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Completed

NCT Number: NCT06110702

Effects of an EMDR Intervention on Traumatic and Obsessive Symptoms

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.

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Key information

Conditions

Adult ALL Anxiety Disorders Disgust Guilt Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Mental Disorders Neoplasms Neoplasms by Histologic Type Obsessive-Compulsive Disorder Post-traumatic Stress Disorder Precursor Cell Lymphoblastic Leukemia-Lymphoma Shame Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pisa

Pisa, 56126, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

EMDR

Behavioral

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

Primary outcomes

  1. Post-Traumatic Stress Symptoms - Pre-intervention

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Anxiety Symptoms - Pre-intervention

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Pisa

Other

Registry information

Official study title

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

Acronym: MDL

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 1, 2023
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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