Reconsolidation and EMDR

PTSD Clinical Trial

Official title:

Blocking Memory Reconsolidation by Eye Movement Desensitization and Reprocessing (EMDR)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02572830
• Other study ID #: F-86401-09-01
• Status: Completed
• Phase: N/A
• Start date: December 31, 2015
• Est. completion date: May 7, 2017

Study information

• Verified date: May 2018
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: May 7, 2017
• Est. primary completion date: May 7, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• PTSD

Intervention

Behavioral:
• Delayed Bilateral Eye Movements
Bilateral Eye Movements followed by a 10 min delay after reactivation of fear-memory.
• 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.

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Department of Psychiatry and Psychotherapy	Zurich	ZH

Sponsors (3)

Lead Sponsor	Collaborator
University of Zurich	Harvard Medical School, Massachusetts General Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin conductance (SC) response		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	Blood oxygenation level dependent (BOLD) response		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)