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Reconsolidation and EMDR

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ClinicalTrials.gov Identifier: NCT02572830
Recruitment Status : Completed
First Posted : October 9, 2015
Last Update Posted : May 8, 2018
Sponsor:
Collaborators:
Massachusetts General Hospital
Harvard Medical School
Information provided by (Responsible Party):
Christoph Müller-Pfeiffer, University of Zurich

Brief Summary:
Blocking of reconsolidation by pharmacological or behavioral means offers the therapeutic possibility of weakening traumatic memories in posttraumatic stress disorder (PTSD). Two reconsolidation-based interventions, propranolol and extinction learning, have been shown to weaken fear memories in human healthy subjects. However, the success of these interventions seems to be limited to weak conditioned fear memories. This calls for new, potentially more efficacious, interventions to be tested. Bilateral eye movements seem to be a promising candidate intervention for blocking reconsolidation due to the compelling evidence of Eye Movement Desensitization and Reprocessing as effective treatment in PTSD. The investigators' aim is to test bilateral eye movements as an active reconsolidation-blocking intervention in an optimized differential fear conditioning procedure that the investigators have recently developed. This novel experimental assay creates stronger fear memories in healthy individuals.

Condition or disease Intervention/treatment Phase
PTSD Behavioral: Delayed Bilateral Eye Movements Behavioral: Undelayed Bilateral Eye Movement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Blocking Memory Reconsolidation by Eye Movement Desensitization and Reprocessing (EMDR)
Actual Study Start Date : December 31, 2015
Actual Primary Completion Date : May 7, 2017
Actual Study Completion Date : May 7, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Experimental: Delayed Bilateral Eye Movements
Delayed Bilateral Eye Movements after reactivation of fear-memory.
Behavioral: Delayed Bilateral Eye Movements
Bilateral Eye Movements followed by a 10 min delay after reactivation of fear-memory.

Active Comparator: Undelayed Bilateral Eye Movements
Undelayed Bilateral Eye Movements after reactivation of fear-memory.
Behavioral: Undelayed Bilateral Eye Movement
Bilateral Eye Movements followed by no delay after reactivation of fear-memory. reactivation of the fear memory trace during which the reactivated memory is assumed to be in a labile state.




Primary Outcome Measures :
  1. Skin conductance (SC) response [ Time Frame: Change from Day 1 (acquisition) fear conditioned SC response at day 3 (testing of renewal, reinstatement) and day 30 follow-up (testing of spontaneous recovery/renewal, savings) ]

Secondary Outcome Measures :
  1. Blood oxygenation level dependent (BOLD) response [ Time Frame: Change from Day 1 (acquisition) fear conditioned BOLD response at day 3 (testing of renewal, reinstatement) and day 30 follow-up (testing of spontaneous recovery/renewal, savings) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female between 18 years and 60 years of age
  • Presence of a manageable, nonphobic fear of spiders as determined by scores above the mean (male: 8.06; female: 10.46) on the German adapted Spider Phobia Questionnaire (SPQ; 38) and phobia criteria extracted from the Structured Clinical Interview for DSM-5 Axis I Disorders (SCID-I; 39)
  • Signed Informed Consent after being informed

Exclusion Criteria:

  • Current or past neurological or other medical condition affecting the brain
  • Current use of any medication (except contraceptives, herbal medicine)
  • Known or suspected non-compliance, drug or alcohol misuse
  • Presence of any current psychiatric disorders determined by the Mini International Neuropsychiatric Interview (MINI; 40)
  • Inability to follow the procedures of the study, e.g. due to language problems
  • No SC response to physical (Valsalva maneuver), psychological (mental arithmetic) and/or auditive (handclapping) stressor

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): NCT02572830


Locations
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Switzerland
University Hospital Zurich, Department of Psychiatry and Psychotherapy
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Massachusetts General Hospital
Harvard Medical School
Investigators
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Principal Investigator: Christoph Mueller-Pfeiffer, MD University Hospital of Zurich, Department of Psychiatry and Psychotherapy
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Responsible Party: Christoph Müller-Pfeiffer, PD. Dr., University of Zurich
ClinicalTrials.gov Identifier: NCT02572830    
Other Study ID Numbers: F-86401-09-01
First Posted: October 9, 2015    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018
Keywords provided by Christoph Müller-Pfeiffer, University of Zurich:
Reconsolidation
EMDR
PTSD