Trauma, PsychologicalVaDDanCNCT06027658
Validation of a Dance as Therapy Program in Co-facilitation
An observational study of Trauma, Psychological and Depression, Anxiety, run by University of Franche-Comté at 1 site in France.
Trial summary
The objective is to validate a psychotherapeutic group protocol of dance as therapy created by LOBA association with a comparative non-randomized study. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Trauma, Psychological, Depression, Anxiety, Stress
- What is being tested?
- RECREATION therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2021to 18 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Migration-affected adult women (over 18 years old) victims of sexual violence, mostly born in Subsaharian African Countries.
Who may be able to join
- French-speaking
- Woman
- Over 18 years old
- Victim of sexual violence
Who cannot join
- Non-French-speaking person,
- Under 18 years old
- Not woman
- Not victim of sexual violence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Trauma, Psychological, Depression, Anxiety, Stress, Body Image, Quality of Life, Social Relationship
- Being tested
- RECREATION therapy
- Keywords
- Sexual violence, Trauma, Psychotherapy, Dance as therapy, Longitudinal study, Attachment, Mentalization
- Medical subject headings
- Psychological Trauma, Depression, Anxiety Disorders, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RECREATION therapyBehavioural
Dance as therapy program with speech and movement co-therapy via body activity.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: RECREATION therapy | |
| Long term participants | Individual receiving the RECREATION program for at least a month Receives: Behavioral: RECREATION therapy | |
| Professionals | Professionals associated with long term participants, working with them for standard support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: One interview per person between September 2022 and March 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start1 Nov 2021
- Primary completion18 Apr 2024
- Study completion18 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Trauma, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Franche-Comté
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lorraine, University of Roehampton, LOBA association
- Responsible party
- Principal investigator, Crystal Tomaszewski, University of Franche-Comté
- Investigators
- Rose-Angélique Belot, Study director, Université de Franche-Comté, FrCrystal Tomaszewski, Principal investigator, Université de Franche-Comté, Université de Lorraine, LOBA, FrAziz Essadek, Study director, Université de Lorraine, FrChristophe Clesse, Study director, University of Roehampton, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027658
- Sponsor's protocol ID
- CERUBFC-2021-11-09-035
- Acronym
- VaDDanC
- Status last verified
- Dec 2024
- First submitted
- 1 Aug 2023
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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
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.
PubMed 37427835
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychotherapeutic Care of Women Victims of Sexual Violence, Longitudinal Comparative Study and Therapeutic Evaluation of a Dance as Therapy Program
- ClinicalTrials.gov ID
- NCT06027658
- Acronym / sponsor ID
- VaDDanC / CERUBFC-2021-11-09-035
- Conditions
- Trauma, Psychological, Depression, Anxiety, Stress, Body Image, Quality of Life, Social Relationship
- Keywords
- Sexual violence, Trauma, Psychotherapy, Dance as therapy, Longitudinal study, Attachment, Mentalization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of Franche-ComtéUniversity, hospital or other
- Collaborators
- University of Lorraine, University of Roehampton, LOBA association
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 18 Apr 2024 (actual)
- Study completion
- 18 Apr 2024 (actual)
- First posted
- 7 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective is to validate a psychotherapeutic group protocol of dance as therapy created by LOBA association with a comparative non-randomized study.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non participants | – | –Individuals receiving the standard support for victims of sexual violence (e.g. medical, social, and legal assistance, individual psychotherapy) |
| Participants | – | Behavioral: RECREATION therapyIndividuals receiving the RECREATION program in addition to standard support for victims of sexual violence |
| Long term participants | – | Behavioral: RECREATION therapyIndividual receiving the RECREATION program for at least a month |
| Professionals | – | –Professionals associated with long term participants, working with them for standard support |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Migration-affected adult women (over 18 years old) victims of sexual violence, mostly born in Subsaharian African Countries.
Key inclusion criteria (4 listed)
- French-speaking
- Woman
- Over 18 years old
- Victim of sexual violence
Key exclusion criteria (4 listed)
- Non-French-speaking person,
- Under 18 years old
- Not woman
- Not victim of sexual violence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RECREATION therapyDance as therapy program with speech and movement co-therapy via body activity. | Behavioural | Long term participants, Participants |
Primary outcome
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.
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.
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
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
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
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.
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.
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.
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Results publicationTomaszewski, 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
- Results publication: PubMed 37427835Tomaszewski 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rose-Angélique Belot study director
Université de Franche-Comté, Fr
Crystal Tomaszewski principal investigator
Université de Franche-Comté, Université de Lorraine, LOBA, Fr
Aziz Essadek study director
Université de Lorraine, Fr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma, Psychological and Depression, Anxiety, run by University of Franche-Comté at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of participants presenting an improvement in PCLS scores at 6 months (time frame: 6 months period between January 2022 and April 2024). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06027658, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.