AzTrials
AzTrials

Post Traumatic Stress DisorderNCT05596903

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

A study testing EMDR 2.0 group protocol and Mhgap stress module in people with Post Traumatic Stress Disorder, run by Academy of Therapeutic Sciences, Turkey at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Post Traumatic Stress Disorder
What is being tested?
EMDR 2.0 group protocol and Mhgap stress module
Could I receive a placebo?
No, everyone receives an active treatment
How many people
77 participants
Where
1 siteTurkey (Türkiye)
Study dates
14 Oct 2022to 20 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Academy of Therapeutic Sciences

    Istanbul

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
EMDR 2.0 group protocol, Mhgap stress module
Keywords
EMDR, Post-traumatic stress disorder, Anxiety, Depression, Stress, Trauma
Medical subject headings
Stress Disorders, Post-Traumatic, Anxiety Disorders, Depression, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EMDR 2.0 group protocolOther

    EMDR 2.0 group protocol

  • Mhgap stress moduleOther

    Mhgap stress module

Study groups in NCT05596903
Study groupRoleWhat they receive
EMDR 2.0ExperimentalEMDR 2.0 Online Group protocol will be administered.
Receives: Other: EMDR 2.0 group protocol
ControlActive comparatorMental Health Gap Action Programme (mhGAP) will be administered.
Receives: Other: Mhgap stress module

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 1-week and 1-month follow-up

  2. 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.

    Measured: 1-week and 1-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2022
  2. Study start14 Oct 2022
  3. Primary completion1 Nov 2022
  4. Study completion20 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Control Group (3) vs EMDR 2.0 Group Intervention (3)
Masking
Single blind
Who is masked
Participant
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05596903
Sponsor's protocol ID
TBA2021
Status last verified
May 2023
First submitted
21 Oct 2022
Last updated
9 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21961947

  • 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.

    PubMed 23892070

  • 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

  • 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.

    PubMed 31125845

  • 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.

    PubMed 29163311

  • 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.

    PubMed 30514434

  • 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.

    PubMed 30465479

  • 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.

    PubMed 34567439

  • 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.

    PubMed 24199660

  • 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.

    PubMed 25904871

  • 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.

    PubMed 40417270

Questions about this trial

What is this clinical trial studying?

A study testing EMDR 2.0 group protocol and Mhgap stress module in people with Post Traumatic Stress Disorder, run by Academy of Therapeutic Sciences, Turkey at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) (time frame: 1-week and 1-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05596903, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in