Complex Post-Traumatic Stress DisorderNCT04594434
Eye Movement Desensitization and Reprocessing (EMDR) in Complex Psychotrauma
A study testing Scale SUD, VOC scale and DES II scale in people with Complex Post-Traumatic Stress Disorder, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
This study wants to demonstrate the effectiveness of combining a positive memory with "recommended" therapy based on EMDR in reducing the disturbance that patients with complex psychotrauma may experience. The positive memory will be called "benevolent memory" (SB) or "less worse memory" (SMP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Post-Traumatic Stress Disorder
- What is being tested?
- Scale SUD, VOC scale and DES II scale
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteFrance
- Study dates
- 12 Dec 2020to 26 Jul 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient suffering from a combination of a period of complex trauma and a disturbance triggered by situations in adulthood;
- Having signed an informed consent form to participate in the study.
Who cannot join
- Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision);
- Patient seeking legal benefit from participating in the study;
- Patient previously treated with EMDR;
- Patient unable to understand the information related to the study (linguistic, psychological, cognitive reason, etc.);
- Untreated epileptic patient;
- Patient with severe oculomotor disorders;
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- Patient in hypomanic phase;
- Patient treated with high dose corticosteroids;
- Patient with alcohol and / or drug misuse in the 7 days preceding inclusion;
- Pregnant or likely to be (of childbearing age, without effective contraception) or breastfeeding;
- Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
- Patient not beneficiary of a social security scheme.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficiency of the Use of Benevolent Memories in the EMDR Protocol in Complex Psychotrauma (Benevolence Study)
This study wants to demonstrate the effectiveness of combining a positive memory with "recommended" therapy based on EMDR in reducing the disturbance that patients with complex psychotrauma may experience. The positive memory will be called "benevolent memory" (SB) or "less worse memory" (SMP).
Read the detailed description
This is an interventional study, prospective, exploratory, comparative, randomized, controlled versus reference treatment protocol, open.
Patients will be seen 16 times for the purposes of the study. They will be hospitalized during therapy. Discharge from hospitalization occurs during follow-up depending on the patient's condition.
They will be evaluated over a period of 4 to 6 weeks between the start (Day 0 = Week 1) and the end of treatment (visit week 12). These visits will coincide with treatment sessions with the EMDR ± SB / SMP protocol, as part of the support of their complex psychotrauma. At the end of treatment, the patient will be evaluated during follow-up visits at Month 1, Month 3 and Month 6.
- Conditions
- Complex Post-Traumatic Stress Disorder
- Being tested
- Scale SUD, VOC scale, DES II scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scale SUDOther
Subjective Units of Distress Scale ou Subjective Units of Disturbance Scale is a scale of subjective appreciation of emotions
VOC scaleOther
The VOC (Validity Of Cognition) scale is a scale of value given to cognition.
DES II scaleOther
The Dissociative Experiences Scale (DES), which is translated as the Dissociative Experiences Scale, is a self-questionnaire to assess the frequency of various dissociative symptoms in the patient's daily life.
| Study group | Role | What they receive |
|---|---|---|
| protocol EMDR + SB / SMP protocol (adjusted) | Experimental | Association of a positive memory with the "recommended" therapy based on EMDR. Receives: Other: Scale SUD; Other: VOC scale; Other: DES II scale |
| protocol EMDR (standard). | Active comparator | "recommended" therapy based on EMDR. Receives: Other: Scale SUD; Other: VOC scale; Other: DES II scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of the combination of SB and / or PMS with EMDR technique on reducing the disturbance experienced by patients with complex psychotrauma.
Percentage of patients with a 50% reduction in the SUD score(44/5000 measured by the SUD scale ranging from 0 to 10) at the end of the 3rd "active" EMDR session compared to the pre-treatment score of the 1st "active" session
Measured: 6 months
Secondary outcomes (2)
Disturbance felt
The % of patients responding to therapy (with SUD scores = 0 and VOC = 7) at M1, M3 and M6 will be compared between the 2 groups by a Cochran-Mantel-Haenszel test.
