NCT07670663

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
30mo left

Started Sep 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 26, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

June 26, 2026

Status Verified

June 1, 2026

Enrollment Period

2.3 years

First QC Date

June 22, 2026

Last Update Submit

June 22, 2026

Conditions

Keywords

dissociative symptomschildhood traumaQi- Qong

Outcome Measures

Primary Outcomes (2)

  • Reduction in dissociative symptoms

    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

    Change in mean ITQ scores between T1 and T0 (T1-T0); this change will be calculated for each participant.

    3 months after enrollment

Secondary Outcomes (4)

  • To assess whether participation in the Qigong program leads to an increase in the level of mindfulness

    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

    3 months after enrollment

  • To investigate whether the effect of the Qigong program on reducing dissociative symptoms persists over time

    5 months after enrollement

  • To explore the experiences of patients who participated in Qi Gong sessions following the intervention.

    3 month after enrollment

Study Arms (2)

Qi-gong

EXPERIMENTAL

One Qi Gong session per week for 12 weeks, in groups of six, led by a certified professional.

Other: Qi-Gong

Routine Care (without Qi Gong)

NO INTERVENTION

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

Interventions

Qi-GongOTHER

1 Qi Gong session per week for 12 weeks

Qi-gong

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Qigong

Intervention Hierarchy (Ancestors)

Breathing ExercisesMind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2026

First Posted

June 26, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

March 1, 2029

Last Updated

June 26, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share