Trauma, PsychologicalYOGA-EMDRNCT04431531
EMDR Pre-treatment Yoga for Complex Trauma
A study testing 10 Sessions of yogatherapy associate with EMDR and The second group will have EMDR without yogatherapy in people with Trauma, Psychological, run by Dominique JANUEL at 2 sites in France.
Trial summary
yoga is a technique of hope. Indeed, it is a practice that specifically combines postures, breathing technique and a state meditative. The combination of these elements produces multiple effects that are exposed to detailed in the publications of Bessel Van der Kolk (Price et al., 2017; Rhodes, Spinazzola, \& van der… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Trauma, Psychological
- What is being tested?
- 10 Sessions of yogatherapy associate with EMDR and The second group will have EMDR without yogatherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesFrance
- Study dates
- 20 Sep 2016to 6 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- . Women
- Meets diagnostic criteria for Complex Post-traumatic Stress Disorder according to ICD-11 criteria, related to childhood sexual abuse
- PCL-5 must be at least 45
- Age between 18 and 70.
- Free, informed and signed consent.
Who cannot join
- Neurological disorders
- Pregnant women
- Severe and/or unstable somatic diseases
- Diseases resulting in serious motor disorders (e.g. people paralyzed)
- Patient not affiliated with social security, State Medical Aid (AME)
- Patient hospitalized under stress in psychiatric care at the decision of the state representative or in psychiatric care at the request of a third party,
Show all 10Show fewer
- Patient under guardianship, curatorship and protection of justice
- Patient participating in parallel biomedical research
- French language not mastered
- Persons unable to give consent
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Ch Ville Evrard
Neuilly-sur-Marne, 93330
Florence Durand, MSC, f.durand@epsve.fr
Dominique Januel, MBBS
- Recruiting
Center for Psychotherapy and Psychotraumatology
Saint-Denis, 93200
camille ALLENE, MSC, c.allene@epsve.fr
khalid KALALOU, MBBS
About this study
Official title: EMDR Pre-treatment Yoga for Complex Trauma Randomized Controlled Comparative Study
yoga is a technique of hope. Indeed, it is a practice that specifically combines postures, breathing technique and a state meditative. The combination of these elements produces multiple effects that are exposed to detailed in the publications of Bessel Van der Kolk (Price et al., 2017; Rhodes, Spinazzola, \& van der Kolk, 2016; Van der Kolk, 2014; Van Der Kolk et al., 2014) and whose four main effects are summarized here:
- A regulation of the level of vigilance
- An improvement in self-awareness
- An increased sense of self-efficacy
- Improved metacognition, awareness and regulation emotional
Read the detailed description
Yoga practice has shown benefits in treating multiple physical or mental disorders (Barnes, Bloom, \& Nahin, 2008; Khalsa, 2004; Ross, Friedmann, Bevans, \& Thomas, 2013) and has recently been evaluated for PTSD. We identified six randomized controlled studies measuring the effect of yoga in women (mostly) who experienced childhood violence (see table). With the exception of one pilot study (Dick, Niles, Street, Dimartino, \& Mitchell, 2014; Mitchell et al., 2014), all studies show a significant reduction in PTSD symptoms compared to the pre-treatment period and compared to the control group (waiting list group). In particular, it was shown that this reduction in symptomatology was comparable to that of other commonly practiced psychotherapies, such as the exposure techniques of Behavioural and Cognitive Therapies or EMDR, and comparable to pharmacological treatments (Van Der Kolk et al., 2014). Prolonged yoga therapy would also significantly improve dissociative symptoms (Price et al., 2017). However, all these studies tested the effect of yoga therapy in isolation, without associating it with conventional and recommended treatments for trauma. However, given the fields of action of the yoga listed above, we think that it could be the ideal tool to prepare (in the pre-treatment phase) the work on traumatic memory. We believe that the combination of yoga therapy and EMDR would work in synergy to reduce complex PTSD and achieve a higher success rate than these individual approaches. In this work, we will use a yoga technique adapted to the treatment of psycho-trauma called "trauma sensitive yoga" (Emerson, 2015).
