Emotion RegulationPEAC-TRENCT06577675
Progression of a Group of Patients Suffering From Emotional Dysregulation But Heterogeneous in Terms of Diagnosis, Benefiting From the DBT Group Programme.
A study testing Group programme for DBT training in people with Emotion Regulation and Emotional Disorder, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Human beings experience emotions and have the ability to manage them, but when these abilities are undermined by mental illness, the result is emotional dysregulation. Borderline patients (1 to 4% of the population) suffer from this symptom and can benefit from a specific therapy: DBT (Dialectical Behaviour Therapy… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Emotion Regulation, Emotional Disorder
- What is being tested?
- Group programme for DBT training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 17 Apr 2025to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients affiliated to or entitled under a social security scheme
- Patients aged 18 to 65 suffering from emotional dysregulation and presenting one of the following clinical profiles: borderline disorder, bipolar disorder, addictive disorders, eating disorders, PTSD.
- Follow-up by the Saint Etienne sector (mobile teams, psychological medical centre, intra-hospital services, full-time therapeutic reception centre and day hospitals).
- DERS scale score > 94.
- Patient having received informed information about the study and having signed consent to participate in the study.
Who cannot join
- Psychotic disorders,
- Melancholic depression,
- Aggressive and hostile behaviour preventing group work,
- Intellectual deficit,
- Patient under guardianship.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Saint Etienne
Saint-Etienne, Saint Priest En Jarez, 42055
Yohann MASSE, nurse, cirps@chu-st-etienne.fr
Yohann MASSE, nurse
About this study
Human beings experience emotions and have the ability to manage them, but when these abilities are undermined by mental illness, the result is emotional dysregulation. Borderline patients (1 to 4% of the population) suffer from this symptom and can benefit from a specific therapy: DBT (Dialectical Behaviour Therapy; Linehan, 1993). Created specifically for this condition, DBT significantly reduces emotional dysregulation, a dimension at the root of behavioural disorders that is known to be poorly relieved by drug treatments. The DBT group training programme offers patients the opportunity to learn and practise emotional regulation skills. Four types of skills are taught skills: mindfulness, interpersonal skills, emotional regulation and and distress tolerance. This therapy is part of the psychiatric care, in which patients take responsibility in their own care.
There are many studies showing the effectiveness of DBT and its programme with borderline patients. But there are other pathologies concerned by emotional dysregulation: thymic disorders in particular bipolar (1 to 2.5%), addictive disorders (8 to 10%), eating disorders (ADD, 10%), post-traumatic stress disorder (PTSD, 2%).
Read the detailed description
A few other studies have demonstrated the efficacy of DBT in patients suffering from other psychiatric disorders (antisocial personality, addictive disorders, particularly alcohol, eating disorders). However, no study has attempted to test the impact of DBT on emotional regulation in a diagnostically heterogeneous group of patients.
The investigators therefore propose, for the first time, to group together different pathologies in the field of emotional regulation disorders (borderline disorders, thymic disorders including bipolarity, anxiety disorders including PTSD, addictive disorders, eating disorders) in order to study the specific influence of the DBT programme on these emotional dysfunctions as its main objective.
The aim of this study is to describe the evolution of a group of diagnostically heterogeneous patients (Borderline Disorder, Bipolar Disorder, Addictive Disorders, CAT Disorders, PTSD) suffering from emotional dysregulation, benefiting from the DBT group programme, in a reduced version of this therapy, since it will take place over 4 to 5 months.
- Conditions
- Emotion Regulation, Emotional Disorder
- Being tested
- Group programme for DBT training
- Keywords
- emotional dysregulation, training programme, behaviour therapy, heterogeneous diagnostic groups
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group programme for DBT trainingBehavioural
This programme comprises 16 sessions over approximately 5 to 6 months, with one 2.5-hour session every week in a closed group of 8 patients. These sessions will be supervised by two or four carers trained in DBT.
| Study group | Role | What they receive |
|---|---|---|
| Study patients | Experimental | Patients all suffering from emotional dysregulation but heterogeneous in terms of diagnosis and following a group DBT training programme. Receives: Behavioral: Group programme for DBT training |
What is being measured
The primary outcome is the main question the study is designed to answer.
DERS (Difficulties in Emotion Regulation Scale)
Measures six dimensions of emotion regulation. The 36 items are scored on a 5-point Likert scale.
The score is between 36 and 180, 36 for no emotional difficulty and 180 for maximum emotional dysregulation. The higher the score, the greater the difficulty the subject has in emotion regulation.
Measured: Weeks 1, 7, 12 and 16
Secondary outcomes (1)
Quality of life measured by the World Health Organization Quality of Life (WHOQOL-BREF)
This scale is a 26-item self-questionnaire exploring four domains (physical health, psychological health, social relationships, environment) and two global factors that assess general life satisfaction and sense of personal well-being. Each response is coded on a 5-point Likert scale. The results for each domain give a raw score which, according to the conversion grid, gives a score ranging from 0 to 100 for each domain, with 100 corresponding to a high quality of life.
