Effects of an EMDR Intervention on Traumatic and Obsessive Symptoms

Not Applicable

Completed

• Conditions: Shame; Obsessive-Compulsive Disorder; Disgust; Guilt; Adult ALL; Post-traumatic Stress Disorder
• Interventions: Behavioral: EMDR

• Registration Number: NCT06110702
• Lead Sponsor: University of Pisa

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-10
• Primary Completion: 2022-04-30
• Study Completion: 2022-04-30
• Study First Submitted: 2023-10-23
• Study First Submitted QC: 2023-10-28
• Study First Posted: 2023-11-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-14
• Last Update Posted: 2024-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 287

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
8-week EMDR Intervention	EMDR	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.

Primary Outcome Measures

Name	Time	Method
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
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
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
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
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
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
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
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
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
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
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
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

Secondary Outcome Measures

Name	Time	Method
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
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
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
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
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
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

Trial Locations

Locations (1)

University of Pisa; 🇮🇹 Pisa, Italy