NCT06577675|Recruiting
Progression of a Group of Patients Suffering From Emotional Dysregulation But Heterogeneous in Terms of Diagnosis, Benefiting From the DBT Group Programme.
PEAC-TRE
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PEAC-TRE
Sponsor study identifier
Secondary identifiers
OTHER · ANSM
interventional
32
1 country
1
Study Start
April 17, 2025
Actual (reported)Primary Completion
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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%).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 27, 2024
Actual (reported)August 29, 2024
Actual (reported)April 17, 2025
Actual (reported)September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Weeks 1, 7, 12 and 16
Quality of life measured by the World Health Organization Quality of Life (WHOQOL-BREF)
Weeks 1 and 16.
Patients all suffering from emotional dysregulation but heterogeneous in terms of diagnosis and following a group DBT training programme.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Chu Saint Etienne
Saint-Etienne, Saint Priest En Jarez, 42055, France
Yohann MASSE, nurse
Centre Hospitalier Universitaire de Saint Etienne
First Submitted
August 27, 2024
First Posted
August 29, 2024
Study Start
April 17, 2025
Actual (reported)Primary Completion
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Contact the study team to confirm eligibility.
Study Completion
May 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 7, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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