VaDDanC: Validation of a Dance as Therapy Program in Co-facilitation

Sponsor
University of Franche-Comté (Other)
Overall Status
Recruiting
CT.gov ID
NCT06027658
Collaborator
University of Lorraine (Other), University of Roehampton (Other), LOBA association (Other)
65
1
30.9
2.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: RECREATION therapy

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 Design

Study Type:
Observational
Anticipated Enrollment :
65 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Psychotherapeutic Care of Women Victims of Sexual Violence. Longitudinal Comparative Study and Therapeutic Evaluation of a Dance as Therapy Program.
Actual Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
May 31, 2024
Anticipated Study Completion Date :
May 31, 2024

Arms and Interventions

Arm 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

Behavioral: RECREATION therapy
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

Behavioral: RECREATION therapy
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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 LOBA Paris France 75006

Sponsors and Collaborators

  • University of Franche-Comté
  • University of Lorraine
  • University of Roehampton
  • LOBA association

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Crystal Tomaszewski, Principal Investigator, University of Franche-Comté
ClinicalTrials.gov Identifier:
NCT06027658
Other Study ID Numbers:
  • CERUBFC-2021-11-09-035
First Posted:
Sep 7, 2023
Last Update Posted:
Sep 7, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Crystal Tomaszewski, Principal Investigator, University of Franche-Comté
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 7, 2023