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Clinical Assessment of the Flash - Eye Movement Desensitization and Reprocessing

Not Applicable
Conditions
PTSD
Interventions
Behavioral: Flash Version of EMDR
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).

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
Arm && Interventions
GroupInterventionDescription
EMDR - aloneFlash Version of EMDRUse of standard EMDR techniques conveyed by video online
Flash Version of EMDRFlash Version of EMDRFlash methods (e.g. positive engaging focus) are used in addition to the standard EMDR techniques conveyed by video viewed online
Primary Outcome Measures
NameTimeMethod
PTSD Checklist for DSM-5 (PCL-5) 1 - 441 month follow up

Self Report Questionnaire

State-Trait Anxiety Inventory - State 0 - 80.1 month follow up

Self Report Questionnaire

Secondary Outcome Measures
NameTimeMethod
Positive and Negative Affect Schedule 20 - 1001 month followup

Self Report Questionnaire

Patient Health Questionnaire 0 - 271 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

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