Effects of an EMDR Intervention on Traumatic and Obsessive Symptoms (MDL)

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

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.

Study Overview

• Status: Completed
• Conditions: Obsessive-Compulsive Disorder; Post-traumatic Stress Disorder; Guilt; Adult ALL; Shame; Disgust
• Intervention / Treatment: Behavioral: EMDR

• Study Type: Interventional
• Enrollment (Actual): 287
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Pisa, Italy, 56126
    • University of Pisa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 8-week EMDR Intervention; Phase 1: The therapist and client develop a secure working relationship. The client's history is discussed and a treatment plan is developed. Phase 2: The therapist explains the EMDR therapy process. Phase 3: The target event is identified. Baseline measures are set using the Subjective Units of Disturbance (SUD) and the Validity of Cognition (VOC) scale. Phase 4: Desensitization, sounds, or taps are begun while focusing on the traumatic event until the client's SUD reduces to zero. Phase 5: The client associates and strengthens a positive belief with the target event until it feels true. Phase 6: The client is asked to hold in mind the target event and the positive belief while scanning the body. Phase 7: Reprocessing is complete when the client feels neutral about it (SUD=0, VOC=7), and the body is clear of disturbance. Phase 8: The client and therapist discuss processed memories to ensure that distress is low and that the positive cognition is strong.	Behavioral: EMDR; Eye movement Desensitization and Reprocessing (as described in the 8-phases protocol), administered both online or in presence.
No Intervention: Control condition - No intervention; The control group will follow routine daily activities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Pisa
• Investigators: Principal Investigator: Andrea Poli, PsyD, University of Pisa

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2021
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: October 28, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 14, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: PTSD; OCD; Body; Guilt; EMDR; Shame; Disgust
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Trauma and Stressor Related Disorders; Obsessive-Compulsive Disorder; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: MDL-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Raw data are available on request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No