Measured: Weeks 1 and 16.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start17 Apr 2025
- Primary completionSep 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotion RegulationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Groupement Interrégional de Recherche Clinique et d'Innovation
- Responsible party
- Sponsor
- Investigators
- Yohann MASSE, nurse, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06577675
- Sponsor's protocol ID
- 20GI281
- Other IDs
- 2021-A02033-38
- Acronym
- PEAC-TRE
- Status last verified
- Oct 2026
- First submitted
- 27 Aug 2024
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progression of a Group of Patients Suffering From Emotional Dysregulation But Heterogeneous in Terms of Diagnosis, Benefiting From the DBT Group Programme.
- ClinicalTrials.gov ID
- NCT06577675
- Acronym / sponsor ID
- PEAC-TRE / 20GI281
- Conditions
- Emotion Regulation, Emotional Disorder
- Keywords
- emotional dysregulation, training programme, behaviour therapy, heterogeneous diagnostic groups
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Groupement Interrégional de Recherche Clinique et d'Innovation
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 29 Aug 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.
Human beings experience emotions and have the ability to manage them, but when these abilities are undermined by mental illness, the result is emotional dysregulation. Borderline patients (1 to 4% of the population) suffer from this symptom and can benefit from a specific therapy: DBT (Dialectical Behaviour Therapy; Linehan, 1993). Created specifically for this condition, DBT significantly reduces emotional dysregulation, a dimension at the root of behavioural disorders that is known to be poorly relieved by drug treatments. The DBT group training programme offers patients the opportunity to learn and practise emotional regulation skills. Four types of skills are taught skills: mindfulness, interpersonal skills, emotional regulation and and distress tolerance. This therapy is part of the psychiatric care, in which patients take responsibility in their own care.
There are many studies showing the effectiveness of DBT and its programme with borderline patients. But there are other pathologies concerned by emotional dysregulation: thymic disorders in particular bipolar (1 to 2.5%), addictive disorders (8 to 10%), eating disorders (ADD, 10%), post-traumatic stress disorder (PTSD, 2%).
Detailed description
A few other studies have demonstrated the efficacy of DBT in patients suffering from other psychiatric disorders (antisocial personality, addictive disorders, particularly alcohol, eating disorders). However, no study has attempted to test the impact of DBT on emotional regulation in a diagnostically heterogeneous group of patients.
The investigators therefore propose, for the first time, to group together different pathologies in the field of emotional regulation disorders (borderline disorders, thymic disorders including bipolarity, anxiety disorders including PTSD, addictive disorders, eating disorders) in order to study the specific influence of the DBT programme on these emotional dysfunctions as its main objective.
The aim of this study is to describe the evolution of a group of diagnostically heterogeneous patients (Borderline Disorder, Bipolar Disorder, Addictive Disorders, CAT Disorders, PTSD) suffering from emotional dysregulation, benefiting from the DBT group programme, in a reduced version of this therapy, since it will take place over 4 to 5 months.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study patients | Experimental | Behavioral: Group programme for DBT trainingPatients all suffering from emotional dysregulation but heterogeneous in terms of diagnosis and following a group DBT training programme. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients affiliated to or entitled under a social security scheme
- Patients aged 18 to 65 suffering from emotional dysregulation and presenting one of the following clinical profiles: borderline disorder, bipolar disorder, addictive disorders, eating disorders, PTSD.
- Follow-up by the Saint Etienne sector (mobile teams, psychological medical centre, intra-hospital services, full-time therapeutic reception centre and day hospitals).
- DERS scale score > 94.
- Patient having received informed information about the study and having signed consent to participate in the study.
Key exclusion criteria (5 listed)
- Psychotic disorders,
- Melancholic depression,
- Aggressive and hostile behaviour preventing group work,
- Intellectual deficit,
- Patient under guardianship.
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 |
|---|---|---|
| Group programme for DBT trainingThis programme comprises 16 sessions over approximately 5 to 6 months, with one 2.5-hour session every week in a closed group of 8 patients. These sessions will be supervised by two or four carers trained in DBT. | Behavioural | Study patients |
Primary outcome
DERS (Difficulties in Emotion Regulation Scale)
Time frame: Weeks 1, 7, 12 and 16
Measures six dimensions of emotion regulation. The 36 items are scored on a 5-point Likert scale. The score is between 36 and 180, 36 for no emotional difficulty and 180 for maximum emotional dysregulation. The higher the score, the greater the difficulty the subject has in emotion regulation.
1 secondary outcome
Quality of life measured by the World Health Organization Quality of Life (WHOQOL-BREF)
Time frame: Weeks 1 and 16.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Yohann MASSE, nurse principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group programme for DBT training in people with Emotion Regulation and Emotional Disorder, run by Centre Hospitalier Universitaire de Saint Etienne 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 7 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yohann MASSE, nurse ((0)477127159 ext. +33, cirps@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DERS (Difficulties in Emotion Regulation Scale) (time frame: Weeks 1, 7, 12 and 16). 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 7 Oct 2026.