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临床试验/NCT05262127
NCT05262127Unknown不适用

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

York University4 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年9月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Paul Ritvo

Professor Kinesiology and Health Science

York University

研究点 (4)

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