- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06718387
Evaluation of the Impact of Participation in a Psycho-education Program for Victims of Sexual Violence (PE-VVS)
March 13, 2026 updated by: Centre Hospitalier Charles Perrens, Bordeaux
Evaluation of the impact of a psycho-education program for victims of sexual violence, to determine the most efficient model to patients.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chantal BERGEY, MD
- Phone Number: 05 56 56 35 78
- Email: cbergey@ch-perrens.fr
Study Contact Backup
- Name: Celine PELEAU
- Phone Number: 05 56 56 35 78
- Email: ctroadec@ch-perrens.fr
Study Locations
-
-
-
Bordeaux, France, 33076
- Recruiting
- Centre Hospitalier Charles Perrens
-
Contact:
- Chantal BERGEY, MD
- Phone Number: 05 56 56 35 78
- Email: cbergey@ch-perrens.fr
-
Contact:
- Celine PELEAU
- Phone Number: 05 56 56 35 78
- Email: ctroadec@ch-perrens.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- At the suggestion of CRP therapists,
- Patient treated at the CRP having been exposed to sexual violence
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Without group intervention
Patient refusing group care and/or assessment ended after the inclusion end dates
|
|
|
Experimental: With group intervention
Patient in agreement with group management and available for participation
|
6 sessions of PsychoEducational Program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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"
|
6 months after the end of program
|
|
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
|
6 months after the end of program
|
|
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)
|
6 months after the end of program
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Chantal BERGEY, Charles Perrens
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Shors 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.
- Shors 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2023
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
November 29, 2024
First Submitted That Met QC Criteria
December 4, 2024
First Posted (Actual)
December 5, 2024
Study Record Updates
Last Update Posted (Actual)
March 16, 2026
Last Update Submitted That Met QC Criteria
March 13, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR-BDX-AP 2023-08
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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