Effects of an EMDR Intervention on Traumatic and Obsessive Symptoms

Obsessive-Compulsive Disorder Clinical Trial

— MDL  

Official title:

Randomized Trial on the Effects of an EMDR Intervention on Traumatic and Obsessive Symptoms During the COVID19 Quarantine: a Psychometric Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06110702
• Other study ID #: MDL-01
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Adult ALL
• Guilt
• Obsessive-Compulsive Disorder
• Post-traumatic Stress Disorder
• Shame
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

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