Back to resultsExtension of EMDR vs. PC For Motor Vehicle Accident Trauma
Primary Purpose
Trauma, Psychological, Motor Vehicle Accident
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EMDR-based Flash technique
PC-based Flash technique
Sponsored by
About this trial
This is an interventional treatment trial for Trauma, Psychological
Eligibility Criteria
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
Sites / Locations
- Trauma Institute & Child Trauma InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Eye movement desensitization and reprocessing (EMDR) arm
Progressive counting (PC) arm
Arm Description
Outcomes
Primary Outcome Measures
Change in SUDS following treatment
Subjective Units of Distress Scale
Change in PRS following treatment
Problem Rating Scale
Change in PDS following treatment
PTSD Diagnostic Scale
Secondary Outcome Measures
Full Information
NCT ID
NCT03271411
First Posted
August 31, 2017
Last Updated
September 4, 2017
Sponsor
Trauma Institute & Child Trauma Institute
1. Study Identification
Unique Protocol Identification Number
NCT03271411
Brief Title
Extension of EMDR vs. PC For Motor Vehicle Accident Trauma
Official Title
Extension of EMDR vs. PC For Motor Vehicle Accident Trauma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 30, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trauma Institute & Child Trauma Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Psychological, Motor Vehicle Accident
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Eye movement desensitization and reprocessing (EMDR) arm
Arm Type
Experimental
Arm Title
Progressive counting (PC) arm
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
EMDR-based Flash technique
Intervention Description
Initial EMDR session (with Flash technique) of up to three hours; about one week later, follow-up session of up to one hour
Intervention Type
Behavioral
Intervention Name(s)
PC-based Flash technique
Intervention Description
Initial PC session (with Flash technique) of up to three hours; about one week later, follow-up session of up to one hour
Primary Outcome Measure Information:
Title
Change in SUDS following treatment
Description
Subjective Units of Distress Scale
Time Frame
Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment
Title
Change in PRS following treatment
Description
Problem Rating Scale
Time Frame
Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment
Title
Change in PDS following treatment
Description
PTSD Diagnostic Scale
Time Frame
Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ricky Greenwald, PsyD
Phone
413-774-2340
Email
cti@childtrauma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricky Greenwald, PsyD
Organizational Affiliation
Trauma Institute & Child Trauma Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Trauma Institute & Child Trauma Institute
City
Northampton
State/Province
Massachusetts
ZIP/Postal Code
01060
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ricky Greenwald, PsyD
Phone
413-774-2340
Email
cti@childtrauma.com
12. IPD Sharing Statement
Learn more about this trial
Extension of EMDR vs. PC For Motor Vehicle Accident Trauma
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