Measured: 6 months
Level of dissociation
The change in the level of dissociation by the DES II scale (score from 0 to 100) after therapy will be compared between the 2 groups by an analysis of covariance with adjustment for the score at inclusion;
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start12 Dec 2020
- Primary completion26 Jul 2022
- Study completion26 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04594434
- Sponsor's protocol ID
- 2020-A01914-35
- Status last verified
- Aug 2022
- First submitted
- 13 Oct 2020
- Last updated
- 17 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of the Use of Benevolent Memories in the EMDR Protocol in Complex Psychotrauma (Benevolence Study)
- ClinicalTrials.gov ID
- NCT04594434
- Acronym / sponsor ID
- 2020-A01914-35
- Conditions
- Complex Post-Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 12 Dec 2020 (actual)
- Primary completion
- 26 Jul 2022 (actual)
- Study completion
- 26 Jul 2022 (actual)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study wants to demonstrate the effectiveness of combining a positive memory with "recommended" therapy based on EMDR in reducing the disturbance that patients with complex psychotrauma may experience. The positive memory will be called "benevolent memory" (SB) or "less worse memory" (SMP).
Detailed description
This is an interventional study, prospective, exploratory, comparative, randomized, controlled versus reference treatment protocol, open.
Patients will be seen 16 times for the purposes of the study. They will be hospitalized during therapy. Discharge from hospitalization occurs during follow-up depending on the patient's condition.
They will be evaluated over a period of 4 to 6 weeks between the start (Day 0 = Week 1) and the end of treatment (visit week 12). These visits will coincide with treatment sessions with the EMDR ± SB / SMP protocol, as part of the support of their complex psychotrauma. At the end of treatment, the patient will be evaluated during follow-up visits at Month 1, Month 3 and Month 6.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| protocol EMDR + SB / SMP protocol (adjusted) | Experimental | Other: Scale SUD, Other: VOC scale, Other: DES II scaleAssociation of a positive memory with the "recommended" therapy based on EMDR. |
| protocol EMDR (standard). | Active comparator | Other: Scale SUD, Other: VOC scale, Other: DES II scale"recommended" therapy based on EMDR. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient suffering from a combination of a period of complex trauma and a disturbance triggered by situations in adulthood;
- Having signed an informed consent form to participate in the study.
Key exclusion criteria (12 listed)
- Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision);
- Patient seeking legal benefit from participating in the study;
- Patient previously treated with EMDR;
- Patient unable to understand the information related to the study (linguistic, psychological, cognitive reason, etc.);
- Untreated epileptic patient;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scale SUDSubjective Units of Distress Scale ou Subjective Units of Disturbance Scale is a scale of subjective appreciation of emotions | Other | protocol EMDR (standard)., protocol EMDR + SB / SMP protocol (adjusted) |
| VOC scaleThe VOC (Validity Of Cognition) scale is a scale of value given to cognition. | Other | protocol EMDR (standard)., protocol EMDR + SB / SMP protocol (adjusted) |
| DES II scaleThe Dissociative Experiences Scale (DES), which is translated as the Dissociative Experiences Scale, is a self-questionnaire to assess the frequency of various dissociative symptoms in the patient's daily life. | Other | protocol EMDR (standard)., protocol EMDR + SB / SMP protocol (adjusted) |
Primary outcome
Effectiveness of the combination of SB and / or PMS with EMDR technique on reducing the disturbance experienced by patients with complex psychotrauma.
Time frame: 6 months
Percentage of patients with a 50% reduction in the SUD score(44/5000 measured by the SUD scale ranging from 0 to 10) at the end of the 3rd "active" EMDR session compared to the pre-treatment score of the 1st "active" session
2 secondary outcomes
Disturbance felt
Time frame: 6 months
Level of dissociation
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scale SUD, VOC scale and DES II scale in people with Complex Post-Traumatic Stress Disorder, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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 2 inclusion and 12 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 17 Aug 2022. 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 France. 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?
Effectiveness of the combination of SB and / or PMS with EMDR technique on reducing the disturbance experienced by patients with complex psychotrauma. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2022.