Clinical Assessment of the Flash - Eye Movement Desensitization and Reprocessing (Flash-EMDR)

Clinical Assessment of the Flash Version of Eye Movement Desensitization and Reprocessing in Memory Distress: A Double Blinded Randomized Controlled Trial

To assess the Flash version of EMDR in reductions of the disturbance of upsetting memories at post-intervention, and 1-month follow up within a double-blinded, online 2-arm randomized controlled trial (RCT) with self-report outcomes. We will assess 45 per group, adequate for the detection of a medium effect size.

This double-blinded, RCT will assess the comparative efficacy of these two online interventions designed to reduce memory disturbance.

Study Overview

• Status: Recruiting
• Conditions: PTSD
• Intervention / Treatment: Behavioral: Flash Version of EMDR

Detailed Description

This double-blinded, RCT compares the efficacy of 2 online interventions (Flash Version - EMDR; EMDR alone) designed to reduce memory disturbance.Inclusion Criteria: (1) approved for engagement assessment by the CloudResearch platform; (2) 25-60 years; 3) US-Canada residence; (4) a recalled disturbing memory of an event that has not repeated and was moderately upsetting, or greater when event occurred; (5) memory remains moderately upsetting or greater on recall. The disturbance of upsetting memories at post-intervention, and 1-month follow up will be assessed with self-report outcomes. We will assess 45 / group, adequate for the detection of a medium effect size. linked to an earlier memory (that is equally or more disturbing). Exclusion Criteria: Diagnosis of: (1) bipolar disorder; (2) borderline personality disorder; (3) obsessive compulsive disorder; (4) schizophrenia; (5) substance abuse/addiction in the past 3 months; (6) any suicidal ideation; (7) suicide attempt in the past 6 months. Interventions: Experimental participants observe video instructions of full FT, while controls receive an online intervention that follows traditional EMDR. Measures: Primary outcome: State Anxiety subscale of the State Trait Anxiety Inventory (STAI) at baseline, post-intervention, and after 1-month follow up; Post Traumatic Stress Disorder symptoms (PTSD) measured by PCL-5 (1 month follow up).

Secondary outcomes: the Subjective Units of Disturbance (SUDs) assessing change in immediately reported disturbance of recalled memories (baseline and post-intervention); depression measured by Patient Health Questionnaire (PHQ9) and Positive-Negative Affect measured by the Positive and Negative Affect Scale (PANAS).

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nazanin Babaei, BSc; Phone Number: 22396 4167362100; Email: nazaninb@my.yorku.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M3J 1P3
      • Recruiting
      • York University
    • Toronto, Ontario, Canada, M4E 3C1
      • Recruiting
      • York University - School of Kinesiology and Health Science
      • Contact: Nazanin Babaei, BSc; Phone Number: 4167362100; Email: nazaninb@my.yorku.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Moderately upsetting or > memory of an event that occurred > 2 years ago and has since not repeated
• Moderately upsetting or > memory remains moderately upsetting when recalled
• Memory is not tied to an earlier memory that is equally disturbing or >

Exclusion Criteria:

• Bipolar Disorder
• Borderline Personality Disorder
• Obsessive-Compulsive Disorder
• Schizophrenia
• Substance Abuse/Addiction in past 3 months
• Suicidal ideation or attempted suicide in the past 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Flash Version of EMDR; Flash methods (e.g. positive engaging focus) are used in addition to the standard EMDR techniques conveyed by video viewed online	Behavioral: Flash Version of EMDR; EMDR and the inclusion of a positive engaging focus generated autonomously by participant
Active Comparator: EMDR - alone; Use of standard EMDR techniques conveyed by video online	Behavioral: Flash Version of EMDR; EMDR and the inclusion of a positive engaging focus generated autonomously by participant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTSD Checklist for DSM-5 (PCL-5) 1 - 44	Self Report Questionnaire	1 month follow up
State-Trait Anxiety Inventory - State 0 - 80.	Self Report Questionnaire	1 month follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire 0 - 27	Self Report Questionnaire	1 month follow up
Positive and Negative Affect Schedule 20 - 100	Self Report Questionnaire	1 month followup

Collaborators and Investigators

• Sponsor: York University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: December 29, 2021
• First Submitted That Met QC Criteria: February 26, 2022
• First Posted (Actual): March 2, 2022

Study Record Updates

• Last Update Posted (Estimate): January 4, 2023
• Last Update Submitted That Met QC Criteria: January 3, 2023
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: behavioural internet intervention, post-traumatic stress
• Other Study ID Numbers: 2021-141

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Upon request, an anonymized data sheet (excel) will be sent
• IPD Sharing Time Frame: Within 1 month of request
• IPD Sharing Access Criteria: Investigator at recognized academic or clinical institution
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No