Effects of an EMDR Intervention on Traumatic and Obsessive Symptoms

NCT06110702 | Completed DMC

• 1 other identifier: MDL-01
• Study Type: interventional
• Target: 287
• Locations: 1 country
• Sites: 1

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.

Conditions

Adult ALL; Post-traumatic Stress Disorder; Obsessive-Compulsive Disorder; Disgust; Guilt; Shame

Keywords

PTSD; OCD; Disgust; Guilt; Shame; Body; EMDR

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (6)

• 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

• 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

• Depression Symptoms - Post-intervention

  DASS-21 is measured immediately after the 8-week EMDR intervention

Study Arms (2)

8-week EMDR Intervention

EXPERIMENTAL

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

Control condition - No intervention

NO INTERVENTION

The control group will follow routine daily activities

Interventions

EMDR BEHAVIORAL

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

8-week EMDR Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Concurrent enrollment in other intervention trials
• Participants that already experienced EMDR therapy in the past

Sponsors & Collaborators

• University of Pisa: lead

Study Sites (1)

University of Pisa

Pisa, 56126, Italy

Location

Related Publications (1)

• Miccoli M, Poli A. Randomized trial on the effects of an EMDR intervention on traumatic and obsessive symptoms during the COVID-19 quarantine: a psychometric study. Front Psychiatry. 2024 Jun 26;15:1369216. doi: 10.3389/fpsyt.2024.1369216. eCollection 2024.

  PMID: 38988736 DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Stress Disorders, Post-Traumatic; Obsessive-Compulsive Disorder

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Anxiety Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Andrea Poli, PsyD

  University of Pisa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: November 1, 2023
• Study Start: October 10, 2021
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

IT (1)