- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Olivier Martinez, Mr
- Telefonnummer: 0262 262570169
- E-mail: olivier.martinez@chu-reunion.fr
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
|
|
Ingen indgriben: 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Reduction in dissociative symptoms
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
To assess whether participation in the Qigong program leads to an increase in the level of mindfulness
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2025/RUN/0030
Plan for individuelle deltagerdata (IPD)
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