Effect of Eye Movement Desensitization and Reprocessing Therapy 2.0 Online Group Protocol

May 7, 2023 updated by: Academy of Therapeutic Sciences, Turkey

Effect of Eye Movement Desensitization and Reprocessing Therapy 2.0 Online Group Protocol on Traumatic Experiences Based on Traffic Accident: A Randomized Controlled Trial

In this study, it will be investigated the efficacy of Eye Movement Desensitization and Reprocessing Therapy 2.0 Online Group Protocol on post-traumatic symptoms compared to control group. Therefore, the randomized control trial is based on Eye Movement Desensitization and Reprocessing Therapy 2.0 group as an intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Eye Movement Desensitization and Reprocessing Therapy is an evidence-based psychotherapy approach, and it is proven as efficient in primarily post-traumatic symptom disorder. EMDR 2.0 is a new approach which is used for the cases that are not answering the standard EMDR protocols. According to the recent studies, both EMDR and EMDR 2.0 show a greater decrease in emotionality and vividness in similar time based on session numbers (Matthijssen, 2021). Also, it is found that EMDR 2.0 requires lower set numbers (shorter sessions) compared to EMDR.

In this study, it will be investigated the efficacy of EMDR 2.0 Online Group Protocol on post-traumatic symptoms compared to control group. Therefore, the randomized control trial is based on EMDR 2.0 group as an intervention. Compared to previous EMDR 2.0 individual settings, this study is based on a group protocol made by our team. This group protocol has been tested in a pilot study on volunteer mental health professionals. The results of this pilot study showed that EMDR 2.0 group protocol was successful, and investigators decided to begin the randomized control trial research.

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Academy of Therapeutic Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being older than 18
  • Having a traffic accident between 6 months and 10 years
  • Having necessary knowledge on using relevant technological devices

Exclusion Criteria:

  • Having mental deterioration after the accident
  • Having a lower score of 7 on Adverse Childhood Experiences (ACEs)
  • Having pre-existing psychotic disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EMDR 2.0
EMDR 2.0 Online Group protocol will be administered.
Other: EMDR 2.0 group protocol
EMDR 2.0 group protocol
Active Comparator: Control
Mental Health Gap Action Programme (mhGAP) will be administered.
Other: Mhgap stress module
Mhgap stress module

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21)
Time Frame: 1-week and 1-month follow-up

Depression, stress and anxiety scores will significantly change. Scores for depression, anxiety and stress are calculated by summing the scores. The scores are between 0-3, and more scores mean worse results.

for the relevant items
1-week and 1-month follow-up
Impact of Events Scale Revised (IES-R)
Time Frame: 1-week and 1-month follow-up
Intrusion and hyperarousal scores will significantly change. The maximum mean score on each of the three subscales is '4', therefore the maximum 'total mean' IES- R score is 12. Lower scores are better.
1-week and 1-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Academy of Therapeutic Sciences, Turkey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2022

Primary Completion (Actual)

November 1, 2022

Study Completion (Actual)

January 20, 2023

Study Registration Dates

First Submitted

October 21, 2022

First Submitted That Met QC Criteria

October 25, 2022

First Posted (Actual)

October 27, 2022

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 7, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TBA2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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