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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
PC
Sponsored by
Trauma Institute & Child Trauma Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trauma, Psychological

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Institute

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

First Posted
August 31, 2017
Last Updated
September 4, 2017
Sponsor
Trauma Institute & Child Trauma Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03271359
Brief Title
EMDR vs. PC For Motor Vehicle Accident Trauma
Official Title
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
January 5, 2014 (Actual)
Primary Completion Date
December 31, 2017 (Anticipated)
Study Completion Date
December 31, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trauma Institute & Child Trauma Institute

4. Oversight

5. Study Description

Brief Summary
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.

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
40 (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
Intervention Description
Initial EMDR session of up to three hours; about one week later, follow-up session of up to one hour
Intervention Type
Behavioral
Intervention Name(s)
PC
Intervention Description
Initial PC session 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricky Greenwald
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

12. IPD Sharing Statement

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EMDR vs. PC For Motor Vehicle Accident Trauma

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