- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07670663
Effects of a Qi Gong Program on Dissociative Symptoms in Patients Who Have Experienced Childhood Trauma: a Randomized Controlled Trial (Qi-T) (Qi-T)
Effects of a Qi Gong Program on Dissociative Symptoms in Patients Who Have Experienced Childhood Trauma: a Randomized Controlled Trial
The goal of this clinical trial is to evaluate whether participation in 12 Qi Gong sessions (intervention group), compared with usual care without Qi Gong (control group), reduces dissociative symptoms, as measured by the Dissociative Experience Scale-II (DES-II), between T0 and T1, in outpatients hospitalized for psychiatric disorders related to aversive experiences during childhood.
The main questions it aims to answer are:
- a) To assess whether participation in the Qi Gong program leads to a reduction in symptoms related to complex trauma, b) To assess whether participation in the Qi Gong program leads to an increase in the level of mindfulness c) To explore whether the effect of the Qi Gong program on reducing dissociative symptoms varies according to participants' baseline level of dissociation (Dissociative Experiences Scale-II ) d) To explore whether the effect of the Qi Gong program on reducing dissociative symptoms is sustained over time e) To explore the experiences of patients who participated in the Qi Gong sessions following the intervention.
This is a randomized controlled trial with parallel groups:
- Intervention group: participation in 12 Qi Gong sessions led by a trained professional, in addition to standard care
- Control group: standard care, without access to Qi Gong sessions during the study period.
Participants will be required to:
- complete 3 questionnaires (DES-II, ITQ, MAAS)
- attend one Qi Gong session per week for 12 weeks (including a group debriefing) or receive standard care at a medical-psychological center (without Qi Gong)
- complete the same questionnaires (DES-II, ITQ, MAAS) after the 12 weeks
- complete the DES-II questionnaire 2 months later
Panoramica dello studio
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Olivier Martinez, Mr
- Numero di telefono: 0262 262570169
- Email: olivier.martinez@chu-reunion.fr
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- 18 years of age or older
- A score above the 10th percentile on the Dissociative Experience Scale-II (DES-II)
- A score above 2 on the ACE scale (Adverse Childhood Experiences by Felitti et al., 1998)
- A medical certificate attesting to the participant's fitness to practice Qigong
- A person enrolled in or receiving benefits from a social security program
- Free, informed, and written consent signed by the participant and the investigator (no later than the day of enrollment and prior to any examination required by the study).
Exclusion Criteria:
- In a suicidal crisis
- In a hallucinatory crisis
- Experiencing a major depressive episode
- Unstabilized
- Pregnant women
- Those who do not understand French
- Under guardianship or conservatorship
- Under judicial protection
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Qi-gong
One Qi Gong session per week for 12 weeks, in groups of six, led by a certified professional.
|
1 Qi Gong session per week for 12 weeks
|
|
Nessun intervento: Routine Care (without Qi Gong)
Routine care at a medical-psychological center (appointments with psychologists, doctors, and registered nurses scheduled as part of standard care), excluding participation in Qi Gong sessions
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Reduction in dissociative symptoms
Lasso di tempo: 3 months after enrollment
|
Symptoms of dissociation, as measured by the Dissociative Experiences Scale-II (DES-II), will be compared between the intervention group (Qi Gong sessions) and the control group (usual care without Qi Gong).
|
3 months after enrollment
|
|
To assess whether participation in the Qi-Gong program leads to a reduction in symptoms related to complex trauma
Lasso di tempo: 3 months after enrollment
|
Change in mean ITQ scores between T1 and T0 (T1-T0); this change will be calculated for each participant.
|
3 months after enrollment
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
To assess whether participation in the Qigong program leads to an increase in the level of mindfulness
Lasso di tempo: 3 months after enrollement
|
Change in mean MAAS scores between T1 and T0 (T1-T0); this change will be calculated for each participant.
|
3 months after enrollement
|
|
To investigate whether the effect of the Qigong program on reducing dissociative symptoms varies depending on participants' initial level of dissociation
Lasso di tempo: 3 months after enrollment
|
Change in the mean DES-II score between T1 and T0 (T1-T0), according to the baseline level of dissociation, as measured by the DES-II.
This change will be calculated for each participant.
|
3 months after enrollment
|
|
To investigate whether the effect of the Qigong program on reducing dissociative symptoms persists over time
Lasso di tempo: 5 months after enrollement
|
Change in the mean DES-II score between T2 and T1 (T2 - T1).
This change will be calculated for each participant.
|
5 months after enrollement
|
|
To explore the experiences of patients who participated in Qi Gong sessions following the intervention.
Lasso di tempo: 3 month after enrollment
|
The experiences of patients who participated in Qi Gong sessions were assessed through focus groups held after each Qi Gong session, in the form of a debriefing,
|
3 month after enrollment
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2025/RUN/0030
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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