Validation of a Dance as Therapy Program in Co-facilitation

Quality of Life Clinical Trial

— VaDDanC  

Official title:

Psychotherapeutic Care of Women Victims of Sexual Violence. Longitudinal Comparative Study and Therapeutic Evaluation of a Dance as Therapy Program.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06027658
• Other study ID #: CERUBFC-2021-11-09-035
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Attachment Disorder
• Body Image
• Depression, Anxiety
• Psychological Trauma
• Quality of Life
• Stress
• Trauma, Psychological

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