The effectiveness of eye movement desensitization and reprocessing (EMDR) 2.0 and the Flash technique with post-traumatic stress disorder (PTSD) patients

ISRCTN	ISRCTN13100019
DOI	https://doi.org/10.1186/ISRCTN13100019
Secondary identifying numbers	NL79163.041.22

Submission date: 08/11/2022
Registration date: 10/11/2022
Last edited: 12/12/2024

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Background and study aims
Eye movement desensitization and reprocessing (EMDR) therapy is an evidence based treatment for patients suffering from a post-traumatic stress dissorder (PTSD). To investigate if EMDR can be delivered more effective and efficient, an adaptation of EMDR has been developed, called EMDR 2.0 therapy. A recent experimental study among participants without a PTSD diagnosis, suggests that EMDR 2.0 can be delivered more efficiently than standard EMDR therapy in reducing the emotionality and vividness of aversive memories. The Flash technique has originally been developed as a titration technique for patients who find the recall of the traumatic memory during EMDR therapy too disturbing. Currently, is has evolved to a stand-alone trauma treatment. Previous research on the Flash technique showed that it was effective in reducing psychiatric symptoms and vividness and emotionality of aversive memories. These previous studies on EMDR 2.0 and the Flash technique show promising results, but a controlled study with patients diagnosed with PTSD is still lacking. The current study is a randomized controlled trial that aims to investigate EMDR 2.0 therapy and the Flash technique among PTSD patients by comparing them to standard EMDR therapy as standard evidence based treatment. The primary aims are to investigate if EMDR 2.0 and the Flash technique are effective in reducing (complex) PTSD symptoms and diagnosis, and to investigate which treatment is most effective. Also, a primary aim is to investigate which treatment is most efficient in reducing subjective disturbance of traumatic memories and in reducing PTSD symptoms. The secondary aims are to investigate the effectiveness in reducing comorbid psychiatric symptoms, to investigate treatmen acceptability, and to investigate moderators of treatment effectiveness.

Who can participate?
Patients aged 18 years and older, with a primary diagnosis of PTSD, an estimated IQ of above 80, and sufficient understanding of the Dutch language.

What does the study involve?
Participants are randomly assigned to one of three treatment arms: EMDR therapy, EMDR 2.0 therapy, or the Flash technique. All treatments start with a 90 minute case conceptualization session, following six weekly 60-minute treatment sessions (EMDR, EMDR 2.0, or Flash). Before, during, and until 12 weeks after treatment, several symptoms and constructs will be measured. Including: PTSD symptoms and diagnosis, complex PTSD symptoms and diagnosis, depressive symptoms, dissociative symptoms, general psychiatric symptoms, experiential avoidance, and treatment acceptability.

What are the possible benefits and risks of participating?
There are no safety risks involved with the treatments. Previous research involving EMDR therapy, EMDR 2.0 therapy, and the Flash technique has not led to negative consequences. In fact, previous clinical studies show less dysregulation in EMDR conditions as opposed to waitlist conditions for example. When compared to regular treatment for PTSD, the additional time investment for the current study mainly consists of filling out the questionnaires. They will be adminstered a total of 12 times and take around 20-30 minutes, which comes down to a maximum total of 6 hours. A potential benefit for participants is that the delivered treatment can reduce their symptoms, although this is not certain. Patients who still meet the diagnostic criteria for PTSD after the study is completed, will be offered regular treatment. If participants are on a waitinglist for regular treatment, they will keep their place on the waitinglist if they still show symptoms after the course of the study.

Where is the study run from?
The study is run from the Altrecht Academic Anxiety Center in Utrecht, the Netherlands.

When is the study starting and how long is it expected to run for?
April 2021 to October 2026

Who is funding the study?
Altrecht Academic Anxiety Center (the Netherlands)
EMDR Research Foundation (USA)
Vereniging EMDR Nederland (Dutch EMDR association)

Who is the main contact?
Valentijn Alting van Geusau
v.alting-van-geusau@altrecht.nl

Contact information

Dr Suzy Matthijssen
Principal Investigator

Nieuwe Houtenseweg 12
Utrecht
3512 SH
Netherlands

ORCID ID	0000-0002-5537-112X
Phone	+31 (0)30 2308790
Email	s.matthijssen@altrecht.nl

