Trauma, PsychologicalNCT03271411
Extension of EMDR vs. PC For Motor Vehicle Accident Trauma
A study testing EMDR-based Flash technique and PC-based Flash technique in people with Trauma, Psychological and Motor Vehicle Accident, run by Trauma Institute & Child Trauma Institute at 1 site in United States.
Trial summary
This is an extension of 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, Psychological, Motor Vehicle Accident
- What is being tested?
- EMDR-based Flash technique and PC-based Flash technique
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2017to 31 Dec 2018
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult reporting distress related to motor vehicle accident-related trauma
- English-speaking
Who cannot join
- 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
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 extension of 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. The purpose of this extension is to add Phil Manfield's recently developed Flash technique as a precursor to both EMDR and PC, to see a) if that has any impact on participant retention, treatment effectiveness, or treatment efficiency; and b) if such impact is equivalent with EMDR and PC.
- Conditions
- Trauma, Psychological, Motor Vehicle Accident
- Being tested
- EMDR-based Flash technique, PC-based Flash technique
- Medical subject headings
- Psychological Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMDR-based Flash techniqueBehavioural
Initial EMDR session (with Flash technique) of up to three hours; about one week later, follow-up session of up to one hour
PC-based Flash techniqueBehavioural
Initial PC session (with Flash technique) of up to three hours; about one week later, follow-up session of up to one hour
| Study group | Role | What they receive |
|---|---|---|
| Eye movement desensitization and reprocessing (EMDR) arm | Experimental | Not described Receives: Behavioral: EMDR-based Flash technique |
| Progressive counting (PC) arm | Experimental | Not described Receives: Behavioral: PC-based Flash technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SUDS following treatment
Subjective Units of Distress Scale
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
Change in PDS following treatment
PTSD Diagnostic 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 start30 Aug 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
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
- NCT03271411
- Sponsor's protocol ID
- 2017-1002
- 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
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
- Extension of EMDR vs. PC For Motor Vehicle Accident Trauma
- ClinicalTrials.gov ID
- NCT03271411
- Acronym / sponsor ID
- 2017-1002
- Conditions
- Trauma, Psychological, Motor Vehicle Accident
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Trauma Institute & Child Trauma InstituteUniversity, hospital or other
- Study start
- 30 Aug 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (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 extension of 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. The purpose of this extension is to add Phil Manfield's recently developed Flash technique as a precursor to both EMDR and PC, to see a) if that has any impact on participant retention, treatment effectiveness, or treatment efficiency; and b) if such impact is equivalent with EMDR and PC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eye movement desensitization and reprocessing (EMDR) arm | Experimental | Behavioral: EMDR-based Flash technique |
| Progressive counting (PC) arm | Experimental | Behavioral: PC-based Flash technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult reporting distress related to motor vehicle accident-related trauma
- English-speaking
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| EMDR-based Flash techniqueInitial EMDR session (with Flash technique) of up to three hours; about one week later, follow-up session of up to one hour | Behavioural | Eye movement desensitization and reprocessing (EMDR) arm |
| PC-based Flash techniqueInitial PC session (with Flash technique) of up to three hours; about one week later, follow-up session of up to one hour | Behavioural | Progressive counting (PC) arm |
Primary outcome
Change in SUDS following treatment
Time frame: Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment
Subjective Units of Distress Scale
Change in PRS following treatment
Time frame: Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment
Problem Rating Scale
Change in PDS following treatment
Time frame: Administered pre-treatment, two weeks post-treatment, and 12 weeks post-treatment
PTSD Diagnostic 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.
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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?
A study testing EMDR-based Flash technique and PC-based Flash technique in people with Trauma, Psychological and Motor Vehicle Accident, 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 4 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 SUDS 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?
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.