MDL: Effects of an EMDR Intervention on Traumatic and Obsessive Symptoms

• Sponsor: University of Pisa (Other)
• Overall Status: Completed
• CT.gov ID: NCT06110702
• Collaborator: (none)
• Enrollment: 287
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.6
• Patients Per Site Per Month: 43.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Adult ALL; Post-traumatic Stress Disorder; Obsessive-Compulsive Disorder; Disgust; Guilt; Shame	Behavioral: EMDR	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 287 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Randomized Trial on the Effects of an EMDR Intervention on Traumatic and Obsessive Symptoms During the COVID19 Quarantine: a Psychometric Study
• Actual Study Start Date: Oct 10, 2021
• Actual Primary Completion Date: Apr 30, 2022
• Actual Study Completion Date: Apr 30, 2022

Arms and Interventions

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 decribed 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

Outcome Measures

Primary Outcome Measures

1. Post-Traumatic Stress Symptoms - Pre-intervention [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

2. Obsessive-Compulsive Symptoms - Pre-intervention [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

3. Body Perception - Pre-intervention [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

4. Guilt and Shame - Pre-intervention [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

5. Disgust - Pre-intervention [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

6. Mental Contamination - Pre-intervention [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

7. Post-Traumatic Stress Symptoms - Post-intervention [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

8. Obsessive-Compulsive Symptoms - Post-intervention [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

9. Body Perception - Post-intervention [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

10. Guilt and Shame - Post-intervention [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

11. Disgust - Post-intervention [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

12. Mental Contamination - Post-intervention [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

Secondary Outcome Measures

1. Anxiety Symptoms - Pre-intervention [DASS-21 is measured immediately before the 8-week EMDR 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

2. Depression Symptoms - Pre-intervention [DASS-21 is measured immediately before the 8-week EMDR 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

3. General distress symptoms - Pre-intervention [DASS-21 is measured immediately before the 8-week EMDR 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

4. Anxiety Symptoms - Post-intervention [DASS-21 is measured immediately after the 8-week EMDR 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

5. Depression Symptoms - Post-intervention [DASS-21 is measured immediately after the 8-week EMDR 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

6. General distress symptoms - Post-intervention [DASS-21 is measured immediately after the 8-week EMDR 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pisa	Pisa		Italy	56126

Sponsors and Collaborators

• University of Pisa

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Andrea Poli, Research Fellow, University of Pisa
• ClinicalTrials.gov Identifier: NCT06110702
• Other Study ID Numbers: MDL-01
• First Posted: Nov 1, 2023
• Last Update Posted: Nov 1, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Andrea Poli, Research Fellow, University of Pisa: PTSD; OCD; Disgust; Guilt; Shame; Body; EMDR
• Additional relevant MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Obsessive-Compulsive Disorder

Study Results

No Results Posted as of Nov 1, 2023