EMDR in Psychiatric Inpatients With Severe Mental Disorder

NCT03664713 | Completed

• 1 other identifier: 2017/7457/I
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Mental Disorder; Psychological Trauma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in clinical severity from baseline to post-treatment at 6 months and follow up 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).

  The stated improvement will be seen at 6 months and maintained at 12 months.

Secondary Outcomes (8)

• Change in global clinical severity from baseline to post-treatment at 6 months and follow up at 12 months.

  The stated improvement will be seen at 6 months and maintained at 12 months.

• Change in depression symptoms from baseline to post-treatment at 6 months and follow up at 12 months.

  The stated improvement will be seen at 6 months and maintained at 12 months.

• Change in mania symptoms from baseline to post-treatment at 6 months and follow up at 12 months.

  The stated improvement will be seen at 6 months and maintained at 12 months.

• Change in symptoms of schizophrenia from baseline to post-treatment at 6 months and follow up at 12 months.

  The stated improvement will be seen at 6 months and maintained at 12 months.

• 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.

  The stated improvement will be seen at 6 months and maintained at 12 months.

Study Arms (2)

EMDR plus TAU

EXPERIMENTAL

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

TAU only

NO INTERVENTION

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.

Interventions

Eye Movement Desensitization and Reprocessing (EMDR) Therapy BEHAVIORAL

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)

EMDR plus TAU

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Parc de Salut Mar: lead
• EMDR Europe: collaborator
• Fundacion IMIM: collaborator

Study Sites (1)

Ana Moreno-Alcázar

Barcelona, 08019, Spain

Location

Related Publications (12)

• Shapiro F. The role of eye movement desensitization and reprocessing (EMDR) therapy in medicine: addressing the psychological and physical symptoms stemming from adverse life experiences. Perm J. 2014 Winter;18(1):71-7. doi: 10.7812/TPP/13-098.

  PMID: 24626074 BACKGROUND

• Bortolato B, Kohler CA, Evangelou E, Leon-Caballero J, Solmi M, Stubbs B, Belbasis L, Pacchiarotti I, Kessing LV, Berk M, Vieta E, Carvalho AF. Systematic assessment of environmental risk factors for bipolar disorder: an umbrella review of systematic reviews and meta-analyses. Bipolar Disord. 2017 Mar;19(2):84-96. doi: 10.1111/bdi.12490. Epub 2017 May 3.

  PMID: 28470927 BACKGROUND

• Ford JD, Hawke J, Alessi S, Ledgerwood D, Petry N. Psychological trauma and PTSD symptoms as predictors of substance dependence treatment outcomes. Behav Res Ther. 2007 Oct;45(10):2417-31. doi: 10.1016/j.brat.2007.04.001. Epub 2007 Apr 19.

  PMID: 17531193 BACKGROUND

• Mauritz MW, Goossens PJ, Draijer N, van Achterberg T. Prevalence of interpersonal trauma exposure and trauma-related disorders in severe mental illness. Eur J Psychotraumatol. 2013;4. doi: 10.3402/ejpt.v4i0.19985. Epub 2013 Apr 8.

  PMID: 23577228 BACKGROUND

• Novo Navarro P, Landin-Romero R, Guardiola-Wanden-Berghe R, Moreno-Alcazar A, Valiente-Gomez A, Lupo W, Garcia F, Fernandez I, Perez V, Amann BL. 25 years of Eye Movement Desensitization and Reprocessing (EMDR): The EMDR therapy protocol, hypotheses of its mechanism of action and a systematic review of its efficacy in the treatment of post-traumatic stress disorder. Rev Psiquiatr Salud Ment (Engl Ed). 2018 Apr-Jun;11(2):101-114. doi: 10.1016/j.rpsm.2015.12.002. Epub 2016 Feb 11. English, Spanish.

  PMID: 26877093 BACKGROUND

• Novo P, Landin-Romero R, Radua J, Vicens V, Fernandez I, Garcia F, Pomarol-Clotet E, McKenna PJ, Shapiro F, Amann BL. Eye movement desensitization and reprocessing therapy in subsyndromal bipolar patients with a history of traumatic events: a randomized, controlled pilot-study. Psychiatry Res. 2014 Sep 30;219(1):122-8. doi: 10.1016/j.psychres.2014.05.012. Epub 2014 May 15.

  PMID: 24880581 BACKGROUND

• Oquendo M, Brent DA, Birmaher B, Greenhill L, Kolko D, Stanley B, Zelazny J, Burke AK, Firinciogullari S, Ellis SP, Mann JJ. Posttraumatic stress disorder comorbid with major depression: factors mediating the association with suicidal behavior. Am J Psychiatry. 2005 Mar;162(3):560-6. doi: 10.1176/appi.ajp.162.3.560.

  PMID: 15741474 BACKGROUND

• Palmier-Claus JE, Berry K, Bucci S, Mansell W, Varese F. Relationship between childhood adversity and bipolar affective disorder: systematic review and meta-analysis. Br J Psychiatry. 2016 Dec;209(6):454-459. doi: 10.1192/bjp.bp.115.179655. Epub 2016 Oct 6.

  PMID: 27758835 BACKGROUND

• Rosenberg SD, Lu W, Mueser KT, Jankowski MK, Cournos F. Correlates of adverse childhood events among adults with schizophrenia spectrum disorders. Psychiatr Serv. 2007 Feb;58(2):245-53. doi: 10.1176/ps.2007.58.2.245.

  PMID: 17287383 BACKGROUND

• van den Berg DP, de Bont PA, van der Vleugel BM, de Roos C, de Jongh A, Van Minnen A, van der Gaag M. Prolonged exposure vs eye movement desensitization and reprocessing vs waiting list for posttraumatic stress disorder in patients with a psychotic disorder: a randomized clinical trial. JAMA Psychiatry. 2015 Mar;72(3):259-67. doi: 10.1001/jamapsychiatry.2014.2637.

  PMID: 25607833 BACKGROUND

• Charlson FJ, Baxter AJ, Dua T, Degenhardt L, Whiteford HA, Vos T. Excess Mortality from Mental, Neurological, and Substance Use Disorders in the Global Burden of Disease Study 2010. In: Patel V, Chisholm D, Dua T, Laxminarayan R, Medina-Mora ME, editors. Mental, Neurological, and Substance Use Disorders: Disease Control Priorities, Third Edition (Volume 4). Washington (DC): The International Bank for Reconstruction and Development / The World Bank; 2016 Mar 14. Chapter 3. Available from http://www.ncbi.nlm.nih.gov/books/NBK361935/

  PMID: 27227239 BACKGROUND

• Hyman S, Parikh R, Collins PY, Patel V. Adult Mental Disorders. In: Patel V, Chisholm D, Dua T, Laxminarayan R, Medina-Mora ME, editors. Mental, Neurological, and Substance Use Disorders: Disease Control Priorities, Third Edition (Volume 4). Washington (DC): The International Bank for Reconstruction and Development / The World Bank; 2016 Mar 14. Chapter 4. Available from http://www.ncbi.nlm.nih.gov/books/NBK361952/

  PMID: 27227248 BACKGROUND

MeSH Terms

Conditions

Mental Disorders; Psychological Trauma

Interventions

Eye Movement Desensitization Reprocessing; Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ana Moreno-Alcázar, PhD

  Parc de Salut Mar; Fundación IMIM; CIBERSAM.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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.

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: September 10, 2018
• Study Start: February 1, 2019
• Primary Completion: August 8, 2022
• Study Completion: August 8, 2022
• Last Updated: December 2, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)