Reconsolidation and EMDR

NCT02572830 | Completed

• 1 other identifier: F-86401-09-01
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

PTSD

Keywords

Reconsolidation; EMDR; PTSD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (2)

Delayed Bilateral Eye Movements

EXPERIMENTAL

Delayed Bilateral Eye Movements after reactivation of fear-memory.

Behavioral: Delayed Bilateral Eye Movements

Undelayed Bilateral Eye Movements

ACTIVE COMPARATOR

Undelayed Bilateral Eye Movements after reactivation of fear-memory.

Behavioral: Undelayed Bilateral Eye Movement

Interventions

Delayed Bilateral Eye Movements BEHAVIORAL

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

Delayed Bilateral Eye Movements

Undelayed Bilateral Eye Movement BEHAVIORAL

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.

Undelayed Bilateral Eye Movements

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• Massachusetts General Hospital: collaborator
• Harvard Medical School (HMS and HSDM): collaborator

Study Sites (1)

University Hospital Zurich, Department of Psychiatry and Psychotherapy

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Christoph Mueller-Pfeiffer, MD

  University Hospital of Zurich, Department of Psychiatry and Psychotherapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD. Dr.

Study Record Dates

• First Submitted: October 4, 2015
• First Posted: October 9, 2015
• Study Start: December 31, 2015
• Primary Completion: May 7, 2017
• Study Completion: May 7, 2017
• Last Updated: May 8, 2018

Record last verified: 2018-05

Locations

CH (1)