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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flash Version of EMDR | Active Comparator | Flash methods (e.g. positive engaging focus) are used in addition to the standard EMDR techniques conveyed by video viewed online |
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| EMDR - alone | Active Comparator | Use of standard EMDR techniques conveyed by video online |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flash Version of EMDR | Behavioral | EMDR and the inclusion of a positive engaging focus generated autonomously by participant |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paul Ritvo, PhD | Contact | 4165808021 | pritvo@yorku.ca | |
| Nazanin Babaei, BSc | Contact | 4167362100 | 22396 | nazaninb@my.yorku.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| York University | Recruiting | Toronto | Ontario | M3J 1P3 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37171869 | Derived | Babaei N, Kerry C, Goode K, Dang K, Mirzadeh P, Pirbaglou M, Kirk MA, Ritvo P. Clinical Assessment of Eye Movement Desensitization and Reprocessing in Memory Distress: Protocol for a Double-Blinded Randomized Controlled Trial. JMIR Res Protoc. 2023 May 12;12:e38552. doi: 10.2196/38552. |
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Upon request, an anonymized data sheet (excel) will be sent
Within 1 month of request
Investigator at recognized academic or clinical institution
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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Parallel group, double-blind randomized controlled trial
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Participants, assessors and care providers (if participants are in treatment) are masked to trial allocation.
| 1 month followup |
| York University - School of Kinesiology and Health Science | Recruiting | Toronto | Ontario | M4E 3C1 | Canada |
|