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

NCT06577675 | Recruiting

• 2 other identifiers: 20GI2812021-A02033-38
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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; 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%).

Conditions

Emotion Regulation; Emotional Disorder

Keywords

emotional dysregulation; training programme; behaviour therapy; heterogeneous diagnostic groups

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Quality of life measured by the World Health Organization Quality of Life (WHOQOL-BREF)

  Weeks 1 and 16.

Study Arms (1)

Study patients

EXPERIMENTAL

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

Interventions

Group programme for DBT training BEHAVIORAL

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 patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Groupement Interrégional de Recherche Clinique et d'Innovation: collaborator

Study Sites (1)

Chu Saint Etienne

Saint-Etienne, Saint Priest En Jarez, 42055, France

RECRUITING

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Study Officials

• Yohann MASSE, nurse

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yohann MASSE, nurse

CONTACT

(0)477127159; cirps@chu-st-etienne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 29, 2024
• Study Start: April 17, 2025
• Primary Completion: September 1, 2025
• Study Completion: May 1, 2026
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)