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NCT05596903 Clinical Trial

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

Post Traumatic Stress Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05596903
Other study ID # TBA2021
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 14, 2022
Est. completion date January 20, 2023

Study information
Verified date May 2023
Source Academy of Therapeutic Sciences, Turkey
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 77
Est. completion date January 20, 2023
Est. primary completion date November 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• EMDR 2.0 group protocol
EMDR 2.0 group protocol
• Mhgap stress module
Mhgap stress module

Locations
Country Name City State
Turkey Academy of Therapeutic Sciences Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Academy of Therapeutic Sciences, Turkey

Country where clinical trial is conducted

Turkey, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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/10.1177/216

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. — View Citation

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 a — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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/fp — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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