Trauma, PsychologicalNCT03271398
Intensive Therapy Archival Research
An observational study of Trauma, Psychological, run by Trauma Institute & Child Trauma Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Trauma, Psychological
- What is being tested?
- EMDR and PC
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2017to 31 Dec 2022
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: All participants in the Trauma Institute \& Child Trauma Institute Victims of Crime program will be included.
Who may be able to join
- Victims of crimes, including assault, rape, robbery, intimate partner violence, child abuse, kidnapping, vehicular homicide, and suicide
- Witnesses and family members of victims
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Trauma Institute & Child Trauma Institute
Northampton, Massachusetts, 01060
Ricky Greenwald, PsyD, 413-774-2340, cti@childtrauma.com
About this study
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.
- Conditions
- Trauma, Psychological
- Being tested
- EMDR, PC
- Medical subject headings
- Psychological Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMDRBehavioural
Eye movement desensitization and reprocessing (intensive format)
PCBehavioural
Progressive counting (intensive format)
| Study group | Role | What they receive |
|---|---|---|
| Adult victims of sexual assault | Not described Receives: Behavioral: EMDR; Behavioral: PC | |
| Children who have been exposed to domestic abuse | Not described Receives: Behavioral: EMDR; Behavioral: PC | |
| Women with perinatal emotional complications | Not described Receives: Behavioral: EMDR; Behavioral: PC | |
| Teens with behavior problems and histories of abuse | Not described Receives: Behavioral: EMDR; Behavioral: PC | |
| Veterans with military-related trauma | Not described Receives: Behavioral: EMDR; Behavioral: PC | |
| Survivors of intimate partner violence | Not described Receives: Behavioral: EMDR; Behavioral: PC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in TSI-2 following treatment
Trauma Symptom Inventory-2
Measured: Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment
Change in TSCC following treatment
Trauma Symptom Checklist for Children
Measured: Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment
Change in PRS following treatment
Problem Rating Scale
Measured: Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start2 Aug 2017
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Trauma, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,200 participants (estimated)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Trauma Institute & Child Trauma Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ricky Greenwald, PsyD, Principal investigator, Trauma Institute & Child Trauma Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03271398
- Sponsor's protocol ID
- 2017-1001
- Status last verified
- Sep 2017
- First submitted
- 31 Aug 2017
- Last updated
- 7 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Greenwald R, Camden AA. A pragmatic randomized comparison of intensive EMDR and intensive PC for victims of crime. Psychol Trauma. 2024 Jan;16(1):134-142. doi: 10.1037/tra0001176. Epub 2022 Feb 10.
PubMed 35143219
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Therapy Archival Research
- ClinicalTrials.gov ID
- NCT03271398
- Acronym / sponsor ID
- 2017-1001
- Conditions
- Trauma, Psychological
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Trauma Institute & Child Trauma InstituteUniversity, hospital or other
- Study start
- 2 Aug 2017 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 5 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 12 Weeks
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Adult victims of sexual assault | – | Behavioral: EMDR, Behavioral: PC |
| Children who have been exposed to domestic abuse | – | Behavioral: EMDR, Behavioral: PC |
| Women with perinatal emotional complications | – | Behavioral: EMDR, Behavioral: PC |
| Teens with behavior problems and histories of abuse | – | Behavioral: EMDR, Behavioral: PC |
| Veterans with military-related trauma | – | Behavioral: EMDR, Behavioral: PC |
| Survivors of intimate partner violence | – | Behavioral: EMDR, Behavioral: PC |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All participants in the Trauma Institute \& Child Trauma Institute Victims of Crime program will be included.
Key inclusion criteria (2 listed)
- Victims of crimes, including assault, rape, robbery, intimate partner violence, child abuse, kidnapping, vehicular homicide, and suicide
- Witnesses and family members of victims
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMDREye movement desensitization and reprocessing (intensive format) | Behavioural | Adult victims of sexual assault, Children who have been exposed to domestic abuse, Survivors of intimate partner violence, Teens with behavior problems and histories of abuse, Veterans with military-related trauma, Women with perinatal emotional complications |
| PCProgressive counting (intensive format) | Behavioural | Adult victims of sexual assault, Children who have been exposed to domestic abuse, Survivors of intimate partner violence, Teens with behavior problems and histories of abuse, Veterans with military-related trauma, Women with perinatal emotional complications |
Primary outcome
Change in TSI-2 following treatment
Time frame: Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment
Trauma Symptom Inventory-2
Change in TSCC following treatment
Time frame: Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment
Trauma Symptom Checklist for Children
Change in PRS following treatment
Time frame: Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment
Problem Rating Scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2017.
- Derived from this study: PubMed 35143219Greenwald R, Camden AA. A pragmatic randomized comparison of intensive EMDR and intensive PC for victims of crime. Psychol Trauma. 2024 Jan;16(1):134-142. doi: 10.1037/tra0001176. Epub 2022 Feb 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricky Greenwald, PsyD principal investigator
Trauma Institute & Child Trauma Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma, Psychological, run by Trauma Institute & Child Trauma Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ricky Greenwald, PsyD (413-774-2340, cti@childtrauma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in TSI-2 following treatment (time frame: Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03271398, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2017; AzTrials last refreshed its copy on 27 Oct 2026.