- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06027658
Validation of a Dance As Therapy Program in Co-facilitation (VaDDanC)
Psychotherapeutic Care of Women Victims of Sexual Violence, Longitudinal Comparative Study and Therapeutic Evaluation of a Dance As Therapy Program
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This present research is a prospective longitudinal monocentric comparative study of an alternative, non-pharmacological therapy. It is a controlled, non-randomized, and experimental study in which half of the participants benefit from an additional program with speech and movement co-therapy via body activity, and the other half only benefit from standard support (e.g. medical, social, and legal assistance, individual psychotherapy).
The effect of this program will be examined across three dimensions:
- A clinical trial of N=80 participants to compare symptom improvement between individuals receiving the standard support for victims of sexual violence (N=40) and those receiving, in addition, the RECREATION program (N=40).
- A longitudinal evaluation of physiological conditions, psychological traits, and social well-being of RECREATION workshop attendees (N=10) versus victims not participating in said workshops (N=10).
- A qualitative analysis of interviews with program participants and their associated professionals (data saturation sample size).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75006
- LOBA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- French-speaking
- Woman
- Over 18 years old
- Victim of sexual violence
Exclusion Criteria:
- Non-French-speaking person,
- Under 18 years old
- Not woman
- Not victim of sexual violence
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Non participants
Individuals receiving the standard support for victims of sexual violence (e.g.
medical, social, and legal assistance, individual psychotherapy)
|
|
|
Participants
Individuals receiving the RECREATION program in addition to standard support for victims of sexual violence
|
Dance as therapy program with speech and movement co-therapy via body activity.
|
|
Long term participants
Individual receiving the RECREATION program for at least a month
|
Dance as therapy program with speech and movement co-therapy via body activity.
|
|
Professionals
Professionals associated with long term participants, working with them for standard support
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of participants presenting an improvement in PCLS scores at 6 months
Time Frame: 6 months period between January 2022 and April 2024
|
Posttraumatic stress disorder checklist (PCLS) scores range from 0 to 85; a higher score means a worse outcome.
|
6 months period between January 2022 and April 2024
|
|
Rate of participants presenting an improvement in DASS-21 scores at 6 months
Time Frame: 6 months period between January 2022 and April 2024
|
Depression, Anxiety, and Stress Scale in 21 (DASS-21) items scores range from 0 to 63; a higher score means a worse outcome.
|
6 months period between January 2022 and April 2024
|
|
Rate of participants presenting an improvement in QSCPGS scores at 6 months
Time Frame: 6 months period between January 2022 and April 2024
|
Body satisfaction and global self-perception questionnaire (QSCPGS) scores range from -100 to +100; a higher score means a better outcome
|
6 months period between January 2022 and April 2024
|
|
Rate of participants presenting an improvement in SF-36 scores at 6 months
Time Frame: 6 months period between January 2022 and April 2024
|
Short Form Health Survey in 36 items (SF-36) scores range from 0 to 100; a higher score means a better outcome
|
6 months period between January 2022 and April 2024
|
|
Rate of participants presenting an improvement in SSQ6 scores at 6 months
Time Frame: 6 months period between January 2022 and April 2024
|
Social Support Questionnaire in 6 items (SSQ6) scores range from 0 to 54 for the availability subscale and from 6 to 36 for the satisfaction subscale.
For both subscales, a higher score means a better outcome
|
6 months period between January 2022 and April 2024
|
|
Rate of participants presenting a change in RSQ score at 6 months
Time Frame: 6 months period between January 2022 and April 2024
|
Relationship Scales Questionnaire (RSQ) scores give an attachment profile, attachment strategies and a self and other model.
|
6 months period between January 2022 and April 2024
|
|
Rate of participants presenting an improvement in RFQ8 score at 6 months
Time Frame: 6 months period between January 2022 and April 2024
|
Reflexive Functioning Questionnaire in 8 items (RFQ8) scores range from 0 to 18; a higher score means a worse outcome.
|
6 months period between January 2022 and April 2024
|
|
Number of participants presenting an improvement in Rorschach protocol at 1 year
Time Frame: A year between April 2022 and December 2023
|
Rorschach protocols are interpreted both qualitatively and quantitatively (psychogram).
This outcome focuses on trauma symptomatology.
|
A year between April 2022 and December 2023
|
|
Number of participants presenting an improvement in AAI scores at 1 year
Time Frame: A year between April 2022 and December 2023
|
Adult Attachment Interview (AAI) scores range from 0 to 90; a higher score means a better outcome.
|
A year between April 2022 and December 2023
|
|
Number of identical themes in participants' and professionals' semi-structured interviews
Time Frame: One interview per person between September 2022 and March 2023
|
Number of identical themes in participants' and professionals' semi-structured interviews
|
One interview per person between September 2022 and March 2023
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Rose-Angélique Belot, Université de Franche-Comté, Fr
- Principal Investigator: Crystal Tomaszewski, Université de Franche-Comté, Université de Lorraine, LOBA, Fr
- Study Director: Aziz Essadek, Université de Lorraine, Fr
- Study Director: Christophe Clesse, University of Roehampton, UK
Publications and helpful links
General Publications
- Tomaszewski C, Belot RA, Essadek A, Onumba-Bessonnet H, Clesse C. Impact of dance therapy on adults with psychological trauma: a systematic review. Eur J Psychotraumatol. 2023;14(2):2225152. doi: 10.1080/20008066.2023.2225152.
- Tomaszewski, C., Essadek, A., Onumba-Bessonnet, H., Clesse, C. et Belot, R.-A. (2024). Violences sexuelles, traumatismes et mentalisation, Etude de la dynamique psychique à partir du cas Hélène. L'Evolution Psychiatrique. https://doi.org/10.1016/j.evopsy.2024.06.002
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CERUBFC-2021-11-09-035
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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