Mr Valentijn Alting van Geusau
Public

Nieuwe Houtenseweg 12
Utrecht
3512 SH
Netherlands

Phone	+31 (0)30 2308790
Email	v.alting-van-geusau@altrecht.nl

Study information

Study design	Monocenter interventional parallel group open randomized controlled superiority trial with three treatment arms
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other therapist office
Study type	Treatment
Participant information sheet	42734 PIS v3.pdf
Scientific title	The effectiveness of EMDR vs. EMDR 2.0 vs. Flash technique in the treatment of patients diagnosed with PTSD: A randomized controlled trial
Study acronym	ENHANCE
Study hypothesis	We expect eye movement desensitization and reprocessing (EMDR) 2.0 therapy to be more efficient than EMDR therapy in treating traumatic memories and post-traumatic stress disorder (PTSD) symptoms. We do not have prior expectations with regard to the differential effectiveness of EMDR therapy and EMDR 2.0. With regard to the effectiveness and efficiency of the Flash technique compared to EMDR or EMDR 2.0, we do not have any prior expectations as an RCT among PTSD patients has not yet been conducted. We do expect that the Flash technique will be rated as more acceptable by patients than EMDR therapy.
Ethics approval(s)	Approved 14/07/2022, Medical Research Ethics Committee (MREC) NedMec (Heidelberglaan 100,3584 CX, Utrecht, the Netherlands; +31 (0)88 7556376; metc@nedmec.nl), ref: NL79163.041.22
Condition	Treatment of (complex) PTSD symptoms in patients diagnosed with PTSD.
Intervention	Participants are randomly assigned to one of three treatment conditions using an online tool (sealedenvelope.com). There are two intervention groups and one control group. Participants in one intervention group will receive EMDR 2.0 therapy and participants in the other intervention group will receive the Flash technique. Participants in the control group will receive standard EMDR therapy. All conditions will consist of six weekly sessions, with a duration of 60 minutes. Follow up lasts 12 weeks.
Intervention type	Behavioural
Primary outcome measure	1. PTSD symptoms measured with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at baseline, post-treatment (4 weeks after the last treatment session) and follow-up (12 weeks after the last treamtent session) and the PTSD symptom Checklist for DSM-5 (PCL-5) at baseline, weekly during treatment phase and bi-weekly after the last treatment session until 12 week follow-up. 2. PTSD diagnosis measured with the CAPS-5 at baseline, post-treatment and follow-up. 3. Complex PTSD symptoms measured with the International Trauma Questionnaire (ITQ) at baseline, post-treatment and follow-up. 4. Complex PTSD diagnosis measured with the ITQ at baseline, post-treatment and follow-up.
Secondary outcome measures	1. Depressive symptoms measured with the Beck Depression Inventory-II (BDI-II) at baseline, weekly during the treatment phase and bi-weekly after the last treatment session until 12-week follow-up. 2. Dissociative symptoms measured with the Dissociative Experiences Scale (DES) at baseline, post-treatment and follow-up. 3. General psychiatric symptoms measured with the Brief Symptom Inventory (BSI) at baseline, weekly during the treatment phase and bi-weekly after the last treatment session until 12-week follow-up. 4. Experiential avoidance measured with the Acceptance and Action Questionnaire-II (AAQ-II) at baseline, weekly during the treatment phase and bi-weekly after the last treatment session until 12-week follow-up. 5. Treatment acceptability measured with four questions that measure several facets which could be grouped under treatment acceptability at the second week of treatment and two weeks after the last treatment session. 6. Treatment efficiency measured with intervention time needed to achieve a Subjective Units of Disturbance (SUD) score of 0 and amount of sessions needed to achieve clinically significant change and a cut-off score on the PCL-5. Intervention time and SUD scores will be measured at treatment sessions and the PCL-5 will be measured weekly during the treatment phase.
Overall study start date	01/04/2021
Overall study end date	31/10/2026

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	130
Participant inclusion criteria	1. A primary diagnosis of PTSD, administered with the CAPS-5. 2. A minimum age of 18 years old. 3. An estimated IQ of above 80. 4. Sufficient understanding of the Dutch language.
Participant exclusion criteria	1. The use of benzodiazepines is a contra-indication for treatment and will be tapered as much as possible before participation. Participants are prohibited to use benzodiazepines 24 hours before or after each treatment sessions. 2. The use of drugs during treatment. 3. The use of alcohol is allowed, with the exception of 24 hours before and after a treatment sessions. For the rest of the week, participants are allowed a maximum of 2 units. 4. Acute suicidality 5. Change in medication during the study or six weeks prior to participation, with the exception of tapering benzodiazepines.
Recruitment start date	17/10/2022
Recruitment end date	17/10/2026

Locations

Countries of recruitment

Netherlands

Study participating centre

Altrecht Academic Anxiety Center

Nieuwe Houtenseweg 12
Utrecht
3524 SH
Netherlands

Sponsor information

Utrecht University
University/education

Heidelberglaan 1
Utrecht
3584 CS
Netherlands

Phone	+31 (0)30 2534700
Email	info@uu.nl
Website	http://www.uu.nl/en
"ROR"	https://ror.org/04pp8hn57

Funders

Funder type

Other

Investigator initiated and funded

No information available

EMDR Research Foundation

No information available

Vereniging EMDR Nederland (Dutch EMDR Association)

No information available

Results and Publications

Intention to publish date	01/02/2027
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Three planned publications in high-impact peer-reviewed journals.
IPD sharing plan	The datasets generated and analysed during the current study will be available upon request from v.alting-van-geusau@altrecht.nl

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	version 3		10/11/2022	No	Yes
Protocol article		09/11/2023	01/12/2023	Yes	No

Additional files

42734 PIS v3.pdf

Editorial Notes

12/12/2024: The following changes were made:
1. The overall study end date was changed from 17/02/2026 to 31/10/2026.
2. The target number of participants was changed from 171 to 130.
3. The recruitment end date was changed from 17/10/2025 to 17/10/2026.
01/12/2023: Publication reference added.
16/02/2023: The study setting has been changed from ‘Other’.
10/11/2022: Trial's existence confirmed by NedMec