Validation of a Dance As Therapy Program in Co-facilitation

Completed

• Conditions: Social Relationship; Trauma, Psychological; Depression, Anxiety; Stress; Body Image; Quality of Life; Attachment Disorder
• Interventions: Behavioral: RECREATION therapy

• Registration Number: NCT06027658
• Lead Sponsor: University of Franche-Comté

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).

Study Timeline

• Study Start: 2021-11-01
• Study First Submitted: 2023-08-01
• Study First Submitted QC: 2023-08-30
• Study First Posted: 2023-09-07
• Primary Completion: 2024-04-18
• Study Completion: 2024-04-18
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 65

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants	RECREATION therapy	Individuals receiving the RECREATION program in addition to standard support for victims of sexual violence
Long term participants	RECREATION therapy	Individual receiving the RECREATION program for at least a month

Primary Outcome Measures

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

Trial Locations

Locations (1)

LOBA; 🇫🇷 Paris, France