Clinical trial NCT06110702: Effects of an EMDR Intervention on Traumatic and Obsessive Symptoms
Official title: Randomized Trial on the Effects of an EMDR Intervention on Traumatic and Obsessive Symptoms During the COVID19 Quarantine: a Psychometric Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adult ALL
Post-traumatic Stress Disorder
Obsessive-Compulsive Disorder
Disgust
Guilt
Shame
Keywords: PTSD
OCD
Disgust
Guilt
Shame
Body
EMDR
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 287
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Post-Traumatic Stress Symptoms - Pre-intervention
timeFrame: IES-R is measured immediately before the 8-week EMDR intervention
measure: Obsessive-Compulsive Symptoms - Pre-intervention
timeFrame: DOCS is measured immediately before the 8-week EMDR intervention
measure: Body Perception - Pre-intervention
timeFrame: BPQ-22 is measured immediately before the 8-week EMDR intervention
measure: Guilt and Shame - Pre-intervention
timeFrame: GASP is measured immediately before the 8-week EMDR intervention
measure: Disgust - Pre-intervention
timeFrame: TDDS is measured immediately before the 8-week EMDR intervention
measure: Mental Contamination - Pre-intervention
timeFrame: VOCI-MC is measured immediately before the 8-week EMDR intervention
measure: Post-Traumatic Stress Symptoms - Post-intervention
timeFrame: IES-R is measured immediately after the 8-week EMDR intervention
measure: Obsessive-Compulsive Symptoms - Post-intervention
timeFrame: DOCS is measured immediately after the 8-week EMDR intervention
measure: Body Perception - Post-intervention
timeFrame: BPQ-22 is measured immediately after the 8-week EMDR intervention
measure: Guilt and Shame - Post-intervention
timeFrame: GASP is measured immediately after the 8-week EMDR intervention
measure: Disgust - Post-intervention
timeFrame: TDDS is measured immediately after the 8-week EMDR intervention
measure: Mental Contamination - Post-intervention
timeFrame: VOCI-MC is measured immediately after the 8-week EMDR intervention
Secondary outcomes:
measure: Anxiety Symptoms - Pre-intervention
timeFrame: DASS-21 is measured immediately before the 8-week EMDR intervention
measure: Depression Symptoms - Pre-intervention
timeFrame: DASS-21 is measured immediately before the 8-week EMDR intervention
measure: General distress symptoms - Pre-intervention
timeFrame: DASS-21 is measured immediately before the 8-week EMDR intervention
measure: Anxiety Symptoms - Post-intervention
timeFrame: DASS-21 is measured immediately after the 8-week EMDR intervention
measure: Depression Symptoms - Post-intervention
timeFrame: DASS-21 is measured immediately after the 8-week EMDR intervention
measure: General distress symptoms - Post-intervention
timeFrame: DASS-21 is measured immediately after the 8-week EMDR intervention
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: University of Pisa
Study officials:
affiliation: University of Pisa
name: Andrea Poli, PsyD
role: PRINCIPAL_INVESTIGATOR
References: