Clinical trial NCT06027658: Validation of a Dance As Therapy Program in Co-facilitation
Official title: Psychotherapeutic Care of Women Victims of Sexual Violence, Longitudinal Comparative Study and Therapeutic Evaluation of a Dance As Therapy Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma, Psychological
Depression, Anxiety
Stress
Body Image
Quality of Life
Social Relationship
Attachment Disorder
Keywords: Sexual violence
Trauma
Psychotherapy
Dance as therapy
Longitudinal study
Attachment
Mentalization
Lead sponsor: University of Franche-Comté
Sponsor class: OTHER
Collaborators: name: University of Lorraine
name: University of Roehampton
name: LOBA association
First posted: 2023-09-07
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Migration-affected adult women (over 18 years old) victims of sexual violence, mostly born in Subsaharian African Countries.

Brief summary: The objective is to validate a psychotherapeutic group protocol of dance as therapy created by LOBA association with a comparative non-randomized study.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Rate of participants presenting an improvement in PCLS scores at 6 months
timeFrame: 6 months period between January 2022 and April 2024
measure: Rate of participants presenting an improvement in DASS-21 scores at 6 months
timeFrame: 6 months period between January 2022 and April 2024
measure: Rate of participants presenting an improvement in QSCPGS scores at 6 months
timeFrame: 6 months period between January 2022 and April 2024
measure: Rate of participants presenting an improvement in SF-36 scores at 6 months
timeFrame: 6 months period between January 2022 and April 2024
measure: Rate of participants presenting an improvement in SSQ6 scores at 6 months
timeFrame: 6 months period between January 2022 and April 2024
measure: Rate of participants presenting a change in RSQ score at 6 months
timeFrame: 6 months period between January 2022 and April 2024
measure: Rate of participants presenting an improvement in RFQ8 score at 6 months
timeFrame: 6 months period between January 2022 and April 2024
measure: Number of participants presenting an improvement in Rorschach protocol at 1 year
timeFrame: A year between April 2022 and December 2023
measure: Number of participants presenting an improvement in AAI scores at 1 year
timeFrame: A year between April 2022 and December 2023
measure: Number of identical themes in participants' and professionals' semi-structured interviews
timeFrame: One interview per person between September 2022 and March 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: LOBA
Study officials:
affiliation: Université de Franche-Comté, Fr
name: Rose-Angélique Belot
role: STUDY_DIRECTOR
affiliation: Université de Franche-Comté, Université de Lorraine, LOBA, Fr
name: Crystal Tomaszewski
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Lorraine, Fr
name: Aziz Essadek
role: STUDY_DIRECTOR
affiliation: University of Roehampton, UK
name: Christophe Clesse
role: STUDY_DIRECTOR
References:
citation: 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
citation: 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.