Progression of a Group of Patients Suffering From Emotional Dysregulation But Heterogeneous in Terms of Diagnosis, Benefiting From the DBT Group Programme. (PEAC-TRE)

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%).

Study Overview

• Status: Recruiting
• Conditions: Emotional Disorder; Emotion Regulation
• Intervention / Treatment: Behavioral: Group programme for DBT training

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 Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yohann MASSE, nurse; Phone Number: +33 (0)477127159; Email: cirps@chu-st-etienne.fr

Study Locations

• France
  • Saint Priest En Jarez
    • St Etienne, Saint Priest En Jarez, France, 42055
      • Recruiting
      • Chu Saint Etienne
      • Contact: Yohann MASSE, nurse; Email: cirps@chu-st-etienne.fr
      • Principal Investigator: Yohann MASSE, nurse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Psychotic disorders,
• Melancholic depression,
• Aggressive and hostile behaviour preventing group work,
• Intellectual deficit,
• Patient under guardianship.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study patients; Patients all suffering from emotional dysregulation but heterogeneous in terms of diagnosis and following a group DBT training programme.	Behavioral: Group programme for DBT training; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Weeks 1 and 16.

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Groupement Interrégional de Recherche Clinique et d'Innovation
• Investigators: Principal Investigator: Yohann MASSE, nurse, CHU Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2025
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: August 27, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 29, 2024

Study Record Updates

• Last Update Posted (Actual): June 22, 2025
• Last Update Submitted That Met QC Criteria: June 19, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: emotional dysregulation; behaviour therapy; training programme; heterogeneous diagnostic groups
• Other Study ID Numbers: 20GI281; 2021-A02033-38 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No