NCT06616337

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 21, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 27, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2025

Completed
Last Updated

October 1, 2024

Status Verified

May 1, 2024

Enrollment Period

1.1 years

First QC Date

May 21, 2024

Last Update Submit

September 26, 2024

Conditions

Keywords

Emotional DysregulationSchizophreniaBipolar disorderBorderline personality disorderAttention deficit hyperactivity disorder (ADHD)

Outcome Measures

Primary Outcomes (1)

  • 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%).

    Up to 1 year

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Subject having expressed their opposition to the reuse of their personal data for scientific research purposes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Psychiatrie 2 - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

SchizophreniaBipolar DisorderBorderline Personality DisorderAttention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood DisordersPersonality DisordersAttention Deficit and Disruptive Behavior DisordersNeurodevelopmental Disorders

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2024

First Posted

September 27, 2024

Study Start

November 21, 2023

Primary Completion

January 1, 2025

Study Completion

January 21, 2025

Last Updated

October 1, 2024

Record last verified: 2024-05

Locations