PtsdPE-VVSNCT06718387
Evaluation of the Impact of Participation in a Psycho-education Program for Victims of Sexual Violence
A study testing PsychoEducation Program in people with Ptsd and Sexual Violence, run by Centre Hospitalier Charles Perrens, Bordeaux at 1 site in France.
Trial summary
Evaluation of the impact of a psycho-education program for victims of sexual violence, to determine the most efficient model to patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ptsd, Sexual Violence, Therapeutic Alliance
- What is being tested?
- PsychoEducation Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At the suggestion of CRP therapists,
- Patient treated at the CRP having been exposed to sexual violence
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Charles PERRENS
Bordeaux, 33076
Chantal BERGEY, MD, 05 56 56 35 78, cbergey@ch-perrens.fr
Celine PELEAU, 05 56 56 35 78, ctroadec@ch-perrens.fr
About this study
Evaluation of the impact of a psycho-education program for victims of sexual violence, to determine the most efficient model to patients.
Read the detailed description
In 2022, CRP Sud NA set up a psycho-education group for victims of sexual violence (PE-VVS). Two groups were held, involving 10 patients:
- Average age = 35 (29-50)
- Average PCL5 before PE-VSS = 53 (31 - 63)
- Type of SV experienced
- In childhood or adolescence outside family environment
- Incest
- Rape in adulthood outside intimate relationship
- Rape by intimate partner A special feature of this therapeutic group is the involvment of the CRP's patient-partner. He took part in both design and facilitation of the sessions, along with the two CRP co-therapists (IDE / psychologist).
- Conditions
- Ptsd, Sexual Violence, Therapeutic Alliance
- Being tested
- PsychoEducation Program
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychoEducation ProgramOther
6 sessions of PsychoEducational Program
| Study group | Role | What they receive |
|---|---|---|
| Without group intervention | No intervention | Patient refusing group care and/or assessment ended after the inclusion end dates |
| With group intervention | Experimental | Patient in agreement with group management and available for participation Receives: Other: PsychoEducation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of impact on quality of life (QoL) concerning participation in this psychoeducation program
QoL measurement by Stages of Recovery Instrument "STORI"
Measured: 6 months after the end of program
Evaluation of impact on self-esteem of participation in this psychoeducation program
Self-esteem measurement by Rosenberg self-esteem scale
Measured: 6 months after the end of program
Evaluation of Impact on mental well-being of participation in this psychoeducation program
Well-being evalutation by Warwick-Edinburgh scale (WEMWBS)
Measured: 6 months after the end of program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start1 Apr 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PtsdStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Charles Perrens, Bordeaux
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Chantal BERGEY, Principal investigator, Charles Perrens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718387
- Sponsor's protocol ID
- CR-BDX-AP 2023-08
- Acronym
- PE-VVS
- Status last verified
- Mar 2026
- First submitted
- 29 Nov 2024
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Millon EM, Shors TJ. Taking neurogenesis out of the lab and into the world with MAP Train My Brain. Behav Brain Res. 2019 Dec 30;376:112154. doi: 10.1016/j.bbr.2019.112154. Epub 2019 Aug 14.
PubMed 31421141Shors TJ, Millon EM. Sexual trauma and the female brain. Front Neuroendocrinol. 2016 Apr;41:87-98. doi: 10.1016/j.yfrne.2016.04.001. Epub 2016 Apr 13.
PubMed 27085856Shors TJ, Olson RL, Bates ME, Selby EA, Alderman BL. Mental and Physical (MAP) Training: a neurogenesis-inspired intervention that enhances health in humans. Neurobiol Learn Mem. 2014 Nov;115:3-9. doi: 10.1016/j.nlm.2014.08.012. Epub 2014 Sep 9.
PubMed 25219804
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Participation in a Psycho-education Program for Victims of Sexual Violence
- ClinicalTrials.gov ID
- NCT06718387
- Acronym / sponsor ID
- PE-VVS / CR-BDX-AP 2023-08
- Conditions
- Ptsd, Sexual Violence, Therapeutic Alliance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Charles Perrens, BordeauxOther government
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Dec 2024 (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.
Evaluation of the impact of a psycho-education program for victims of sexual violence, to determine the most efficient model to patients.
Detailed description
In 2022, CRP Sud NA set up a psycho-education group for victims of sexual violence (PE-VVS). Two groups were held, involving 10 patients:
- Average age = 35 (29-50)
- Average PCL5 before PE-VSS = 53 (31 - 63)
- Type of SV experienced
- In childhood or adolescence outside family environment
- Incest
- Rape in adulthood outside intimate relationship
- Rape by intimate partner A special feature of this therapeutic group is the involvment of the CRP's patient-partner. He took part in both design and facilitation of the sessions, along with the two CRP co-therapists (IDE / psychologist).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Without group intervention | No intervention | –Patient refusing group care and/or assessment ended after the inclusion end dates |
| With group intervention | Experimental | Other: PsychoEducation ProgramPatient in agreement with group management and available for participation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At the suggestion of CRP therapists,
- Patient treated at the CRP having been exposed to sexual violence
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| PsychoEducation Program6 sessions of PsychoEducational Program | Other | With group intervention |
Primary outcome
Evaluation of impact on quality of life (QoL) concerning participation in this psychoeducation program
Time frame: 6 months after the end of program
QoL measurement by Stages of Recovery Instrument "STORI"
Evaluation of impact on self-esteem of participation in this psychoeducation program
Time frame: 6 months after the end of program
Self-esteem measurement by Rosenberg self-esteem scale
Evaluation of Impact on mental well-being of participation in this psychoeducation program
Time frame: 6 months after the end of program
Well-being evalutation by Warwick-Edinburgh scale (WEMWBS)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Background: PubMed 31421141Millon EM, Shors TJ. Taking neurogenesis out of the lab and into the world with MAP Train My Brain. Behav Brain Res. 2019 Dec 30;376:112154. doi: 10.1016/j.bbr.2019.112154. Epub 2019 Aug 14.
- Background: PubMed 27085856Shors TJ, Millon EM. Sexual trauma and the female brain. Front Neuroendocrinol. 2016 Apr;41:87-98. doi: 10.1016/j.yfrne.2016.04.001. Epub 2016 Apr 13.
- Background: PubMed 25219804Shors TJ, Olson RL, Bates ME, Selby EA, Alderman BL. Mental and Physical (MAP) Training: a neurogenesis-inspired intervention that enhances health in humans. Neurobiol Learn Mem. 2014 Nov;115:3-9. doi: 10.1016/j.nlm.2014.08.012. Epub 2014 Sep 9.
- Individual participant dataSharing planned: No
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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.
Chantal BERGEY principal investigator
Charles Perrens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PsychoEducation Program in people with Ptsd and Sexual Violence, run by Centre Hospitalier Charles Perrens, Bordeaux 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 1 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: looking for participants now, as of the sponsor's last update on 16 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chantal BERGEY, MD (05 56 56 35 78, cbergey@ch-perrens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of impact on quality of life (QoL) concerning participation in this psychoeducation program (time frame: 6 months after the end of program). The study lists 3 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 NCT06718387, which also lists 3 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 16 Mar 2026.