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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03271359
Other study ID # 2015-GRE-3
Secondary ID
Status Active, not recruiting
Phase N/A
First received August 31, 2017
Last updated September 4, 2017
Start date January 5, 2014
Est. completion date December 31, 2017

Study information

Verified date September 2017
Source Trauma Institute & Child Trauma Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 40
Est. completion date December 31, 2017
Est. primary completion date December 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Behavioral:
EMDR
Initial EMDR session of up to three hours; about one week later, follow-up session of up to one hour
PC
Initial PC session of up to three hours; about one week later, follow-up session of up to one hour

Locations

Country Name City State
United States Trauma Institute & Child Trauma Institute Northampton Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Trauma Institute & Child Trauma Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in SUDS following treatment Subjective Units of Distress Scale Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment
Primary Change in PRS following treatment Problem Rating Scale Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment
Primary Change in PDS following treatment PTSD Diagnostic Scale Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment
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