PTSD
Conditions
Keywords
behavioural internet intervention, post-traumatic stress
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).
Interventions
EMDR and the inclusion of a positive engaging focus generated autonomously by participant
Sponsors
Study design
Masking description
Participants, assessors and care providers (if participants are in treatment) are masked to trial allocation.
Intervention model description
Parallel group, double-blind randomized controlled trial
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Checklist for DSM-5 (PCL-5) 1 - 44 | 1 month follow up | Self Report Questionnaire |
| State-Trait Anxiety Inventory - State 0 - 80. | 1 month follow up | Self Report Questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire 0 - 27 | 1 month follow up | Self Report Questionnaire |
| Positive and Negative Affect Schedule 20 - 100 | 1 month followup | Self Report Questionnaire |
Countries
Canada