Post-Traumatic Stress DisorderNCT01209377
Study of Eye Movement Desensitization and Reprocessing (EMDR) Working Mechanism
A study testing standard, fixed and no focus in people with Post-Traumatic Stress Disorder, run by Technical University of Munich at 1 site in Germany.
Trial summary
EMDR (Eye Movement Desensitization and Reprocessing) is an exposure-based procedure for the treatment of patients with post-traumatic stress disorder (PTSD). Although the efficiency of EMDR-treatment is empirically proven, it remains unclear whether the bilateral stimulation triggered via eye movements has specific… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- standard, fixed and no focus
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2010to Apr 2012
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- the participant is able to reduce stress symptoms
- no actual contact to offender
Who cannot join
- drug or alcohol addiction
- inability to tell about the traumatic events
- cardiac problems
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Technische Universität München
Munich, Germany, 81675
Martin Sack, MD, +498941404312, m.sack@tum.de
Julia Körner, PHD, +498941406435, j.koerner@tum.de
About this study
Official title: Randomized Controlled Study of Eye Movement Desensitization and Reprocessing (EMDR) Working Mechanism
EMDR (Eye Movement Desensitization and Reprocessing) is an exposure-based procedure for the treatment of patients with post-traumatic stress disorder (PTSD). Although the efficiency of EMDR-treatment is empirically proven, it remains unclear whether the bilateral stimulation triggered via eye movements has specific effects on treatment outcome. Hypothesis explaining the efficacy of the EMDR treatment are: focussing on the moving hand triggers an orientation reaction, and the duality of alertness focus during trauma exposition causes a distraction of the traumatic topic.
Within a randomized controlled study 120 patients will be treated during 8 therapeutical sessions with EMDR with bilateral stimulation or one of two control conditions: EMDR without bilateral stimulation (eyes on a fixed, unmoving hand) and exposition without any visual stimuli to focus attention on. Primary outcome are scores on an interview measure for PTSD symptoms (Clinician Administered PTSD Scale (CAPS))as assessed pre-treatment and after treatment (max 8 sessions of psychotherapy).
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The following hypothesis are investigated in the study:
- EMDR treatment with bilateral stimulation through eye movements will be followed significant larger reduction in CAPS compared with EMDR treatment without bilateral stimulation (specific treatment effect of eye movements)
- EMDR with eyes fixed will be followed by a significant larger reduction in CAPS compared with EMDR without external focus (specific treatment effect of distraction)
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- standard, fixed, no focus, EMDR
- Keywords
- standard, fixed, no focus, EMDR treatment with bilateral stimulation via eye movement, EMDR treatment with fixed eyes, Trauma exposition without external stimulus
- 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.
standardBehavioural
EMDR treatment with bilateral stimulation via eye movement
fixedBehavioural
EMDR treatment with fixed eyes
no focusBehavioural
trauma exposure without external focus
EMDRProcedure or surgery
Eye Movement Desensitization and Reprocessing (EMDR)
| Study group | Role | What they receive |
|---|---|---|
| standard | Experimental | EMDR treatment with bilateral stimulation via eye movement Receives: Behavioral: standard; Procedure: EMDR |
| fixed | Experimental | EMDR treatment with eyes fixed Receives: Behavioral: fixed; Procedure: EMDR |
| no focus | Experimental | trauma exposition without external stimulus Receives: Behavioral: no focus; Procedure: EMDR |
What is being measured
The primary outcome is the main question the study is designed to answer.
CAPS-2: Clinical Administered PTSD Scale
Measured: 30 minutes
Secondary outcomes (1)
IES - Impact of Events Scale
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2010 (estimated)
- Study startApr 2010
- Primary completionJan 2012 (estimated)
- Study completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation, University of Giessen
- Investigators
- Martin Sack, PHD, Study director, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01209377
- Sponsor's protocol ID
- SA1475/2-1
- Status last verified
- Sep 2010
- First submitted
- 17 Jun 2010
- Last updated
- 27 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study of Eye Movement Desensitization and Reprocessing (EMDR) Working Mechanism
- ClinicalTrials.gov ID
- NCT01209377
- Acronym / sponsor ID
- SA1475/2-1
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- standard, fixed, no focus, EMDR treatment with bilateral stimulation via eye movement, EMDR treatment with fixed eyes, Trauma exposition without external stimulus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- German Research Foundation, University of Giessen
- Study start
- Apr 2010
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 27 Sep 2010 (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.
EMDR (Eye Movement Desensitization and Reprocessing) is an exposure-based procedure for the treatment of patients with post-traumatic stress disorder (PTSD). Although the efficiency of EMDR-treatment is empirically proven, it remains unclear whether the bilateral stimulation triggered via eye movements has specific effects on treatment outcome. Hypothesis explaining the efficacy of the EMDR treatment are: focussing on the moving hand triggers an orientation reaction, and the duality of alertness focus during trauma exposition causes a distraction of the traumatic topic.
Within a randomized controlled study 120 patients will be treated during 8 therapeutical sessions with EMDR with bilateral stimulation or one of two control conditions: EMDR without bilateral stimulation (eyes on a fixed, unmoving hand) and exposition without any visual stimuli to focus attention on. Primary outcome are scores on an interview measure for PTSD symptoms (Clinician Administered PTSD Scale (CAPS))as assessed pre-treatment and after treatment (max 8 sessions of psychotherapy).
The following hypothesis are investigated in the study:
- EMDR treatment with bilateral stimulation through eye movements will be followed significant larger reduction in CAPS compared with EMDR treatment without bilateral stimulation (specific treatment effect of eye movements)
- EMDR with eyes fixed will be followed by a significant larger reduction in CAPS compared with EMDR without external focus (specific treatment effect of distraction)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| standard | Experimental | Behavioral: standard, Procedure: EMDREMDR treatment with bilateral stimulation via eye movement |
| fixed | Experimental | Behavioral: fixed, Procedure: EMDREMDR treatment with eyes fixed |
| no focus | Experimental | Behavioral: no focus, Procedure: EMDRtrauma exposition without external stimulus |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- the participant is able to reduce stress symptoms
- no actual contact to offender
Key exclusion criteria (3 listed)
- drug or alcohol addiction
- inability to tell about the traumatic events
- cardiac 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 |
|---|---|---|
| standardEMDR treatment with bilateral stimulation via eye movement | Behavioural | standard |
| fixedEMDR treatment with fixed eyes | Behavioural | fixed |
| no focustrauma exposure without external focus | Behavioural | no focus |
| EMDREye Movement Desensitization and Reprocessing (EMDR) | Procedure or surgery | fixed, no focus, standard |
Primary outcome
CAPS-2: Clinical Administered PTSD Scale
Time frame: 30 minutes
1 secondary outcome
IES - Impact of Events Scale
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2010.
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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.
Martin Sack, PHD study director
Technical University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard, fixed and no focus in people with Post-Traumatic Stress Disorder, run by Technical University of Munich at 1 site in Germany.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Sep 2010. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Sack, MD (+498941404312, m.sack@tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CAPS-2: Clinical Administered PTSD Scale (time frame: 30 minutes). 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 27 Sep 2010.