NCT05262127

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

January 4, 2023

Status Verified

February 1, 2022

Enrollment Period

1.5 years

First QC Date

December 29, 2021

Last Update Submit

January 3, 2023

Conditions

PTSD

Keywords

behavioural internet intervention, post-traumatic stress

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Patient Health Questionnaire 0 - 27

    1 month follow up

  • Positive and Negative Affect Schedule 20 - 100

    1 month followup

Study Arms (2)

Flash Version of EMDR

ACTIVE COMPARATOR

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 - alone

ACTIVE COMPARATOR

Use of standard EMDR techniques conveyed by video online

Behavioral: Flash Version of EMDR

Interventions

Flash Version of EMDRBEHAVIORAL

EMDR and the inclusion of a positive engaging focus generated autonomously by participant

EMDR - aloneFlash Version of EMDR

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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 \>

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

York University

Toronto, Ontario, M3J 1P3, Canada

RECRUITING

York University - School of Kinesiology and Health Science

Toronto, Ontario, M4E 3C1, Canada

RECRUITING

Related Publications (1)

  • Babaei N, Kerry C, Goode K, Dang K, Mirzadeh P, Pirbaglou M, Kirk MA, Ritvo P. Clinical Assessment of Eye Movement Desensitization and Reprocessing in Memory Distress: Protocol for a Double-Blinded Randomized Controlled Trial. JMIR Res Protoc. 2023 May 12;12:e38552. doi: 10.2196/38552.

    PMID: 37171869DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Central Study Contacts

Paul Ritvo, PhD

CONTACT

4165808021pritvo@yorku.ca

Nazanin Babaei, BSc

CONTACT

4167362100nazaninb@my.yorku.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Participants, assessors and care providers (if participants are in treatment) are masked to trial allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel group, double-blind randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Kinesiology and Health Science

Study Record Dates

First Submitted

December 29, 2021

First Posted

March 2, 2022

Study Start

September 1, 2021

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

January 4, 2023

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will share

Upon request, an anonymized data sheet (excel) will be sent

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Within 1 month of request
Access Criteria
Investigator at recognized academic or clinical institution

Locations

CA(2)