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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Post Traumatic Stress Disorder

Intervention / Treatment
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* Other: EMDR 2.0 group protocol
* Other: Mhgap stress module


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Control Group (3) vs EMDR 2.0 Group Intervention (3)
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trauma, EMDR, Post-traumatic stress disorder, Anxiety, Depression, Stress