- Conditions
- Trauma, Psychological
- Being tested
- 10 Sessions of yogatherapy associate with EMDR, The second group will have EMDR without yogatherapy
- Keywords
- Yogatherapy-EMDR-psychiatry
- Medical subject headings
- Psychological Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 Sessions of yogatherapy associate with EMDROther
Also called The second group will have EMDR without yogatherapy
The first group will have Yogatherapy plus EMDR treatment
The second group will have EMDR without yogatherapyOther
the second one will have EMDR treatment
| Study group | Role | What they receive |
|---|---|---|
| yogatherapy-EMDR | Active comparator | one of the two groups will have yogatherapy treatment and Eye movement desensibilization reprocessing (EMDR) Receives: Other: 10 Sessions of yogatherapy associate with EMDR |
| waiting list and EMDR | Active comparator | The other group will have Eye movement desensibilization reprocessing Receives: Other: The second group will have EMDR without yogatherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCL-5: Scale of post-traumatic stress disorder
PTSD Scale :
Evaluation of clinical symptomatology and severity of PTSD
Measured: first week
PCL-5: Scale of post-traumatic stress disorder
PTSD Scale :
Evaluation of clinical symptomatology and severity of PTSD
Measured: At twenty week
Secondary outcomes (3)
CAPS-5: PTSD Scale Administered by Clinician
Evaluation of clinical symptomatology and severity of PTSD Diagnosis of comorbidities
Measured: First week
CAPS-5: PTSD Scale Administered by Clinician
Evaluation of clinical symptomatology and severity of PTSD Diagnosis of comorbidities
Measured: At ten week
CAPS-5: PTSD Scale Administered by Clinician
Evaluation of clinical symptomatology and severity of PTSD Diagnosis of comorbidities
Measured: At twenty week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start20 Sep 2016
- Primary completion30 Sep 2024 (estimated)
- Study completion6 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- the first group is about EMDR treatment. The second group is about YOGATHERAPY
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dominique JANUEL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dominique JANUEL, Centre hospitalier de Ville-Evrard, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04431531
- Sponsor's protocol ID
- 10477M-YOGA-EMDR
- Acronym
- YOGA-EMDR
- Status last verified
- Mar 2024
- First submitted
- 11 Jun 2020
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMDR Pre-treatment Yoga for Complex Trauma Randomized Controlled Comparative Study
- ClinicalTrials.gov ID
- NCT04431531
- Acronym / sponsor ID
- YOGA-EMDR / 10477M-YOGA-EMDR
- Conditions
- Trauma, Psychological
- Keywords
- Yogatherapy-EMDR-psychiatry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Dominique JANUELUniversity, hospital or other
- Study start
- 20 Sep 2016 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 6 Sep 2026 (estimated)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
yoga is a technique of hope. Indeed, it is a practice that specifically combines postures, breathing technique and a state meditative. The combination of these elements produces multiple effects that are exposed to detailed in the publications of Bessel Van der Kolk (Price et al., 2017; Rhodes, Spinazzola, \& van der Kolk, 2016; Van der Kolk, 2014; Van Der Kolk et al., 2014) and whose four main effects are summarized here:
- A regulation of the level of vigilance
- An improvement in self-awareness
- An increased sense of self-efficacy
- Improved metacognition, awareness and regulation emotional
Detailed description
Yoga practice has shown benefits in treating multiple physical or mental disorders (Barnes, Bloom, \& Nahin, 2008; Khalsa, 2004; Ross, Friedmann, Bevans, \& Thomas, 2013) and has recently been evaluated for PTSD. We identified six randomized controlled studies measuring the effect of yoga in women (mostly) who experienced childhood violence (see table). With the exception of one pilot study (Dick, Niles, Street, Dimartino, \& Mitchell, 2014; Mitchell et al., 2014), all studies show a significant reduction in PTSD symptoms compared to the pre-treatment period and compared to the control group (waiting list group). In particular, it was shown that this reduction in symptomatology was comparable to that of other commonly practiced psychotherapies, such as the exposure techniques of Behavioural and Cognitive Therapies or EMDR, and comparable to pharmacological treatments (Van Der Kolk et al., 2014). Prolonged yoga therapy would also significantly improve dissociative symptoms (Price et al., 2017). However, all these studies tested the effect of yoga therapy in isolation, without associating it with conventional and recommended treatments for trauma. However, given the fields of action of the yoga listed above, we think that it could be the ideal tool to prepare (in the pre-treatment phase) the work on traumatic memory. We believe that the combination of yoga therapy and EMDR would work in synergy to reduce complex PTSD and achieve a higher success rate than these individual approaches. In this work, we will use a yoga technique adapted to the treatment of psycho-trauma called "trauma sensitive yoga" (Emerson, 2015).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- the first group is about EMDR treatment. The second group is about YOGATHERAPY
| Arm | Type | Receives |
|---|---|---|
| yogatherapy-EMDR | Active comparator | Other: 10 Sessions of yogatherapy associate with EMDRone of the two groups will have yogatherapy treatment and Eye movement desensibilization reprocessing (EMDR) |
| waiting list and EMDR | Active comparator | Other: The second group will have EMDR without yogatherapyThe other group will have Eye movement desensibilization reprocessing |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- . Women
- Meets diagnostic criteria for Complex Post-traumatic Stress Disorder according to ICD-11 criteria, related to childhood sexual abuse
- PCL-5 must be at least 45
- Age between 18 and 70.
- Free, informed and signed consent.
Key exclusion criteria (10 listed)
- Neurological disorders
- Pregnant women
- Severe and/or unstable somatic diseases
- Diseases resulting in serious motor disorders (e.g. people paralyzed)
- Patient not affiliated with social security, State Medical Aid (AME)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10 Sessions of yogatherapy associate with EMDRAlso: The second group will have EMDR without yogatherapyThe first group will have Yogatherapy plus EMDR treatment | Other | yogatherapy-EMDR |
| The second group will have EMDR without yogatherapythe second one will have EMDR treatment | Other | waiting list and EMDR |
Primary outcome
PCL-5: Scale of post-traumatic stress disorder
Time frame: first week
PTSD Scale : Evaluation of clinical symptomatology and severity of PTSD
PCL-5: Scale of post-traumatic stress disorder
Time frame: At twenty week
PTSD Scale : Evaluation of clinical symptomatology and severity of PTSD
3 secondary outcomes
CAPS-5: PTSD Scale Administered by Clinician
Time frame: First week
CAPS-5: PTSD Scale Administered by Clinician
Time frame: At ten week
CAPS-5: PTSD Scale Administered by Clinician
Time frame: At twenty week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10 Sessions of yogatherapy associate with EMDR and The second group will have EMDR without yogatherapy in people with Trauma, Psychological, run by Dominique JANUEL at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rusheenthira THAVASEELAN, MSC (0143093232, r.thavaseelan@epsve.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PCL-5: Scale of post-traumatic stress disorder (time frame: first week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.