PTSDNCT02572830
Reconsolidation and EMDR
A study testing Delayed Bilateral Eye Movements and Undelayed Bilateral Eye Movement in people with PTSD, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- PTSD
- What is being tested?
- Delayed Bilateral Eye Movements and Undelayed Bilateral Eye Movement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSwitzerland
- Study dates
- 31 Dec 2015to 7 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Department of Psychiatry and Psychotherapy
Zurich, Canton of Zurich, 8091
About this study
Official title: 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.
- Conditions
- PTSD
- Being tested
- Delayed Bilateral Eye Movements, Undelayed Bilateral Eye Movement
- Keywords
- Reconsolidation, EMDR, PTSD
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed Bilateral Eye MovementsBehavioural
Bilateral Eye Movements followed by a 10 min delay after reactivation of fear-memory.
Undelayed Bilateral Eye MovementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Delayed Bilateral Eye Movements | Experimental | Delayed Bilateral Eye Movements after reactivation of fear-memory. Receives: Behavioral: Delayed Bilateral Eye Movements |
| Undelayed Bilateral Eye Movements | Active comparator | Undelayed Bilateral Eye Movements after reactivation of fear-memory. Receives: Behavioral: Undelayed Bilateral Eye Movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin conductance (SC) response
Measured: 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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study start31 Dec 2015
- Primary completion7 May 2017
- Study completion7 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Harvard Medical School (HMS and HSDM)
- Responsible party
- Principal investigator, Christoph Müller-Pfeiffer, University of Zurich
- Investigators
- Christoph Mueller-Pfeiffer, MD, Principal investigator, University Hospital of Zurich, Department of Psychiatry and Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572830
- Sponsor's protocol ID
- F-86401-09-01
- Status last verified
- May 2018
- First submitted
- 4 Oct 2015
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blocking Memory Reconsolidation by Eye Movement Desensitization and Reprocessing (EMDR)
- ClinicalTrials.gov ID
- NCT02572830
- Acronym / sponsor ID
- F-86401-09-01
- Conditions
- PTSD
- Keywords
- Reconsolidation, EMDR, PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Harvard Medical School (HMS and HSDM)
- Study start
- 31 Dec 2015 (actual)
- Primary completion
- 7 May 2017 (actual)
- Study completion
- 7 May 2017 (actual)
- First posted
- 9 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed Bilateral Eye Movements | Experimental | Behavioral: Delayed Bilateral Eye MovementsDelayed Bilateral Eye Movements after reactivation of fear-memory. |
| Undelayed Bilateral Eye Movements | Active comparator | Behavioral: Undelayed Bilateral Eye MovementUndelayed Bilateral Eye Movements after reactivation of fear-memory. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delayed Bilateral Eye MovementsBilateral Eye Movements followed by a 10 min delay after reactivation of fear-memory. | Behavioural | Delayed Bilateral Eye Movements |
| Undelayed Bilateral Eye MovementBilateral 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. | Behavioural | Undelayed Bilateral Eye Movements |
Primary outcome
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)
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Mueller-Pfeiffer, MD principal investigator
University Hospital of Zurich, Department of Psychiatry and Psychotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delayed Bilateral Eye Movements and Undelayed Bilateral Eye Movement in people with PTSD, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2018.