Ignite Creation Date:
2024-05-05 @ 10:53 PM
Last Modification Date:
2024-10-26 @ 10:25 AM
Study NCT ID:
NCT01209377
Status:
UNKNOWN
Last Update Posted:
2010-09-27
First Post:
2010-06-17
Brief Title:
Study of Eye Movement Desensitization and Reprocessing EMDR Working Mechanism
Sponsor:
Technical University of Munich
Organization:
Technical University of Munich
Study Overview
Official Title:
Randomized Controlled Study of Eye Movement Desensitization and Reprocessing EMDR Working Mechanism
Status:
UNKNOWN
Status Verified Date:
2010-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 CAPSas assessed pre-treatment and after treatment max 8 sessions of psychotherapy
The following hypothesis are investigated in the study
1 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
2 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
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 CAPSas assessed pre-treatment and after treatment max 8 sessions of psychotherapy
The following hypothesis are investigated in the study
1 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
2 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None