Flash Open Trial With Therapists In Training | NCT03271437

Studies
Flash Open Trial With Therapists In Training

NCT03271437

Sponsor

Trauma Institute & Child Trauma Institute

Status

Unknown status

Last Update Posted

Sep 7, 2017Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Trauma, Psychological

Interventions

PC-based Flash
EMDR-based Flash

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2017Estimated

Primary Completion Date

Nov 30, 2017Estimated

Completion Date

Nov 30, 2017Estimated

First Submitted Date

Aug 31, 2017

First Submission Date that Met QC Criteria

Aug 31, 2017

First Posted Date

Sep 5, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 4, 2017

Last Update Posted Date

Sep 7, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PC-trained therapists	Experimental		Behavioral: PC-based Flash
EMDR-trained therapists	Experimental		Behavioral: EMDR-based Flash

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PC-based Flash	Behavioral	Progressive counting with Flash technique	PC-trained therapists

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in SUDS following treatment	Subjective units of distress scale	Pre-treatment, immediately post-treatment, one week post-treatment, and one month post-treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Therapist trained by Trauma Institute & Child Trauma Institute in EMDR or PC

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ricky Greenwald, PsyD	Contact	413-774-2340		cti@childtrauma.com

Overall Officials

Name	Affiliation	Role
Ricky Greenwald, PsyD	Trauma Institute & Child Trauma Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Trauma Institute & Child Trauma Institute	Recruiting	Northampton	Massachusetts	01060	United States

Condition Browse Module

MeSH Terms

ID	Term
D000067073	Psychological Trauma

Ancestor Terms

ID	Term
D040921	Stress Disorders, Traumatic
D000068099	Trauma and Stressor Related Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided