- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03271411
Extension of EMDR vs. PC For Motor Vehicle Accident Trauma
September 4, 2017 updated by: Trauma Institute & Child Trauma Institute
This is an extension of 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.
The purpose of this extension is to add Phil Manfield's recently developed Flash technique as a precursor to both EMDR and PC, to see a) if that has any impact on participant retention, treatment effectiveness, or treatment efficiency; and b) if such impact is equivalent with EMDR and PC.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
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
- Recruiting
- 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
16 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 Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Eye movement desensitization and reprocessing (EMDR) arm
|
Initial EMDR session (with Flash technique) 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 (with Flash technique) 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.
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)
August 30, 2017
Primary Completion (Anticipated)
December 31, 2018
Study Completion (Anticipated)
December 31, 2018
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
- 2017-1002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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