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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06027658
Other study ID # CERUBFC-2021-11-09-035
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2021
Est. completion date May 31, 2024

Study information

Verified date August 2023
Source University of Franche-Comté
Contact Crystal Tomaszewski
Phone +33783012669
Email crystal.tomaszewski@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 65
Est. completion date May 31, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - French-speaking women over 18 years old, victims of sexual violence Exclusion Criteria: - Non-French-speaking person, under 18 years old, men, not victims of sexual violence

Study Design


Intervention

Behavioral:
RECREATION therapy
Dance as therapy program with speech and movement co-therapy via body activity.

Locations

Country Name City State
France LOBA Paris

Sponsors (4)

Lead Sponsor Collaborator
University of Franche-Comté LOBA association, University of Lorraine, University of Roehampton

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of participants presenting an improvement in PCLS scores at 6 months 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
Primary Rate of participants presenting an improvement in DASS-21 scores at 6 months 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
Primary Rate of participants presenting an improvement in QSCPGS scores at 6 months 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
Primary Rate of participants presenting an improvement in SF-36 scores at 6 months 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
Primary Rate of participants presenting an improvement in SSQ6 scores at 6 months 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
Primary Rate of participants presenting a change in RSQ score at 6 months 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
Primary Rate of participants presenting an improvement in RFQ8 score at 6 months 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
Primary Number of participants presenting an improvement in Rorschach protocol at 1 year Rorschach protocols are interpreted both qualitatively and quantitatively (psychogram). This outcome focuses on trauma symptomatology. A year between April 2022 and December 2023
Primary Number of participants presenting an improvement in AAI scores at 1 year 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
Primary Number of identical themes in participants' and professionals' semi-structured interviews Number of identical themes in participants' and professionals' semi-structured interviews One interview per person between September 2022 and March 2023
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