Effects of an EMDR Intervention on Traumatic and Obsessive Symptoms

NCT ID: NCT06110702

Last Updated: 2024-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

287 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-10

Study Completion Date

2022-04-30

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

EMDR

Intervention Type BEHAVIORAL

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

Control condition - No intervention

The control group will follow routine daily activities

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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EMDR

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pisa

OTHER

Sponsor Role lead

Responsible Party

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Andrea Poli

Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Poli, PsyD

Role: PRINCIPAL_INVESTIGATOR

University of Pisa

Locations

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University of Pisa

Pisa, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 38988736 (View on PubMed)

Other Identifiers

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MDL-01

Identifier Type: -

Identifier Source: org_study_id

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