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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06110702
Other study ID # MDL-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 10, 2021
Est. completion date April 30, 2022

Study information

Verified date April 2024
Source University of Pisa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 287
Est. completion date April 30, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. Participants aged 18 to 75 years 2. Participants experienced a full COVID19 pandemic-related quarantine during red zones of the second and third lockdowns in Italy 3. Participants have reasonable comprehension of spoken and written Italian language 4. Participants have an adequate understanding of Italian Exclusion Criteria: 1. Concurrent enrollment in other intervention trials 2. Participants that already experienced EMDR therapy in the past

Study Design


Intervention

Behavioral:
EMDR
Eye movement Desensitization and Reprocessing (as described in the 8-phases protocol), administered both online or in presence.

Locations

Country Name City State
Italy University of Pisa Pisa

Sponsors (1)

Lead Sponsor Collaborator
University of Pisa

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Post-Traumatic Stress Symptoms - Pre-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 IES-R is measured immediately before the 8-week EMDR intervention
Primary Obsessive-Compulsive Symptoms - Pre-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 DOCS is measured immediately before the 8-week EMDR intervention
Primary Body Perception - Pre-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 BPQ-22 is measured immediately before the 8-week EMDR intervention
Primary Guilt and Shame - Pre-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 GASP is measured immediately before the 8-week EMDR intervention
Primary Disgust - Pre-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 TDDS is measured immediately before the 8-week EMDR intervention
Primary Mental Contamination - Pre-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 VOCI-MC is measured immediately before the 8-week EMDR intervention
Primary Post-Traumatic Stress Symptoms - Post-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 IES-R is measured immediately after the 8-week EMDR intervention
Primary Obsessive-Compulsive Symptoms - Post-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 DOCS is measured immediately after the 8-week EMDR intervention
Primary Body Perception - Post-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 BPQ-22 is measured immediately after the 8-week EMDR intervention
Primary Guilt and Shame - Post-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 GASP is measured immediately after the 8-week EMDR intervention
Primary Disgust - Post-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 TDDS is measured immediately after the 8-week EMDR intervention
Primary Mental Contamination - Post-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 VOCI-MC is measured immediately after the 8-week EMDR intervention
Secondary Anxiety Symptoms - Pre-intervention Anxiety symptoms are measured using the Depression Anxiety Stress Scales (DASS-21).The scale ranges from a minimum value of 0 to a maximum value of 63. Lower Likert score means a better outcome DASS-21 is measured immediately before the 8-week EMDR intervention
Secondary Depression Symptoms - Pre-intervention Depression symptoms are measured using the Depression Anxiety Stress Scales (DASS-21). The scale ranges from a minimum value of 0 to a maximum value of 63. Lower Likert score means a better outcome DASS-21 is measured immediately before the 8-week EMDR intervention
Secondary General distress symptoms - Pre-intervention General distress symptoms are measured using the Depression Anxiety Stress Scales (DASS-21). The scale ranges from a minimum value of 0 to a maximum value of 63. Lower Likert score means a better outcome DASS-21 is measured immediately before the 8-week EMDR intervention
Secondary Anxiety Symptoms - Post-intervention Anxiety symptoms are measured using the Depression Anxiety Stress Scales (DASS-21). The scale ranges from a minimum value of 0 to a maximum value of 63. Lower Likert score means a better outcome DASS-21 is measured immediately after the 8-week EMDR intervention
Secondary Depression Symptoms - Post-intervention Depression symptoms are measured using the Depression Anxiety Stress Scales (DASS-21). The scale ranges from a minimum value of 0 to a maximum value of 63. Lower Likert score means a better outcome DASS-21 is measured immediately after the 8-week EMDR intervention
Secondary General distress symptoms - Post-intervention General distress symptoms are measured using the Depression Anxiety Stress Scales (DASS-21). The scale ranges from a minimum value of 0 to a maximum value of 63. Lower Likert score means a better outcome DASS-21 is measured immediately after the 8-week EMDR intervention
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