Clinical Assessment of the Flash - Eye Movement Desensitization and Reprocessing

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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PTSD

Intervention / Treatment
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* Behavioral: Flash Version of EMDR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel group, double-blind randomized controlled trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Flash Version of EMDR<br>Flash methods (e.g. positive engaging focus) are used in addition to the standard EMDR techniques conveyed by video viewed online | Behavioral: Flash Version of EMDR<br>* EMDR and the inclusion of a positive engaging focus generated autonomously by participant<br>|
| Active Comparator: EMDR - alone<br>Use of standard EMDR techniques conveyed by video online | Behavioral: Flash Version of EMDR<br>* EMDR and the inclusion of a positive engaging focus generated autonomously by participant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD Checklist for DSM-5 (PCL-5) 1 - 44 | Self Report Questionnaire | 1 month follow up | 
| State-Trait Anxiety Inventory - State 0 - 80. | Self Report Questionnaire | 1 month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire 0 - 27 | Self Report Questionnaire | 1 month follow up | 
| Positive and Negative Affect Schedule 20 - 100 | Self Report Questionnaire | 1 month followup | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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behavioural internet intervention, post-traumatic stress