NCT05596903

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 14, 2022

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 27, 2022

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2023

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

18 days

First QC Date

October 21, 2022

Last Update Submit

May 7, 2023

Conditions

Keywords

EMDRPost-traumatic stress disorderAnxietyDepressionStressTrauma

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

EMDR 2.0

EXPERIMENTAL

EMDR 2.0 Online Group protocol will be administered.

Other: EMDR 2.0 group protocol

Control

ACTIVE COMPARATOR

Mental Health Gap Action Programme (mhGAP) will be administered.

Other: Mhgap stress module

Interventions

EMDR 2.0 group protocol

EMDR 2.0

Mhgap stress module

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academy of Therapeutic Sciences

Istanbul, Turkey (Türkiye)

Location

Related Publications (11)

  • Baddeley A. Working memory: theories, models, and controversies. Annu Rev Psychol. 2012;63:1-29. doi: 10.1146/annurev-psych-120710-100422. Epub 2011 Sep 27.

  • de Jongh A, Ernst R, Marques L, Hornsveld H. The impact of eye movements and tones on disturbing memories involving PTSD and other mental disorders. J Behav Ther Exp Psychiatry. 2013 Dec;44(4):477-83. doi: 10.1016/j.jbtep.2013.07.002. Epub 2013 Jul 13.

  • Littel, M., Remijn, M., Tinga, A. M., Engelhard, I. M., & van den Hout, M. A. (2017). Stress Enhances the Memory-Degrading Effects of Eye Movements on Emotionally Neutral Memories. Clinical Psychological Science, 5(2), 316-324. https://doi.org/10.1177/2167702616687292

    RESULT
  • Littel M, van Schie K. No evidence for the inverted U-Curve: More demanding dual tasks cause stronger aversive memory degradation. J Behav Ther Exp Psychiatry. 2019 Dec;65:101484. doi: 10.1016/j.jbtep.2019.101484. Epub 2019 May 13.

  • Matthijssen SJMA, Verhoeven LCM, van den Hout MA, Heitland I. Auditory and Visual Memories in PTSD Patients Targeted with Eye Movements and Counting: The Effect of Modality-Specific Loading of Working Memory. Front Psychol. 2017 Nov 3;8:1937. doi: 10.3389/fpsyg.2017.01937. eCollection 2017.

  • Matthijssen SJMA, van Beerschoten LM, de Jongh A, Klugkist IG, van den Hout MA. Effects of "Visual Schema Displacement Therapy" (VSDT), an abbreviated EMDR protocol and a control condition on emotionality and vividness of aversive memories: Two critical analogue studies. J Behav Ther Exp Psychiatry. 2019 Jun;63:48-56. doi: 10.1016/j.jbtep.2018.11.006. Epub 2018 Nov 27.

  • Matthijssen SJMA, van Schie K, van den Hout MA. The Effect of modality specific interference on working memory in recalling aversive auditory and visual memories. Cogn Emot. 2019 Sep;33(6):1169-1180. doi: 10.1080/02699931.2018.1547271. Epub 2018 Nov 22.

  • Matthijssen SJMA, Brouwers T, van Roozendaal C, Vuister T, de Jongh A. The effect of EMDR versus EMDR 2.0 on emotionality and vividness of aversive memories in a non-clinical sample. Eur J Psychotraumatol. 2021 Sep 22;12(1):1956793. doi: 10.1080/20008198.2021.1956793. eCollection 2021.

  • van den Hout MA, Eidhof MB, Verboom J, Littel M, Engelhard IM. Blurring of emotional and non-emotional memories by taxing working memory during recall. Cogn Emot. 2014;28(4):717-27. doi: 10.1080/02699931.2013.848785. Epub 2013 Nov 7.

  • van Veen SC, van Schie K, Wijngaards-de Meij LD, Littel M, Engelhard IM, van den Hout MA. Speed Matters: Relationship between Speed of Eye Movements and Modification of Aversive Autobiographical Memories. Front Psychiatry. 2015 Apr 7;6:45. doi: 10.3389/fpsyt.2015.00045. eCollection 2015.

  • Yasar AB, Gundogmus I, Kubilay D, Alban Tunca G, Uygun E, Zat Ciftci Z, Kavakci O. The effectiveness of online Eye Movement Desensitization and Reprocessing 2.0 Group Protocol on post-traumatic stress disorders symptoms, depression, anxiety, and stress in individuals who have experienced a traffic accident: a randomized-controlled study. Front Psychiatry. 2025 May 9;16:1452206. doi: 10.3389/fpsyt.2025.1452206. eCollection 2025.

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticAnxiety DisordersDepressionWounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Control Group (3) vs EMDR 2.0 Group Intervention (3)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2022

First Posted

October 27, 2022

Study Start

October 14, 2022

Primary Completion

November 1, 2022

Study Completion

January 20, 2023

Last Updated

May 9, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations