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

Primary Purpose

Post Traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
EMDR 2.0 group protocol
Mhgap stress module
Sponsored by
Academy of Therapeutic Sciences, Turkey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder focused on measuring EMDR, Post-traumatic stress disorder, Anxiety, Depression, Stress, Trauma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Academy of Therapeutic Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EMDR 2.0

Control

Arm Description

EMDR 2.0 Online Group protocol will be administered.

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

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Full Information

First Posted
October 21, 2022
Last Updated
May 7, 2023
Sponsor
Academy of Therapeutic Sciences, Turkey
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1. Study Identification

Unique Protocol Identification Number
NCT05596903
Brief Title
Effect of Eye Movement Desensitization and Reprocessing Therapy 2.0 Online Group Protocol
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
October 14, 2022 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
January 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Academy of Therapeutic Sciences, Turkey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder
Keywords
EMDR, Post-traumatic stress disorder, Anxiety, Depression, Stress, Trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Control Group (3) vs EMDR 2.0 Group Intervention (3)
Masking
Participant
Masking Description
Single
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EMDR 2.0
Arm Type
Experimental
Arm Description
EMDR 2.0 Online Group protocol will be administered.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Mental Health Gap Action Programme (mhGAP) will be administered.
Intervention Type
Other
Intervention Name(s)
EMDR 2.0 group protocol
Intervention Description
EMDR 2.0 group protocol
Intervention Type
Other
Intervention Name(s)
Mhgap stress module
Intervention Description
Mhgap stress module
Primary Outcome Measure Information:
Title
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21)
Description
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
Time Frame
1-week and 1-month follow-up
Title
Impact of Events Scale Revised (IES-R)
Description
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.
Time Frame
1-week and 1-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Academy of Therapeutic Sciences
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21961947
Citation
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.
Results Reference
result
PubMed Identifier
23892070
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.
Results Reference
result
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/10.1177/2167702616687292
Results Reference
result
PubMed Identifier
31125845
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.
Results Reference
result
PubMed Identifier
29163311
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/fpsyg.2017.01937. eCollection 2017.
Results Reference
result
PubMed Identifier
30514434
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 analogue studies. J Behav Ther Exp Psychiatry. 2019 Jun;63:48-56. doi: 10.1016/j.jbtep.2018.11.006. Epub 2018 Nov 27.
Results Reference
result
PubMed Identifier
30465479
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.
Results Reference
result
PubMed Identifier
34567439
Citation
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.
Results Reference
result
PubMed Identifier
24199660
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.
Results Reference
result
PubMed Identifier
25904871
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/fpsyt.2015.00045. eCollection 2015.
Results Reference
result

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

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