Randomized Trial on the Effects of an EMDR Intervention on Traumatic and Obsessive Symptoms During the COVID19 Quarantine: a Psychometric Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 287
- 试验地点
- 2
- 主要终点
- Obsessive-Compulsive Symptoms - Pre-intervention
研究概览
简要总结
The Eye Movement Desensitization and Reprocessing Protocol (EMDR) was first developed by Francine Shapiro in 1987 and can be adapted for online and in presence administration. The aim of this study is to assess if a EMDR program (administered both online and in presence, depending on different conditions of patients) may help people recruited from general population suffering from COVID19 second (November 2021 to February 2022) and third (March 2022 to May 2022) quarantine in improving post-traumatic stress (PTSD) and obsessive-compulsive-related (OCD) symptoms, as well as disgust, guilt, shame and their subjective unit of distress (SUD) and validity of cognition (VoC) levels.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants aged 18 to 75 years
- •Participants experienced a full COVID19 pandemic-related quarantine during red zones of the second and third lockdowns in Italy
- •Participants have reasonable comprehension of spoken and written Italian language
- •Participants have an adequate understanding of Italian
排除标准
- •Concurrent enrollment in other intervention trials
- •Participants that already experienced EMDR therapy in the past
结局指标
主要结局
Obsessive-Compulsive Symptoms - Pre-intervention
时间窗: DOCS is measured immediately before the 8-week EMDR intervention
Obsessive-Compulsive symptoms are measured using the Dimensional Obsessive-Compulsive Scale (DOCS). The scale ranges from a minimum value of 0 to a maximum value of 80. Lower Likert score means a better outcome
Body Perception - Pre-intervention
时间窗: BPQ-22 is measured immediately before the 8-week EMDR intervention
Body Perception is measured using the Body Perception Questionnaire-22 (BPQ-22). The scale ranges from a minimum value of 22 to a maximum value of 66. Lower Likert score means a better outcome
Guilt and Shame - Pre-intervention
时间窗: GASP is measured immediately before the 8-week EMDR intervention
Guilt and Shame are measured using the Guilt and Shame Proneness Scale (GASP). The scale ranges from a minimum value of 16 to a maximum value of 112. Lower Likert score means a better outcome
Guilt and Shame - Post-intervention
时间窗: GASP is measured immediately after the 8-week EMDR intervention
Guilt and Shame are measured using the Guilt and Shame Proneness Scale (GASP). The scale ranges from a minimum value of 16 to a maximum value of 112. Lower Likert score means a better outcome
Disgust - Pre-intervention
时间窗: TDDS is measured immediately before the 8-week EMDR intervention
Disgust is measured using the Three Domain of Disgust Scale (TDDS). The scale ranges from a minimum value of 0 to a maximum value of 126. Lower Likert score means a better outcome
Post-Traumatic Stress Symptoms - Post-intervention
时间窗: IES-R is measured immediately after the 8-week EMDR intervention
Post-Traumatic symptoms are measured using the Impact of Event Scale-Revised (IES-R). The scale ranges from a minimum value of 0 to a maximum value of 88. Lower Likert score means a better outcome
Mental Contamination - Post-intervention
时间窗: VOCI-MC is measured immediately after the 8-week EMDR intervention
Mental Contamination is measured using the Vancouver Obsessional Compulsive Inventory-Mental Contamination scale (VOCI-MC). The scale ranges from a minimum value of 0 to a maximum value of 80. Lower Likert score means a better outcome
Post-Traumatic Stress Symptoms - Pre-intervention
时间窗: IES-R is measured immediately before the 8-week EMDR intervention
Post-Traumatic symptoms are measured using the Impact of Event Scale-Revised (IES-R). The scale ranges from a minimum value of 0 to a maximum value of 88. Lower Likert score means a better outcome
Obsessive-Compulsive Symptoms - Post-intervention
时间窗: DOCS is measured immediately after the 8-week EMDR intervention
Obsessive-Compulsive symptoms are measured using the Dimensional Obsessive-Compulsive Scale (DOCS). The scale ranges from a minimum value of 0 to a maximum value of 80. Lower Likert score means a better outcome
Disgust - Post-intervention
时间窗: TDDS is measured immediately after the 8-week EMDR intervention
Disgust is measured using the Three Domain of Disgust Scale (TDDS). The scale ranges from a minimum value of 0 to a maximum value of 126. Lower Likert score means a better outcome
Mental Contamination - Pre-intervention
时间窗: VOCI-MC is measured immediately before the 8-week EMDR intervention
Mental Contamination is measured using the Vancouver Obsessional Compulsive Inventory-Mental Contamination scale (VOCI-MC). The scale ranges from a minimum value of 0 to a maximum value of 80. Lower Likert score means a better outcome
Body Perception - Post-intervention
时间窗: BPQ-22 is measured immediately after the 8-week EMDR intervention
Body Perception is measured using the Body Perception Questionnaire-22 (BPQ-22). The scale ranges from a minimum value of 22 to a maximum value of 66. Lower Likert score means a better outcome
次要结局
- Anxiety Symptoms - Pre-intervention(DASS-21 is measured immediately before the 8-week EMDR intervention)
- Depression Symptoms - Pre-intervention(DASS-21 is measured immediately before the 8-week EMDR intervention)
- Depression Symptoms - Post-intervention(DASS-21 is measured immediately after the 8-week EMDR intervention)
- General distress symptoms - Post-intervention(DASS-21 is measured immediately after the 8-week EMDR intervention)
- General distress symptoms - Pre-intervention(DASS-21 is measured immediately before the 8-week EMDR intervention)
- Anxiety Symptoms - Post-intervention(DASS-21 is measured immediately after the 8-week EMDR intervention)
研究者
Andrea Poli
Research Fellow
University of Pisa