Clinical Assessment of the Flash - Eye Movement Desensitization and Reprocessing

PTSD Clinical Trial

— Flash-EMDR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05262127
• Other study ID #: 2021-141
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: March 1, 2023

Study information

• Verified date: February 2022
• Source: York University
• Contact: Paul Ritvo, PhD
• Phone: 4165808021
• Email: pritvo[@]yorku.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• PTSD

Intervention

Behavioral:
• Flash Version of EMDR
EMDR and the inclusion of a positive engaging focus generated autonomously by participant

Locations

Country	Name	City	State
Canada	York University	Toronto	Ontario
Canada	York University - School of Kinesiology and Health Science	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
York University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD Checklist for DSM-5 (PCL-5) 1 - 44	Self Report Questionnaire	1 month follow up
Primary	State-Trait Anxiety Inventory - State 0 - 80.	Self Report Questionnaire	1 month follow up
Secondary	Patient Health Questionnaire 0 - 27	Self Report Questionnaire	1 month follow up
Secondary	Positive and Negative Affect Schedule 20 - 100	Self Report Questionnaire	1 month followup