Trauma, PsychologicalNCT03271437
Flash Open Trial With Therapists In Training
A study testing PC-based Flash and EMDR-based Flash in people with Trauma, Psychological, run by Trauma Institute & Child Trauma Institute at 1 site in United States.
Trial summary
This study will test the eye movement desensitization and reprocessing (EMDR) based Flash technique and a progressive counting (PC) based variant. EMDR-trained therapists will be trained in the standard Flash, and PC-trained therapists will be trained in PC Flash. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Trauma, Psychological
- What is being tested?
- PC-based Flash and EMDR-based Flash
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2017to 30 Nov 2017
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Therapist trained by Trauma Institute \& Child Trauma Institute in EMDR or PC
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 study will test the eye movement desensitization and reprocessing (EMDR) based Flash technique and a progressive counting (PC) based variant. EMDR-trained therapists will be trained in the standard Flash, and PC-trained therapists will be trained in PC Flash. In each group they will try it with a minor upsetting memory, and then with two more significant upsetting memories. Participants will use the subjective units of distress scale (SUDS) to rate distress pre- and post-treatment.
- Conditions
- Trauma, Psychological
- Being tested
- PC-based Flash, EMDR-based Flash
- Medical subject headings
- Psychological Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PC-based FlashBehavioural
Progressive counting with Flash technique
EMDR-based FlashBehavioural
Eye movement desensitization and reprocessing with Flash technique
| Study group | Role | What they receive |
|---|---|---|
| PC-trained therapists | Experimental | Not described Receives: Behavioral: PC-based Flash |
| EMDR-trained therapists | Experimental | Not described Receives: Behavioral: EMDR-based Flash |
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: Pre-treatment, immediately post-treatment, one week post-treatment, and one month 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 start15 Sep 2017 (estimated)
- Primary completion30 Nov 2017 (estimated)
- Study completion30 Nov 2017 (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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 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
- NCT03271437
- Sponsor's protocol ID
- 2017-1003
- 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
- Flash Open Trial With Therapists In Training
- ClinicalTrials.gov ID
- NCT03271437
- Acronym / sponsor ID
- 2017-1003
- Conditions
- Trauma, Psychological
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Trauma Institute & Child Trauma InstituteUniversity, hospital or other
- Study start
- 15 Sep 2017 (estimated)
- Primary completion
- 30 Nov 2017 (estimated)
- Study completion
- 30 Nov 2017 (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 study will test the eye movement desensitization and reprocessing (EMDR) based Flash technique and a progressive counting (PC) based variant. EMDR-trained therapists will be trained in the standard Flash, and PC-trained therapists will be trained in PC Flash. In each group they will try it with a minor upsetting memory, and then with two more significant upsetting memories. Participants will use the subjective units of distress scale (SUDS) to rate distress pre- and post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PC-trained therapists | Experimental | Behavioral: PC-based Flash |
| EMDR-trained therapists | Experimental | Behavioral: EMDR-based Flash |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Therapist trained by Trauma Institute \& Child Trauma Institute in EMDR or PC
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 |
|---|---|---|
| PC-based FlashProgressive counting with Flash technique | Behavioural | PC-trained therapists |
| EMDR-based FlashEye movement desensitization and reprocessing with Flash technique | Behavioural | EMDR-trained therapists |
Primary outcome
Change in SUDS following treatment
Time frame: Pre-treatment, immediately post-treatment, one week post-treatment, and one month post-treatment
Subjective units of distress 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 PC-based Flash and EMDR-based Flash in people with 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 1 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 SUDS following treatment (time frame: Pre-treatment, immediately post-treatment, one week post-treatment, and one month post-treatment). 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.