Flash Open Trial With Therapists In Training
Primary Purpose
Trauma, Psychological
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PC-based Flash
EMDR-based Flash
Sponsored by
About this trial
This is an interventional treatment trial for Trauma, Psychological
Eligibility Criteria
Inclusion Criteria:
- Therapist trained by Trauma Institute & Child Trauma Institute in EMDR or PC
Sites / Locations
- Trauma Institute & Child Trauma InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
PC-trained therapists
EMDR-trained therapists
Arm Description
Outcomes
Primary Outcome Measures
Change in SUDS following treatment
Subjective units of distress scale
Secondary Outcome Measures
Full Information
NCT ID
NCT03271437
First Posted
August 31, 2017
Last Updated
September 4, 2017
Sponsor
Trauma Institute & Child Trauma Institute
1. Study Identification
Unique Protocol Identification Number
NCT03271437
Brief Title
Flash Open Trial With Therapists In Training
Official Title
Flash Open Trial With Therapists In Training
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2017 (Anticipated)
Primary Completion Date
November 30, 2017 (Anticipated)
Study Completion Date
November 30, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trauma Institute & Child Trauma Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Psychological
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PC-trained therapists
Arm Type
Experimental
Arm Title
EMDR-trained therapists
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
PC-based Flash
Intervention Description
Progressive counting with Flash technique
Intervention Type
Behavioral
Intervention Name(s)
EMDR-based Flash
Intervention Description
Eye movement desensitization and reprocessing with Flash technique
Primary Outcome Measure Information:
Title
Change in SUDS following treatment
Description
Subjective units of distress scale
Time Frame
Pre-treatment, immediately post-treatment, one week post-treatment, and one month post-treatment
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Therapist trained by Trauma Institute & Child Trauma Institute in EMDR or PC
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ricky Greenwald, PsyD
Phone
413-774-2340
Email
cti@childtrauma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricky Greenwald, PsyD
Organizational Affiliation
Trauma Institute & Child Trauma Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Trauma Institute & Child Trauma Institute
City
Northampton
State/Province
Massachusetts
ZIP/Postal Code
01060
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ricky Greenwald, PsyD
Phone
413-774-2340
Email
cti@childtrauma.com
12. IPD Sharing Statement
Learn more about this trial
Flash Open Trial With Therapists In Training
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