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

Y

York University

Status

Unknown

Conditions

PTSD

Treatments

Behavioral: Flash Version of EMDR

Study type

Interventional

Funder types

Other

Identifiers

NCT05262127
2021-141

Details and patient eligibility

About

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.

Full 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).

Enrollment

90 estimated patients

Sex

All

Ages

20 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

90 participants in 2 patient groups

Flash Version of EMDR
Active Comparator group
Description:
Flash methods (e.g. positive engaging focus) are used in addition to the standard EMDR techniques conveyed by video viewed online
Treatment:
Behavioral: Flash Version of EMDR
EMDR - alone
Active Comparator group
Description:
Use of standard EMDR techniques conveyed by video online
Treatment:
Behavioral: Flash Version of EMDR

Trial contacts and locations

2

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Central trial contact

Nazanin Babaei, BSc; Paul Ritvo, PhD

Data sourced from clinicaltrials.gov

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