- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03271359
EMDR vs. PC For Motor Vehicle Accident Trauma
September 4, 2017 updated by: Trauma Institute & Child Trauma Institute
This is a randomized clinical trial comparing eye movement desensitization and reprocessing (EMDR) to progressive counting (PC) for volunteers from the community who are distressed by the memory of a motor vehicle accident.
Participants will be assigned to the geographically nearest therapist, and then randomized to treatment condition.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Northampton, Massachusetts, United States, 01060
- Trauma Institute & Child Trauma Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- adult reporting distress related to motor vehicle accident-related trauma
- English-speaking
Exclusion Criteria:
- already in therapy in which the memory of interest is being actively addressed with a structured/focused trauma resolution method
- any obvious/urgent need for more comprehensive psychotherapy (based on initial screening interview)
- any indication of instability during interactions prior to the therapy session
- an average score on the Dissociative Experiences Scale of 30 or greater, if (as per follow-up questions) indicating a likely dissociative disorder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Eye movement desensitization and reprocessing (EMDR) arm
|
Initial EMDR session of up to three hours; about one week later, follow-up session of up to one hour
|
EXPERIMENTAL: Progressive counting (PC) arm
|
Initial PC session of up to three hours; about one week later, follow-up session of up to one hour
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in SUDS following treatment
Time Frame: Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment
|
Subjective Units of Distress Scale
|
Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment
|
Change in PRS following treatment
Time Frame: Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment
|
Problem Rating Scale
|
Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment
|
Change in PDS following treatment
Time Frame: Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment
|
PTSD Diagnostic Scale
|
Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ricky Greenwald, Trauma Institute & Child Trauma Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 5, 2014
Primary Completion (ANTICIPATED)
December 31, 2017
Study Completion (ANTICIPATED)
December 31, 2017
Study Registration Dates
First Submitted
August 31, 2017
First Submitted That Met QC Criteria
August 31, 2017
First Posted (ACTUAL)
September 5, 2017
Study Record Updates
Last Update Posted (ACTUAL)
September 7, 2017
Last Update Submitted That Met QC Criteria
September 4, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-GRE-3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Trauma, Psychological
-
Cantonal Hospital of St. GallenCompleted
-
Victor CarrionUniversity of South Carolina; Iowa State University; University of San Diego; Pure...CompletedStress, Psychological | Trauma, Psychological
-
Hôpital le VinatierNot yet recruitingTrauma, Psychological
-
Dominique JANUELRecruiting
-
University of OtagoRecruitingTrauma, Psychological | EarthquakeNew Zealand
-
Nottingham Trent UniversityNot yet recruitingTrauma, Psychological | Legal Education
-
Trauma Institute & Child Trauma InstituteGratis FoundationUnknownTrauma, Psychological | Conflict, InterparentalUnited States
-
University of SalfordCompletedTrauma, PsychologicalUnited Kingdom
-
Fondation LenvalRecruitingAnxiety Disorders | Stress, Psychological | Trauma, PsychologicalFrance
-
University of OtagoCanterbury Medical Research FoundationNot yet recruitingPsychological Distress | Trauma, Psychological | Emotional ProblemNew Zealand
Clinical Trials on EMDR
-
Erasmus Medical CenterNot yet recruitingAnxiety and Fear
-
Medisch Spectrum TwenteLeiden University Medical Center; University of TwenteNot yet recruiting
-
University of PisaCompletedObsessive-Compulsive Disorder | Post-traumatic Stress Disorder | Guilt | Adult ALL | Shame | DisgustItaly
-
University Hospital, ToursInstitut National de la Santé Et de la Recherche Médicale, FranceCompletedDepression | Burnout, Professional | Post Traumatic Stress DisorderFrance
-
Ciclo de MutaçãoSao Jose do Rio Preto Medical SchoolCompleted
-
ArkinAmsterdam UMC, location VUmc; Ziekenhuis Amstelland; Meander Medisch Centrum; Sinai... and other collaboratorsRecruitingPosttraumatic Stress Disorder (PTSD) | Borderline Personality Disorder (BPD)Netherlands
-
University of PisaCompletedCognitive Change | Child, Only | Distress, Emotional | Narration | Memory DysfunctionItaly
-
Quaid-e-Azam UniversityRecruiting
-
Mersin UniversityRecruiting