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Completed

NCT Number: NCT06027658

Validation of a Dance as Therapy Program in Co-facilitation

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

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Key information

Conditions

Trauma, Psychological Anxiety Disorders Attachment Disorder Behavior Behavioral Symptoms Body Image Depression Depression, Anxiety Mental Disorders Psychological Trauma Quality of Life Social Relationship Stress Stress Disorders, Traumatic Trauma and Stressor Related Disorders Wounds and Injuries

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

LOBA

Paris, 75006, France

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RECREATION therapy

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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

Sponsors and collaborators

Lead sponsor

University of Franche-Comté

Other

Collaborators

  • LOBA association
  • University of Lorraine
  • University of Roehampton

Registry information

Official study title

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

Acronym: VaDDanC

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 7, 2023
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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