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EMDR vs Supportive Therapy in Relapse Prevention in Traumatized Bipolar Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02634372
Recruitment Status : Unknown
Verified August 2016 by Benedikt Amann, FIDMAG Germanes Hospitalàries.
Recruitment status was:  Not yet recruiting
First Posted : December 18, 2015
Last Update Posted : August 9, 2016
Sponsor:
Collaborators:
Hospital Clinic of Barcelona
Hospital del Mar
Hospital Universitari de Bellvitge
Instituto de Salud Carlos III
Centro de Investigación Biomédica en Red de Salud Mental
Information provided by (Responsible Party):
Benedikt Amann, FIDMAG Germanes Hospitalàries

Brief Summary:
The purpose of this study is to determine whether EMDR (vs supportive therapy) is effective in relapse prevention over an observational period of 2 years in bipolar patients with a history of traumatic events.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Behavioral: EMDR therapy Behavioral: Supportive Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Single-blind, Randomized Controlled Comparison of EMDR Versus Supportive Therapy in Affective Relapse Prevention in Bipolar Patients With a History of Trauma
Study Start Date : March 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
Experimental: EMDR Therapy
EMDR: 20 individual sessions 60 minutes each for 6 months
Behavioral: EMDR therapy
EMDR: We designed a specific EMDR Bipolar Protocol which consists of a detailed interview with respect to traumatic events, the treatment of those with the EMDR standard protocol, and five new specific bipolar adapted EMDR protocols focusing on adherence, insight, de-idealisation of manic symptoms, prodromal symptoms and moodstabilization.

Active Comparator: Supportive therapy
Supportive therapy: 20 individual sessions 60 minutes each for 6 months.
Behavioral: Supportive Therapy
Supportive therapy: Therapists adopt a client-centred focus, meaning that whatever problems the patient presents will be dealt with by providing emotional support and general advise. If no specific topic is mentioned by the patient, information about bipolar disorder and medication will be delivered by the therapist without referring to written or any other material.




Primary Outcome Measures :
  1. Number of depressive, hypomanic, manic or mixed episodes [ Time Frame: Change of relapses from baseline to visits at 6, 12 and 24 months ]
    Affective relapses are defined as: Depressive relapse: score>18 in the BDRS, and a score>3 in the CGI-BP-M, depressive subscale. Hypomanic relapse: a YMRS score between 7 and 20, and a score of 3 or 4 in the CGI-BP-M, the manic subscale. Manic relapse: a YMRS score of >20, and the CGI-BP-M, the manic subscale, score>4. Mixed relapse: a BDRS score>10 in the mixed subscale (max. 15), and a score >4 in the CGI-BP-M, depressive and manic subscales.


Secondary Outcome Measures :
  1. Depressive symptoms [ Time Frame: Change from baseline in depressive symptoms at 3, 6, 12 and 24 months ]
    To measure changes in depressive symptoms we will use the BDRS, and the CGI-BP-M, the depressive subscale.

  2. (Hypo)manic symptoms [ Time Frame: Change from baseline in (hypo)manic symptoms at 3, 6, 12 and 24 months ]
    To measure changes in (hypo)manic symptoms we will use the YMRS and the CGI-BP-M, the manic subscale.

  3. Mixed symptoms [ Time Frame: Change from baseline in mixed symptoms at 3, 6, 12 and 24 months ]
    To measure changes in mixed symptoms we will use the YMRS, the BDRS (mixed subscale) and the CGI-BP-M, the depressive and manic subscale.

  4. Trauma associated symptoms [ Time Frame: Change from baseline in trauma symptoms at 3, 6, 12 and 24 months ]
    To measure changes in trauma associated symptoms, the CAPS, IES, TLEQ and DEQ will be used.

  5. Functioning [ Time Frame: Change from baseline in functioning at 3, 6, 12 and 24 months ]
    To measure changes in functioning the FAST will be used.

  6. Cognitive impairment [ Time Frame: Change from baseline in cognition at 3, 6, 12 and 24 months ]
    To measure changes in cognition the SCIP will be used.

  7. Social cognition and emotional intelligence [ Time Frame: Change from baseline in cognition at 3, 6, 12 and 24 months ]
    To measure changes in social cognition and emotional intelligence the MSCEIT will be used.



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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:

  • Patients fulfill diagnosis of bipolar I or II disorder, following DSM-IV-RT criteria
  • Outpatients
  • History of 2 to 6 affective episodes in previous year
  • Patients are included in the study 1) in euthymia, defined as Bipolar Depression Rating Scale (BDRS) <8 and Young Mania Rating Scale (YMRS) <8 or 2) with subsyndromal symptoms, defined as BDRS ≥8 and <14 and/or YMRS ≥8 and <12
  • Patients suffered at least from one traumatic event, evaluated by the Distressing Event Scale, Traumatic Life Events Questionnaire, Impact of Event Scale and Subjects Units of Distress.

Exclusion Criteria:

  • Neurological disease
  • Currently in a manic phase (YMRS>18), mixed phase (BDRS≥10 in mixed subscale of BDRS, max.: 15) or depressive phase (BDRS >18)
  • Acute suicidal plans
  • Substance Use Disorder within last 3 months (except of nicotine abuse/dependency)
  • Trauma focused therapy within last 12 months.

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): NCT02634372


Contacts
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Contact: Benedikt L Amann, MD +34-936529999 ext 1490 benedikt.amann@gmail.com

Locations
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Spain
FIDMAG
Barcelona, Spain, 08035
Sponsors and Collaborators
FIDMAG Germanes Hospitalàries
Hospital Clinic of Barcelona
Hospital del Mar
Hospital Universitari de Bellvitge
Instituto de Salud Carlos III
Centro de Investigación Biomédica en Red de Salud Mental
Investigators
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Principal Investigator: Benedikt L Amann, MD FIDMAG Research Foundation
Publications:
Purdo SE: The Screen for Cognitive Impairment in Psychiatry (SCIP): Instructions and three alternate forms. PNLInc, Edmonton, Alberta, 2005.
Amann BL, Batalla R, Blanch V, Capellades D, Carvajal MJ, Fernández I, García F, Lupo W, Ponte M, Sánchez J, Sanfiz J, Santed A and Luber M: The EMDR Therapy Protocol for Bipolar Disorder. In M. Luber (Ed.), Eye Movement Desensitization and Reprocessing (EMDR) Scripted Protocols and Summary Sheets: Treating trauma, anxiety and mood-related conditions. New York: Springer, 2015 (p 223-287).
Weiss DS, Marmar CR. The Impact of Event Scale - Revised, Assessing Psychological Trauma and PTSD. Guilford Press, New York, 1997 pp.399-411

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Benedikt Amann, Senior Research fellow, FIDMAG Germanes Hospitalàries
ClinicalTrials.gov Identifier: NCT02634372    
Other Study ID Numbers: PI15/02242
First Posted: December 18, 2015    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: August 2016
Keywords provided by Benedikt Amann, FIDMAG Germanes Hospitalàries:
Bipolar Disorder
Traumatic event
Eye Movement Desensitization Reprocessing
Supportive therapy
Relapse prevention
Additional relevant MeSH terms:
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Recurrence
Bipolar Disorder
Disease Attributes
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders