Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:10 PM
Study NCT ID:
NCT06027658
Status:
COMPLETED
Last Update Posted:
2024-12-09
First Post:
2023-08-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validation of a Dance As Therapy Program in Co-facilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067073', 'term': 'Psychological Trauma'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057173', 'term': 'Recreation Therapy'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-04', 'studyFirstSubmitDate': '2023-08-01', 'studyFirstSubmitQcDate': '2023-08-30', 'lastUpdatePostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of participants presenting an improvement in PCLS scores at 6 months', 'timeFrame': '6 months period between January 2022 and April 2024', 'description': 'Posttraumatic stress disorder checklist (PCLS) scores range from 0 to 85; a higher score means a worse outcome.'}, {'measure': 'Rate of participants presenting an improvement in DASS-21 scores at 6 months', 'timeFrame': '6 months period between January 2022 and April 2024', 'description': 'Depression, Anxiety, and Stress Scale in 21 (DASS-21) items scores range from 0 to 63; a higher score means a worse outcome.'}, {'measure': 'Rate of participants presenting an improvement in QSCPGS scores at 6 months', 'timeFrame': '6 months period between January 2022 and April 2024', 'description': 'Body satisfaction and global self-perception questionnaire (QSCPGS) scores range from -100 to +100; a higher score means a better outcome'}, {'measure': 'Rate of participants presenting an improvement in SF-36 scores at 6 months', 'timeFrame': '6 months period between January 2022 and April 2024', 'description': 'Short Form Health Survey in 36 items (SF-36) scores range from 0 to 100; a higher score means a better outcome'}, {'measure': 'Rate of participants presenting an improvement in SSQ6 scores at 6 months', 'timeFrame': '6 months period between January 2022 and April 2024', 'description': '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'}, {'measure': 'Rate of participants presenting a change in RSQ score at 6 months', 'timeFrame': '6 months period between January 2022 and April 2024', 'description': 'Relationship Scales Questionnaire (RSQ) scores give an attachment profile, attachment strategies and a self and other model.'}, {'measure': 'Rate of participants presenting an improvement in RFQ8 score at 6 months', 'timeFrame': '6 months period between January 2022 and April 2024', 'description': 'Reflexive Functioning Questionnaire in 8 items (RFQ8) scores range from 0 to 18; a higher score means a worse outcome.'}, {'measure': 'Number of participants presenting an improvement in Rorschach protocol at 1 year', 'timeFrame': 'A year between April 2022 and December 2023', 'description': 'Rorschach protocols are interpreted both qualitatively and quantitatively (psychogram). This outcome focuses on trauma symptomatology.'}, {'measure': 'Number of participants presenting an improvement in AAI scores at 1 year', 'timeFrame': 'A year between April 2022 and December 2023', 'description': 'Adult Attachment Interview (AAI) scores range from 0 to 90; a higher score means a better outcome.'}, {'measure': "Number of identical themes in participants' and professionals' semi-structured interviews", 'timeFrame': 'One interview per person between September 2022 and March 2023', 'description': "Number of identical themes in participants' and professionals' semi-structured interviews"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sexual violence', 'Trauma', 'Psychotherapy', 'Dance as therapy', 'Longitudinal study', 'Attachment', 'Mentalization'], 'conditions': ['Trauma, Psychological', 'Depression, Anxiety', 'Stress', 'Body Image', 'Quality of Life', 'Social Relationship', 'Attachment Disorder']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': "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"}, {'pmid': '37427835', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The objective is to validate a psychotherapeutic group protocol of dance as therapy created by LOBA association with a comparative non-randomized study.', 'detailedDescription': '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).\n\nThe effect of this program will be examined across three dimensions:\n\n* 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).\n* 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).\n* A qualitative analysis of interviews with program participants and their associated professionals (data saturation sample size).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Migration-affected adult women (over 18 years old) victims of sexual violence, mostly born in Subsaharian African Countries.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* French-speaking\n* Woman\n* Over 18 years old\n* Victim of sexual violence\n\nExclusion Criteria:\n\n* Non-French-speaking person,\n* Under 18 years old\n* Not woman\n* Not victim of sexual violence'}, 'identificationModule': {'nctId': 'NCT06027658', 'acronym': 'VaDDanC', 'briefTitle': 'Validation of a Dance As Therapy Program in Co-facilitation', 'organization': {'class': 'OTHER', 'fullName': 'University of Franche-Comté'}, 'officialTitle': 'Psychotherapeutic Care of Women Victims of Sexual Violence, Longitudinal Comparative Study and Therapeutic Evaluation of a Dance As Therapy Program', 'orgStudyIdInfo': {'id': 'CERUBFC-2021-11-09-035'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non participants', 'description': 'Individuals receiving the standard support for victims of sexual violence (e.g. medical, social, and legal assistance, individual psychotherapy)'}, {'label': 'Participants', 'description': 'Individuals receiving the RECREATION program in addition to standard support for victims of sexual violence', 'interventionNames': ['Behavioral: RECREATION therapy']}, {'label': 'Long term participants', 'description': 'Individual receiving the RECREATION program for at least a month', 'interventionNames': ['Behavioral: RECREATION therapy']}, {'label': 'Professionals', 'description': 'Professionals associated with long term participants, working with them for standard support'}], 'interventions': [{'name': 'RECREATION therapy', 'type': 'BEHAVIORAL', 'description': 'Dance as therapy program with speech and movement co-therapy via body activity.', 'armGroupLabels': ['Long term participants', 'Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75006', 'city': 'Paris', 'country': 'France', 'facility': 'LOBA', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Rose-Angélique Belot', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Université de Franche-Comté, Fr'}, {'name': 'Crystal Tomaszewski', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Franche-Comté, Université de Lorraine, LOBA, Fr'}, {'name': 'Aziz Essadek', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Université de Lorraine, Fr'}, {'name': 'Christophe Clesse', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Roehampton, UK'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Franche-Comté', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Lorraine', 'class': 'OTHER'}, {'name': 'University of Roehampton', 'class': 'OTHER'}, {'name': 'LOBA association', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Crystal Tomaszewski', 'investigatorAffiliation': 'University of Franche-Comté'}}}}