Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

90

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. januar 2029

Studieafslutning (Anslået)

1. marts 2029

Datoer for studieregistrering

Først indsendt

22. juni 2026

Først indsendt, der opfyldte QC-kriterier

22. juni 2026

Først opslået (Faktiske)

26. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Qi-Gong

Abonner