Improving emotions and behaviors after brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study evaluates the effectiveness of Dialectical Behavior Therapy (DBT) for individuals with acquired brain injury (ABI) who experience emotional and behavioral challenges. The study employs a triple methodology, including a monocentric, comparative, open-label design with active control treatment, and focuses on the impact of DBT skills training on patients and their families. Participants will engage in group and individual sessions aimed at enhancing emotional regulation, self-esteem, and overall quality of life while also exploring the experience of free will and spirituality post-injury.

Why it matters

Who can join: the full rules

Eligibility Criteria: \* (Limit: 15,000 characters)

Summary criteria for participant selection.

Main eligibility criteria

GREMO patients :

* Inclusion criteria:

  * Persons with acquired brain injury regardless of the type or location of the injury
  * Age between 18 and 68
  * Over 18 months since the acquired brain injury (or 6 month if mild traumatic brain injury)
  * Challenging behaviors or emotional dysregulation or high level of anxiety / depression or family's complaints about emotional dysregulation
  * Secondary or exacerbated by an acquired brain injury
  * Causing important suffering for themselves or their families
  * Being affiliated to a social security
  * Fluent in French
  * Being able to understand goals and risks and to give a dated and signed consent
* Exclusion criteria:

  * Clinically evident severe lack of insight, lack of abstract reasoning, or severe anosognosia
  * Patients without any complaints
  * Severe cognitive impairments, aphasia or intellectual impairments that doesn't allow to understand DBT skills, questionnaires or group intreactions
  * Non fluent in French
  * Associated brain degenerative disease
  * Cancerous brain injury with uncertain progression
  * Non-stabilized psychotic disorder
  * Following a third wave cognitive behavioral therapy during the research study (for example : acceptance and commitment therapy)

Controls without brain injury

* Inclusion criteria :

  * Being 18 years old or more
  * Without brain injury
* Exclusion criteria :

  * Non fluent in French
  * History of brain injury or brain disease
  * History of psychiatric disorder
  * Personality disorder
  * GREMO patient's family member living together
  * Psychologist, neuropsychologist or people with an emotional regulation knowledge linked to their profession
  * Being under guardianship or curatorship
  * Being pregnant or breastfeeding

GREMO patients' family members

* Inclusion criteria :

  * Being 18 years old or more
  * GREMO patient's family member
  * Living with a GREMO patient
  * Agreeing to rate an emotion-behavior-skills diary cards
* Exclusion criteria :

  * GREMO patient's refusal for their family member to participate
  * Non fluent in French
  * Brain injury or brain disease
  * Major lack of insight
  * Being under trusteeship or curatorship

Qualitative research ABI patients and families

* Inclusion criteria :

  * Person with ABI attending the same medico-social service as GREMO patients
  * Ineligible for GREMO patients group (participation refusal, major insight difficulty…)
  * Agreeing to talk about their free will or spirituality
* Exclusion criteria :

  * Aphasia or dysarthria not allowing understandable recording
  * Impossibility to understand oral questions
  * Non fluent in French

Where it's running

• Service EMOI-TC - Pôle de MPR Institut Universitaire de Réadaptation Clemenceau (IURC)
  Illkirch-Graffenstaden, France Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.