Clinical Assessment of the Flash Version of Eye Movement Desensitization and Reprocessing in Memory Distress: A Double Blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- PTSD Checklist for DSM-5 (PCL-5) 1 - 44
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants, assessors and care providers (if participants are in treatment) are masked to trial allocation.
入排标准
- 年龄范围
- 20 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 >
排除标准
- •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
结局指标
主要结局
PTSD Checklist for DSM-5 (PCL-5) 1 - 44
时间窗: 1 month follow up
Self Report Questionnaire
State-Trait Anxiety Inventory - State 0 - 80.
时间窗: 1 month follow up
Self Report Questionnaire
次要结局
- Positive and Negative Affect Schedule 20 - 100(1 month followup)
- Patient Health Questionnaire 0 - 27(1 month follow up)
研究者
Paul Ritvo
Professor Kinesiology and Health Science
York University
