Clinical trial NCT05262127: Clinical Assessment of the Flash - Eye Movement Desensitization and Reprocessing
Official title: Clinical Assessment of the Flash Version of Eye Movement Desensitization and Reprocessing in Memory Distress: A Double Blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PTSD
Keywords: behavioural internet intervention, post-traumatic stress
Lead sponsor: York University
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel group, double-blind randomized controlled trial
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: PTSD Checklist for DSM-5 (PCL-5) 1 - 44
timeFrame: 1 month follow up
measure: State-Trait Anxiety Inventory - State 0 - 80.
timeFrame: 1 month follow up
Secondary outcomes:
measure: Patient Health Questionnaire 0 - 27
timeFrame: 1 month follow up
measure: Positive and Negative Affect Schedule 20 - 100
timeFrame: 1 month followup
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: York University
state: Ontario
city: Toronto
country: Canada
facility: York University - School of Kinesiology and Health Science
state: Ontario
Study officials:
References: