment at 6 months and follow up at 12 months. [ Time Frame: The stated improvement will be seen at 6 months and maintained at 12 months. ]
    Patients in the EMDR group will show a reduction in proportion of PTSD diagnosis as compared to the control group, as measured by the Global Evaluation of Posttraumatic Stress (EGEP-5).

  6. Change in current impact of a traumatic event from baseline to post-treatment at 6 months and follow up at 12 months.. [ Time Frame: The stated improvement will be seen at 6 months and maintained at 12 months. ]
    Patients in the EMDR group will show a reduced impact of a traumatic event as compared to the control group, as measured by the Impact of Events Scale-Revised (IES-R).

  7. Change in number of dissociative symptoms from baseline to post-treatment at 6 months and follow up at 12 months. [ Time Frame: The stated improvement will be seen at 6 months and maintained at 12 months. ]
    Patients in the EMDR group will show a reduced number of dissociative symptoms as compared to the control group, as measured by the Dissociative Experiences Scale (DES).

  8. Change in global functioning from baseline to post-treatment at 6 months and follow up at 12 months. [ Time Frame: The stated improvement will be seen at 6 months and maintained at 12 months. ]
    Patients in the EMDR group will show an improvement in their functional capacity as compared to the control group through the following scale: Functional Assessment Screening Tool (FAST), measuring the following areas: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships and leisure time.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • sub-acute or long-stay ward in-patients diagnosed with an affective or non-affective psychotic disorder, as per DSM-V criteria, who also present a history of traumatic events.

Exclusion Criteria:

  • abuse or dependence on substances in the previous 3 months (except nicotine), organic brain disease, presence of structured suicidal ideation and having received a trauma-focused therapy in the last 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): NCT03664713


Contacts
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Contact: Ana Moreno-Alcázar, PhD (0034) 93 326 85 00 ext 8403 amoreno1@imim.es
Contact: Bridget M Hogg, MSc (0034) 93 326 85 00 ext 8403 bhogg@imim.es

Locations
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Spain
Ana Moreno-Alcázar Recruiting
Barcelona, Spain, 08019
Contact: Ana Moreno-Alcázar, PhD    003 4933 26 85 00 ext 8403    amoreno1@imim.es   
Sponsors and Collaborators
Parc de Salut Mar
EMDR Europe
Fundacion IMIM
Investigators
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Principal Investigator: Ana Moreno-Alcázar, PhD Parc de Salut Mar; Fundación IMIM; CIBERSAM.

Publications:

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Responsible Party: Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT03664713     History of Changes
Other Study ID Numbers: 2017/7457/I
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Currently there are no plans.

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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:
Severe Mental Disorder
Psychological Trauma
Eye Movement Desensitization and Reprocessing Therapy

Additional relevant MeSH terms:
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Disease
Mental Disorders
Psychotic Disorders
Psychological Trauma
Wounds and Injuries
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders