- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02572830
Reconsolidation and EMDR
May 2, 2018 updated by: Christoph Müller-Pfeiffer, University of Zurich
Blocking Memory Reconsolidation by Eye Movement Desensitization and Reprocessing (EMDR)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
160
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
ZH
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Zurich, ZH, Switzerland, 8091
- University Hospital Zurich, Department of Psychiatry and Psychotherapy
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Delayed Bilateral Eye Movements
Delayed Bilateral Eye Movements after reactivation of fear-memory.
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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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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)
|
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
Outcome Measure |
Time Frame |
|---|---|
|
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)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christoph Mueller-Pfeiffer, MD, University Hospital of Zurich, Department of Psychiatry and Psychotherapy
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 31, 2015
Primary Completion (Actual)
May 7, 2017
Study Completion (Actual)
May 7, 2017
Study Registration Dates
First Submitted
October 4, 2015
First Submitted That Met QC Criteria
October 7, 2015
First Posted (Estimate)
October 9, 2015
Study Record Updates
Last Update Posted (Actual)
May 8, 2018
Last Update Submitted That Met QC Criteria
May 2, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- F-86401-09-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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