- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03271398
Intensive Therapy Archival Research
September 4, 2017 updated by: Trauma Institute & Child Trauma Institute
This is an internal treatment evaluation to determine whether eye movement desensitization and reprocessing (EMDR) or progressive counting (PC) should become the preferred trauma treatment for the investigator's clients.
The investigator is using routine/existing in-house measures and case files to track symptom reduction, trauma treatment time, rate of treatment switching (from EMDR to PC or vice versa), and rate of trauma treatment refusal.
This is retrospective as well as prospective archival research.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
1200
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All participants in the Trauma Institute & Child Trauma Institute Victims of Crime program will be included.
Description
Inclusion Criteria:
- Victims of crimes, including assault, rape, robbery, intimate partner violence, child abuse, kidnapping, vehicular homicide, and suicide
- Witnesses and family members of victims
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Adult victims of sexual assault
|
Eye movement desensitization and reprocessing (intensive format)
Progressive counting (intensive format)
|
|
Children who have been exposed to domestic abuse
|
Eye movement desensitization and reprocessing (intensive format)
Progressive counting (intensive format)
|
|
Women with perinatal emotional complications
|
Eye movement desensitization and reprocessing (intensive format)
Progressive counting (intensive format)
|
|
Teens with behavior problems and histories of abuse
|
Eye movement desensitization and reprocessing (intensive format)
Progressive counting (intensive format)
|
|
Veterans with military-related trauma
|
Eye movement desensitization and reprocessing (intensive format)
Progressive counting (intensive format)
|
|
Survivors of intimate partner violence
|
Eye movement desensitization and reprocessing (intensive format)
Progressive counting (intensive format)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 TSI-2 following treatment
Time Frame: Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment
|
Trauma Symptom Inventory-2
|
Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment
|
|
Change in TSCC following treatment
Time Frame: Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment
|
Trauma Symptom Checklist for Children
|
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.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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 2, 2017
Primary Completion (Anticipated)
December 31, 2022
Study Completion (Anticipated)
December 31, 2022
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
- 2017-1001
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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