Clinical Assessment of the Flash - Eye Movement Desensitization and Reprocessing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2023-03-01

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.

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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).

Conditions

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PTSD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel group, double-blind randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Participants, assessors and care providers (if participants are in treatment) are masked to trial allocation.

Study Groups

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Flash Version of EMDR

Flash methods (e.g. positive engaging focus) are used in addition to the standard EMDR techniques conveyed by video viewed online

Group Type ACTIVE_COMPARATOR

Flash Version of EMDR

Intervention Type BEHAVIORAL

EMDR and the inclusion of a positive engaging focus generated autonomously by participant

EMDR - alone

Use of standard EMDR techniques conveyed by video online

Group Type ACTIVE_COMPARATOR

Flash Version of EMDR

Intervention Type BEHAVIORAL

EMDR and the inclusion of a positive engaging focus generated autonomously by participant

Interventions

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Flash Version of EMDR

EMDR and the inclusion of a positive engaging focus generated autonomously by participant

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes