Clinical Assessment of the Flash - Eye Movement Desensitization and Reprocessing

Not Applicable

• Conditions: PTSD

• Registration Number: NCT05262127
• Lead Sponsor: York University

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.

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 Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2021-12-29
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-26
• Study First Posted: 2022-03-02
• Last Update Submitted: 2023-01-03
• Last Update Posted: 2023-01-04
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Positive and Negative Affect Schedule 20 - 100	1 month followup	Self Report Questionnaire
Patient Health Questionnaire 0 - 27	1 month follow up	Self Report Questionnaire

Trial Locations

Locations (2)

York University; 🇨🇦 Toronto, Ontario, Canada

York University - School of Kinesiology and Health Science; 🇨🇦 Toronto, Ontario, Canada