Emotional DysregulationDys-EmotionNCT06616337
Patients Suffering From Emotional Dysregulation
An observational study of Emotional Dysregulation, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Emotional dysregulation (ED) is a common syndrome in psychiatric disorders. It is characterized by intense emotions, easily triggered, and with significant psychological impact: explosions of anger, irritability, impulsivity, emotional lability, etc. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emotional Dysregulation
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 21 Nov 2023to 21 Jan 2025
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Major subject (≥18 years old) having participated in the first session of a GREMO group, which is a behavioral and dialectical therapy protocol during the period from January 1, 2018 to December 31, 2023.
Who may be able to join
- Major subject (≥18 years old)
- Having participated in the first session of a GREMO group, which is a behavioral and dialectical therapy protocol from January 1, 2018 to December 31, 2023,
- Subject not opposing the reuse of their data for scientific research purposes.
Who cannot join
- Subject having expressed their opposition to the reuse of their personal data for scientific research purposes.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Psychiatrie 2 - CHU de Strasbourg - France
Strasbourg, 67091
Sébastien WEIBEL, MD, 33 3 88 11 51 57, sebastien.weibel@chru-strasbourg.fr
Sébastien WEIBEL, MD
About this study
Official title: Retrospective Study of the Acceptability and Effectiveness of a Dialectical Behavioral Therapy Group in Patients Suffering From Emotional Dysregulation (Borderline Personality Disorder, Bipolar Disorder and Adult ADHD)
Emotional dysregulation (ED) is a common syndrome in psychiatric disorders. It is characterized by intense emotions, easily triggered, and with significant psychological impact: explosions of anger, irritability, impulsivity, emotional lability, etc. It is systematic in borderline personality disorder, and observed in a majority of patients with bipolar disorder. (even in the interictal period), adult ADHD, or addictions. ED is a cause of psychological distress, suicidal behavior or non-suicidal self-injury, and impaired quality of life. Pharmacological treatments only very partially improve these symptoms. Psychotherapies aimed at reducing ED are poorly developed in France. Dialectical behavioral therapy is a therapy that has shown its effectiveness in ED of BPD.
This is why the psychiatry and addiction center of the University Hospitals of Strasbourg has set up groups using this psychotherapeutic approach based on this technique for almost 3 years. This technique being very little practiced in France, and even less studied, we want to see if it is adapted to a French population not accustomed to this type of practice.
- Conditions
- Emotional Dysregulation
- Keywords
- Emotional Dysregulation, Schizophrenia, Bipolar disorder, Borderline personality disorder, Attention deficit hyperactivity disorder (ADHD)
- Medical subject headings
- Schizophrenia, Bipolar Disorder, Borderline Personality Disorder, Attention Deficit Disorder with Hyperactivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the change of symptoms of emotional dysregulation
- The assessment is based on the DERS scale. Participants are asked to indicate how often the items apply to themselves, with responses ranging from 1 to 5,
- The score between :
- 1 means almost never (0 to 10%),
- 2 means sometimes (11 to 35%),
- 3 means about half the time (36 to 65%),
- 4 means most of the time (66 to 90%),
- 5 means almost always (91 to 100%).
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start21 Nov 2023
- Primary completionJan 2025 (estimated)
- Study completion21 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional DysregulationStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616337
- Sponsor's protocol ID
- 9137
- Acronym
- Dys-Emotion
- Status last verified
- May 2024
- First submitted
- 21 May 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of the Acceptability and Effectiveness of a Dialectical Behavioral Therapy Group in Patients Suffering From Emotional Dysregulation (Borderline Personality Disorder, Bipolar Disorder and Adult ADHD)
- ClinicalTrials.gov ID
- NCT06616337
- Acronym / sponsor ID
- Dys-Emotion / 9137
- Conditions
- Emotional Dysregulation
- Keywords
- Emotional Dysregulation, Schizophrenia, Bipolar disorder, Borderline personality disorder, Attention deficit hyperactivity disorder (ADHD)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- 21 Jan 2025 (estimated)
- First posted
- 27 Sep 2024 (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.
Emotional dysregulation (ED) is a common syndrome in psychiatric disorders. It is characterized by intense emotions, easily triggered, and with significant psychological impact: explosions of anger, irritability, impulsivity, emotional lability, etc. It is systematic in borderline personality disorder, and observed in a majority of patients with bipolar disorder. (even in the interictal period), adult ADHD, or addictions. ED is a cause of psychological distress, suicidal behavior or non-suicidal self-injury, and impaired quality of life. Pharmacological treatments only very partially improve these symptoms. Psychotherapies aimed at reducing ED are poorly developed in France. Dialectical behavioral therapy is a therapy that has shown its effectiveness in ED of BPD.
This is why the psychiatry and addiction center of the University Hospitals of Strasbourg has set up groups using this psychotherapeutic approach based on this technique for almost 3 years. This technique being very little practiced in France, and even less studied, we want to see if it is adapted to a French population not accustomed to this type of practice.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Major subject (≥18 years old) having participated in the first session of a GREMO group, which is a behavioral and dialectical therapy protocol during the period from January 1, 2018 to December 31, 2023.
Key inclusion criteria (3 listed)
- Major subject (≥18 years old)
- Having participated in the first session of a GREMO group, which is a behavioral and dialectical therapy protocol from January 1, 2018 to December 31, 2023,
- Subject not opposing the reuse of their data for scientific research purposes.
Key exclusion criteria (1 listed)
- Subject having expressed their opposition to the reuse of their personal data for scientific research purposes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the change of symptoms of emotional dysregulation
Time frame: Up to 1 year
* The assessment is based on the DERS scale. Participants are asked to indicate how often the items apply to themselves, with responses ranging from 1 to 5, * The score between : * 1 means almost never (0 to 10%), * 2 means sometimes (11 to 35%), * 3 means about half the time (36 to 65%), * 4 means most of the time (66 to 90%), * 5 means almost always (91 to 100%).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emotional Dysregulation, run by University Hospital, Strasbourg, France at 1 site 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 3 inclusion and 1 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 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Sébastien WEIBEL, MD (33 3 88 11 51 57, sebastien.weibel@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the change of symptoms of emotional dysregulation (time frame: Up to 1 year). 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 1 Oct 2024; AzTrials last refreshed its copy on 6 Nov 2026.