NCT06718387

Brief Summary

Evaluation of the impact of a psycho-education program for victims of sexual violence, to determine the most efficient model to patients.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Apr 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Apr 2023Dec 2026

Study Start

First participant enrolled

April 1, 2023

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 5, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

3.5 years

First QC Date

November 29, 2024

Last Update Submit

March 13, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Evaluation of impact on quality of life (QoL) concerning participation in this psychoeducation 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

    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

    Well-being evalutation by Warwick-Edinburgh scale (WEMWBS)

    6 months after the end of program

Study Arms (2)

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

Other: PsychoEducation Program

Interventions

6 sessions of PsychoEducational Program

With group intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At the suggestion of CRP therapists,
  • Patient treated at the CRP having been exposed to sexual violence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Charles PERRENS

Bordeaux, 33076, France

RECRUITING

Related Publications (3)

  • 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.

    PMID: 31421141BACKGROUND
  • 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.

    PMID: 27085856BACKGROUND
  • 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.

    PMID: 25219804BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Chantal BERGEY

    Charles Perrens

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2024

First Posted

December 5, 2024

Study Start

April 1, 2023

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations