Validation of a Dance As Therapy Program in Co-facilitation (VaDDanC)

December 4, 2024 updated by: Crystal Tomaszewski, University of Franche-Comté

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

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

Study Overview

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

Observational

Enrollment (Actual)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Paris, France, 75006
        • LOBA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Actual)

April 18, 2024

Study Completion (Actual)

April 18, 2024

Study Registration Dates

First Submitted

August 1, 2023

First Submitted That Met QC Criteria

August 30, 2023

First Posted (Actual)

September 7, 2023

Study Record Updates

Last Update Posted (Estimated)

December 9, 2024

Last Update Submitted That Met QC Criteria

December 4, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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