NCT03271359

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2014

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 5, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

September 7, 2017

Status Verified

September 1, 2017

Enrollment Period

4 years

First QC Date

August 31, 2017

Last Update Submit

September 4, 2017

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in SUDS following treatment

    Subjective Units of Distress Scale

    Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment

  • Change in PRS following treatment

    Problem Rating Scale

    Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment

  • Change in PDS following treatment

    PTSD Diagnostic Scale

    Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment

Study Arms (2)

Eye movement desensitization and reprocessing (EMDR) arm

EXPERIMENTAL
Behavioral: EMDR

Progressive counting (PC) arm

EXPERIMENTAL
Behavioral: PC

Interventions

EMDRBEHAVIORAL

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

Eye movement desensitization and reprocessing (EMDR) arm
PCBEHAVIORAL

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

Progressive counting (PC) arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult reporting distress related to motor vehicle accident-related trauma
  • English-speaking

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trauma Institute & Child Trauma Institute

Northampton, Massachusetts, 01060, United States

Location

MeSH Terms

Conditions

Psychological Trauma

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Ricky Greenwald

    Trauma Institute & Child Trauma Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2017

First Posted

September 5, 2017

Study Start

January 5, 2014

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

September 7, 2017

Record last verified: 2017-09

Locations