NCT06027658

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 7, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2024

Completed
Last Updated

December 9, 2024

Status Verified

December 1, 2024

Enrollment Period

2.5 years

First QC Date

August 1, 2023

Last Update Submit

December 4, 2024

Conditions

Keywords

Sexual violenceTraumaPsychotherapyDance as therapyLongitudinal studyAttachmentMentalization

Outcome Measures

Primary Outcomes (10)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (4)

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

Long term participants

Individual receiving the RECREATION program for at least a month

Behavioral: RECREATION therapy

Professionals

Professionals associated with long term participants, working with them for standard support

Interventions

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

Long term participantsParticipants

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Migration-affected adult women (over 18 years old) victims of sexual violence, mostly born in Subsaharian African Countries.

You may qualify if:

  • French-speaking
  • Woman
  • Over 18 years old
  • Victim of sexual violence

You may not qualify if:

  • Non-French-speaking person,
  • Under 18 years old
  • Not woman
  • Not victim of sexual violence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LOBA

Paris, 75006, France

Location

Related Publications (2)

  • Tomaszewski, C., Essadek, A., Onumba-Bessonnet, H., Clesse, C. et Belot, R.-A. (2024). Violences sexuelles, traumatismes et mentalisation, Etude de la dynamique psychique à partir du cas Hélène. L'Evolution Psychiatrique. https://doi.org/10.1016/j.evopsy.2024.06.002

    BACKGROUND
  • 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.

    PMID: 37427835BACKGROUND

MeSH Terms

Conditions

Psychological TraumaDepressionAnxiety DisordersWounds and Injuries

Interventions

Recreation Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Rose-Angélique Belot

    Université de Franche-Comté, Fr

    STUDY DIRECTOR
  • Crystal Tomaszewski

    Université de Franche-Comté, Université de Lorraine, LOBA, Fr

    PRINCIPAL INVESTIGATOR
  • Aziz Essadek

    Université de Lorraine, Fr

    STUDY DIRECTOR
  • Christophe Clesse

    University of Roehampton, UK

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 1, 2023

First Posted

September 7, 2023

Study Start

November 1, 2021

Primary Completion

April 18, 2024

Study Completion

April 18, 2024

Last Updated

December 9, 2024

Record last verified: 2024-12

Locations