- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Olivier Martinez, Mr
- Phone Number: 0262 262570169
- Email: olivier.martinez@chu-reunion.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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
|
|
No Intervention: 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reduction in dissociative symptoms
Time Frame: 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
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To assess whether participation in the Qigong program leads to an increase in the level of mindfulness
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Time Frame: 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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025/RUN/0030
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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